cfr_sections
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62 rows where part_number = 1271 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 14:14:5.0.1.1.36.1.1.1 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | A | Subpart A—General | § 1271.100 Conditions on use of funds. | NASA | (a) No appropriated funds may be expended by the recipient of a Federal contract, grant, loan, or cooperative ageement to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions: the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement. (b) Each person who requests or receives from an agency a Federal contract, grant, loan, or cooperative agreement shall file with that agency a certification, set forth in appendix A, that the person has not made, and will not make, any payment prohibited by paragraph (a) of this section. (c) Each person who requests or receives from an agency a Federal contract, grant, loan, or a cooperative agreement shall file with that agency a disclosure form, set forth in appendix B, if such person has made or has agreed to make any payment using nonappropriated funds (to include profits from any covered Federal action), which would be prohibited under paragraph (a) of this section if paid for with appropriated funds. (d) Each person who requests or receives from an agency a commitment providing for the United States to insure or guarantee a loan shall file with that agency a statement, set forth in appendix A, whether that person has made or has agreed to make any payment to influence or attempt to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with that loan insurance or guarantee. (e) Each person who requests or receives from an agency a commitment providing for the United States to insure or guarantee a loan shall file with that agency a disclosure form, … | |||||
| 14:14:5.0.1.1.36.1.1.2 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | A | Subpart A—General | § 1271.105 Definitions. | NASA | For purposes of this part: (a) Agency, as defined in 5 U.S.C. 552(f), includes Federal executive departments and agencies as well as independent regulatory commissions and Government corporations, as defined in 31 U.S.C. 9101(1). (b) Covered Federal action means any of the following Federal actions: (1) The awarding of any Federal contract; (2) The making of any Federal grant; (3) The making of any Federal loan; (4) The entering into of any cooperative agreement; and, (5) The extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement. Covered Federal action does not include receiving from an agency a commitment providing for the United States to insure or guarantee a loan. Loan guarantees and loan insurance are addressed independently within this part. (c) Federal contract means an acquisition contract awarded by an agency, including those subject to the Federal Acquisition Regulation (FAR), and any other acquisition contract for real or personal property or services not subject to the FAR. (d) Federal cooperative agreement means a cooperative agreement entered into by an agency. (e) Federal grant means an award of financial assistance in the form of money, or property in lieu of money, by the Federal Government or a direct appropriation made by law to any person. The term does not include technical assistance which provides services instead of money, or other assistance in the form of revenue sharing, loans, loan guarantees, loan insurance, interest subsidies, insurance, or direct United States cash assistance to an individual. (f) Federal loan means a loan made by an agency. The term does not include loan guarantee or loan insurance. (g) Indian tribe and tribal organization have the meaning provided in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450B). Alaskan Natives are included under the definitions of Indian tribes in that Act. (h) Influencing or attempting to influence mea… | |||||
| 14:14:5.0.1.1.36.1.1.3 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | A | Subpart A—General | § 1271.110 Certification and disclosure. | NASA | (a) Each person shall file a certification, and a disclosure form, if required, with each submission that initiates agency consideration of such person for: (1) Award of a Federal contract, grant, or cooperative agreement exceeding $100,000; or (2) An award of a Federal loan or a commitment providing for the United States to insure or guarantee a loan exceeding $150,000. (b) Each person shall file a certification, and a disclosure form, if required, upon receipt by such person of: (1) A Federal contract, grant, or cooperative agreement exceeding $100,000; or (2) A Federal loan or a commitment providing for the United States to insure or guarantee a loan exceeding $150,000, Unless such person previously filed a certification, and a disclosure form, if required, under paragraph (a) of this section. (c) Each person shall file a disclosure form at the end of each calendar quarter in which there occurs any event that requires disclosure or that materially affects the accuracy of the information contained in any disclosure form previously filed by such person under paragraphs (a) or (b) of this section. An event that materially affects the accuracy of the information reported includes: (1) A cumulative increase of $25,000 or more in the amount paid or expected to be paid for influencing or attempting to influence a covered Federal action; or (2) A change in the person(s) or individual(s) influencing or attempting to influence a covered Federal action; or, (3) A change in the officer(s), employee(s), or Member(s) contacted to influence or attempt to influence a covered Federal action. (d) Any person who requests or receives from a person referred to in paragraphs (a) or (b) of this section: (1) A subcontract exceeding $100,000 at any tier under a Federal contract; (2) A subgrant, contract, or subcontract exceeding $100,000 at any tier under a Federal grant; (3) A contract or subcontract exceeding $100,000 at any tier under a Federal loan exceeding $150,000; or, (4) A contract or subcontract exceeding $100… | |||||
| 14:14:5.0.1.1.36.2.1.1 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | B | Subpart B—Activities by Own Employees | § 1271.200 Agency and legislative liaison. | NASA | (a) The prohibition on the use of appropriated funds, in § 1271.100 (a), does not apply in the case of a payment of reasonable compensation made to an officer or employee of a person requesting or receiving a Federal contract, grant, loan, or cooperative agreement if the payment is for agency and legislative liaison activities not directly related to a covered Federal action. (b) For purposes of paragraph (a) of this section, providing any information specifically requested by an agency or Congress is allowable at any time. (c) For purposes of paragraph (a) of this section, the following agency and legislative liaison activities are allowable at any time only where they are not related to a specific solicitation for any covered Federal action: (1) Discussing with an agency (including individual demonstrations) the qualities and characteristics of the person's products or services, conditions or terms of sale, and service capabilities; and, (2) Technical discussions and other activities regarding the application or adaptation of the person's products or services for an agency's use. (d) For purposes of paragraph (a) of this section, the following agencies and legislative liaison activities are allowable only where they are prior to formal solicitation of any covered Federal action: (1) Providing any information not specifically requested but necessary for an agency to make an informed decision about initiation of a covered Federal action; (2) Technical discussions regarding the preparation of an unsolicited proposal prior to its official submission; and, (3) Capability presentations by persons seeking awards from an agency pursuant to the provisions of the Small Business Act, as amended by Public Law 95-507 and other subsequent amendments. (e) Only those activities expressly authorized by this section are allowable under this section. | |||||
| 14:14:5.0.1.1.36.2.1.2 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | B | Subpart B—Activities by Own Employees | § 1271.205 Professional and technical services. | NASA | (a) The prohibition on the use of appropriated funds, in § 1271.100(a), does not apply in the case of a payment of reasonable compensation made to an officer or employee of a person requesting or receiving a Federal contract, grant, loan, or cooperative agreement or an extension, continuation, renewal, amendment, or modification of a Federal contract, grant, loan, or cooperative agreement if payment is for professional or technical services rendered directly in the preparation, submission, or negotiation of any bid, proposal, or application for that Federal contract, grant, loan, or cooperative agreement or for meeting requirements imposed by or pursuant to law as a condition for receiving that Federal contract, grant, loan, or cooperative agreement. (b) For purposes of paragraph (a) of this section, “professional and technical services” shall be limited to advice and analysis directly applying any professional or technical discipline. For example, drafting of a legal document accompanying a bid or proposal by a lawyer is allowable. Similarly, technical advice provided by an engineer on the performance or operational capability of a piece of equipment rendered directly in the negotiation of a contract is allowable. However, communications with the intent to influence made by a professional (such as a licensed lawyer) or a technical person (such as a licensed accountant) are not allowable under this section unless they provide advice and analysis directly applying their professional or technical expertise and unless the advice or analysis is rendered directly and solely in the preparation, submission or negotiation of a covered Federal action. Thus, for example, communications with the intent to influence made by a lawyer that do not provide legal advice or analysis directly and solely related to the legal aspects of his or her client's proposal, but generally advocate one proposal over another are not allowable under this section because the lawyer is not providing professional legal services. Similarly, communi… | |||||
| 14:14:5.0.1.1.36.2.1.3 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | B | Subpart B—Activities by Own Employees | § 1271.210 Reporting. | NASA | No reporting is required with respect to payments of reasonable compensation made to regularly employed officers or employees of a person. | |||||
| 14:14:5.0.1.1.36.3.1.1 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | C | Subpart C—Activities by Other Than Own Employees | § 1271.300 Professional and technical services. | NASA | (a) The prohibition on the use of appropriated funds, in § 1271.100(a), does not apply in the case of any reasonable payment to a person, other than an officer or employee of a person requesting or receiving a covered Federal action, if the payment is for professional or technical services rendered directly in the preparation, submission, or negotiation of any bid, proposal, or application for that Federal contract, grant, loan, or cooperative agreement or for meeting requirements imposed by or pursuant to law as a condition for receiving that Federal contract, grant, loan, or cooperative agreement. (b) The reporting requirements in § 1271.110 (a) and (b) regarding filing a disclosure form by each person, if required, shall not apply with respect to professional or technical services rendered directly in the preparation, submission, or negotiation of any commitment providing for the United States to insure or guarantee a loan. (c) For purposes of paragraph (a) of this section, “professional and technical services” shall be limited to advice and analysis directly applying any professional or technical discipline. For example, drafting or a legal document accompanying a bid or proposal by a lawyer is allowable. Similarly, technical advice provided by an engineer on the performance or operational capability of a piece of equipment rendered directly in the negotiation of a contract is allowable. However, communications with the intent to influence made by a professional (such as a licensed lawyer) or a technical person (such as a licensed accountant) are not allowable under this section unless they provide advice and analysis directly applying their professional or technical expertise and unless the advice or analysis is rendered directly and solely in the preparation, submission or negotiation of a covered Federal action. Thus, for example, communications with the intent to influence made by a lawyer that do not provide legal advice or analysis directly and solely related to the legal aspects of his or her client'… | |||||
| 14:14:5.0.1.1.36.4.1.1 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | D | Subpart D—Penalties and Enforcement | § 1271.400 Penalties. | NASA | [55 FR 6737, 6748, Feb. 26, 1990, as amended at 82 FR 28763, June 26, 2017; 82 FR 48762, Oct. 20, 2017; 83 FR 2046, Jan. 16, 2018; 84 FR 13115, Apr. 4, 2019; 85 FR 16546, Mar. 24, 2020; 86 FR 14245, Mar. 15, 2021; 87 FR 23108, Apr. 19, 2022; 88 FR 24906, Apr. 25, 2023; 89 FR 20107, Mar. 21, 2024; 90 FR 19262, May 7, 2025] | (a) Any person who makes an expenditure prohibited herein shall be subject to a civil penalty of not less than $25,132 and not more than $251,322 for each such expenditure. (b) Any person who fails to file or amend the disclosure form (see appendix B) to be filed or amended if required herein, shall be subject to a civil penalty of not less than $25,132 and not more than $251,322 for each such failure. (c) A filing or amended filing on or after the date on which an administrative action for the imposition of a civil penalty is commenced does not prevent the imposition of such civil penalty for a failure occurring before that date. An administrative action is commenced with respect to a failure when an investigating official determines in writing to commence an investigation of an allegation of such failure. (d) In determining whether to impose a civil penalty, and the amount of any such penalty, by reason of a violation by any person, the agency shall consider the nature, circumstances, extent, and gravity of the violation, the effect on the ability of such person to continue in business, any prior violations by such person, the degree of culpability of such person, the ability of the person to pay the penalty, and such other matters as may be appropriate. (e) First offenders under paragraphs (a) or (b) of this section shall be subject to a civil penalty of $25,132, absent aggravating circumstances. Second and subsequent offenses by persons shall be subject to an appropriate civil penalty between $25,132 and $251,322, as determined by the agency head or his or her designee. (f) An imposition of a civil penalty under this section does not prevent the United States from seeking any other remedy that may apply to the same conduct that is the basis for the imposition of such civil penalty. | ||||
| 14:14:5.0.1.1.36.4.1.2 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | D | Subpart D—Penalties and Enforcement | § 1271.405 Penalty procedures. | NASA | Agencies shall impose and collect civil penalties pursuant to the provisions of the Program Fraud and Civil Remedies Act, 31 U.S.C. sections 3803 (except subsection (c)), 3804, 3805, 3806, 3807, 3808, and 3812, insofar as these provisions are not inconsistent with the requirements herein. | |||||
| 14:14:5.0.1.1.36.4.1.3 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | D | Subpart D—Penalties and Enforcement | § 1271.410 Enforcement. | NASA | The head of each agency shall take such actions as are necessary to ensure that the provisions herein are vigorously implemented and enforced in that agency. | |||||
| 14:14:5.0.1.1.36.5.1.1 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | E | Subpart E—Exemptions | § 1271.500 Secretary of Defense. | NASA | (a) The Secretary of Defense may exempt, on a case-by-case basis, a covered Federal action from the prohibition whenever the Secretary determines, in writing, that such an exemption is in the national interest. The Secretary shall transmit a copy of each such written exemption to Congress immediately after making such a determination. (b) The Department of Defense may issue supplemental regulations to implement paragraph (a) of this section. | |||||
| 14:14:5.0.1.1.36.6.1.1 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | F | Subpart F—Agency Reports | § 1271.600 Semi-annual compilation. | NASA | (a) The head of each agency shall collect and compile the disclosure reports (see appendix B) and, on May 31 and November 30 of each year, submit to the Secretary of the Senate and the Clerk of the House of Representatives a report containing a compilation of the information contained in the disclosure reports received during the six-month period ending on March 31 or September 30, respectively, of that year. (b) The report, including the compilation, shall be available for public inspection 30 days after receipt of the report by the Secretary and the Clerk. (c) Information that involves intelligence matters shall be reported only to the Select Committee on Intelligence of the Senate, the Permanent Select Committee on Intelligence of the House of Representatives, and the Committees on Appropriations of the Senate and the House of Representatives in accordance with procedures agreed to by such committees. Such information shall not be available for public inspection. (d) Information that is classified under Executive Order 12356 or any successor order shall be reported only to the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives or the Committees on Armed Services of the Senate and the House of Representatives (whichever such committees have jurisdiction of matters involving such information) and to the Committees on Appropriations of the Senate and the House of Representatives in accordance with procedures agreed to by such committees. Such information shall not be available for public inspection. (e) The first semi-annual compilation shall be submitted on May 31, 1990, and shall contain a compilation of the disclosure reports received from December 23, 1989 to March 31, 1990. (f) Major agencies, designated by the Office of Management and Budget (OMB), are required to provide machine-readable compilations to the Secretary of the Senate and the Clerk of the House of Representatives no later than with the compilations due on May 31, 1991. OMB sha… | |||||
| 14:14:5.0.1.1.36.6.1.2 | 14 | Aeronautics and Space | V | 1271 | PART 1271—NEW RESTRICTIONS ON LOBBYING | F | Subpart F—Agency Reports | § 1271.605 Inspector General report. | NASA | (a) The Inspector General, or other official as specified in paragraph (b) of this section, of each agency shall prepare and submit to Congress each year, commencing with submission of the President's Budget in 1991, an evaluation of the compliance of that agency with, and the effectiveness of, the requirements herein. The evaluation may include any recommended changes that may be necessary to strengthen or improve the requirements. (b) In the case of an agency that does not have an Inspector General, the agency official comparable to an Inspector General shall prepare and submit the annual report, or, if there is no such comparable official, the head of the agency shall prepare and submit the annual report. (c) The annual report shall be submitted at the same time the agency submits its annual budget justifications to Congress. (d) The annual report shall include the following: All alleged violations relating to the agency's covered Federal actions during the year covered by the report, the actions taken by the head of the agency in the year covered by the report with respect to those alleged violations and alleged violations in previous years, and the amounts of civil penalties imposed by the agency in the year covered by the report. | |||||
| 21:21:8.0.1.5.59.1.1.1 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | A | Subpart A—General Provisions | § 1271.1 What are the purpose and scope of this part? | FDA | [66 FR 5466, Jan. 19, 2001, as amended at 69 FR 29829, May 25, 2004; 81 FR 60223, Aug. 31, 2016] | (a) Purpose. The purpose of this part, in conjunction with §§ 207.9(a)(5), 210.1(c), 210.2, 807.20(d), and 820.1(a) of this chapter, is to create an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P's) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P's. (b) Scope. (1) If you are an establishment that manufactures HCT/P's that are regulated solely under the authority of section 361 of the Public Health Service Act (the PHS Act), this part requires you to register and list your HCT/P's with the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research and to comply with the other requirements contained in this part, whether or not the HCT/P enters into interstate commerce. Those HCT/P's that are regulated solely under the authority of section 361 of the PHS Act are described in § 1271.10. (2) If you are an establishment that manufactures HCT/P's that are regulated as drugs, devices and/or biological products under section 351 of the PHS Act and/or the Federal Food, Drug, and Cosmetic Act, §§ 207.9(a)(5) and 807.20(d) of this chapter require you to register and list your HCT/P's following the procedures in part 207 (if a drug and/or biological product) of this chapter or part 807 (if a device) of this chapter. Sections 210.1(c), 210.2, 211.1(b), and 820.1(a) of this chapter require you to comply with the donor-eligibility procedures in subpart C of this part and the current good tissue practice procedures in subpart D of this part, in addition to all other applicable regulations. | |||
| 21:21:8.0.1.5.59.1.1.2 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | A | Subpart A—General Provisions | § 1271.3 How does FDA define important terms in this part? | FDA | [66 FR 5466, Jan. 19, 2001, as amended at 68 FR 3826, Jan. 27, 2004; 69 FR 29829, May 25, 2004; 69 FR 68680, Nov. 24, 2004; 81 FR 60223, Aug. 31, 2016] | The following definitions apply only to this part: (a) Autologous use means the implantation, transplantation, infusion, or transfer of human cells or tissue back into the individual from whom the cells or tissue were recovered. (b) Establishment means a place of business under one management, at one general physical location, that engages in the manufacture of human cells, tissues, and cellular and tissue-based products. “Establishment” includes: (1) Any individual, partnership, corporation, association, or other legal entity engaged in the manufacture of human cells, tissues, and cellular and tissue-based products; and (2) Facilities that engage in contract manufacturing services for a manufacturer of human cells, tissues, and cellular and tissue-based products. (c) Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor. (d) Human cells, tissues, or cellular or tissue-based products (HCT/Ps) means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Examples of HCT/Ps include, but are not limited to, bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue. The following articles are not considered HCT/Ps: (1) Vascularized human organs for transplantation; (2) Whole blood or blood components or blood derivative products subject to listing under parts 607 and 207 of this chapter, respectively; (3) Secreted or extracted human products, such as milk, collagen, and cell factors; except that semen is considered an HCT/P; (4) Minimally manipulated bone marrow for homologous use and not combined with another article (except for water, crystalloids, or a s… | |||
| 21:21:8.0.1.5.59.1.1.3 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | A | Subpart A—General Provisions | § 1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do? | FDA | [66 FR 5466, Jan. 19, 2001, as amended at 69 FR 68681, Nov. 24, 2004] | (a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria: (1) The HCT/P is minimally manipulated; (2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent; (3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and (4) Either: (i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or (ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and: ( a ) Is for autologous use; ( b ) Is for allogeneic use in a first-degree or second-degree blood relative; or ( c ) Is for reproductive use. (b) If you are a domestic or foreign establishment that manufactures an HCT/P described in paragraph (a) of this section: (1) You must register with FDA; (2) You must submit to FDA a list of each HCT/P manufactured; and (3) You must comply with the other requirements contained in this part. | |||
| 21:21:8.0.1.5.59.1.1.4 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | A | Subpart A—General Provisions | § 1271.15 Are there any exceptions from the requirements of this part? | FDA | (a) You are not required to comply with the requirements of this part if you are an establishment that uses HCT/P's solely for nonclinical scientific or educational purposes. (b) You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure. (c) You are not required to comply with the requirements of this part if you are a carrier who accepts, receives, carries, or delivers HCT/P's in the usual course of business as a carrier. (d) You are not required to comply with the requirements of this part if you are an establishment that does not recover, screen, test, process, label, package, or distribute, but only receives or stores HCT/P's solely for implantation, transplantation, infusion, or transfer within your facility. (e) You are not required to comply with the requirements of this part if you are an establishment that only recovers reproductive cells or tissue and immediately transfers them into a sexually intimate partner of the cell or tissue donor. (f) You are not required to register or list your HCT/P's independently, but you must comply with all other applicable requirements in this part, if you are an individual under contract, agreement, or other arrangement with a registered establishment and engaged solely in recovering cells or tissues and sending the recovered cells or tissues to the registered establishment. | ||||
| 21:21:8.0.1.5.59.1.1.5 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | A | Subpart A—General Provisions | § 1271.20 If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply? | FDA | [66 FR 5466, Jan. 19, 2001, as amended at 81 FR 60223, Aug. 31, 2016] | If you are an establishment that manufactures an HCT/P that does not meet the criteria set out in § 1271.10(a), and you do not qualify for any of the exceptions in § 1271.15, your HCT/P will be regulated as a drug, device, and/or biological product under the act and/or section 351 of the PHS Act, and applicable regulations in title 21, chapter I. Applicable regulations include, but are not limited to, §§ 207.9(a)(5), 210.1(c), 210.2, 211.1(b), 807.20(d), and 820.1(a) of this chapter, which require you to follow the procedures in subparts C and D of this part. | |||
| 21:21:8.0.1.5.59.2.1.1 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | B | Subpart B—Procedures for Registration and Listing | § 1271.21 When do I register, submit an HCT/P list, and submit updates? | FDA | [69 FR 68681, Nov. 24, 2004] | (a) You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning operations or within 30 days of the effective date of this regulation, whichever is later. (b) You must update your establishment registration annually in December, except as required by § 1271.26. You may accomplish your annual registration in conjunction with updating your HCT/P list under paragraph (c) of this section. (c)(i) If no change described in § 1271.25(c) has occurred since you previously submitted an HCT/P list, you are not required to update your listing. (ii) If a change described in § 1271.25(c) has occurred, you must update your HCT/P listing with the new information: ( a ) At the time of the change, or ( b ) Each June or December, whichever month occurs first after the change. | |||
| 21:21:8.0.1.5.59.2.1.2 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | B | Subpart B—Procedures for Registration and Listing | § 1271.22 How do I register and submit an HCT/P list? | FDA | [81 FR 60223, Aug. 31, 2016] | (a) You must use the electronic registration and listing system at http://www.fda.gov/cber/tissue/tisreg.htm in accordance with § 1271.25 for: (1) Establishment registration, (2) HCT/P listings, and (3) Updates of registration and HCT/P listing. (b) FDA will periodically issue guidance on recommended procedures for providing registration and listing information in electronic format (for example, method of transmission, media, file formats, preparation, and organization of files). (c) You must provide the information under paragraph (a) of this section in accordance with part 11 of this chapter, except for the requirements in § 11.10(b), (c), and (e) and the corresponding requirements in § 11.30. | |||
| 21:21:8.0.1.5.59.2.1.3 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | B | Subpart B—Procedures for Registration and Listing | § 1271.23 How is a waiver from the electronic format requirements requested? | FDA | [81 FR 60224, Aug. 31, 2016] | (a) You may request a waiver from the requirement in § 1271.22 that information must be provided to FDA in electronic format. Submission of a request for waiver does not excuse timely compliance with the registration and listing requirements. FDA will grant a waiver request if FDA determines that the use of electronic means for submission of registration and listing information is not reasonable for the registrant making the waiver request. (b) Waiver requests under this section must be submitted in writing and must include the specific reasons why electronic submission is not reasonable for the registrant and a U.S. telephone number and mailing address where FDA can contact the registrant. Waiver requests may be sent to the Center for Biologics Evaluation and Research (CBER), Document Control Center (see addresses in § 600.2 of this chapter). (c) If FDA grants the waiver request, FDA may limit its duration and will specify terms of the waiver and provide information on how to submit establishment registration, listings, other information, and updates, as applicable. | |||
| 21:21:8.0.1.5.59.2.1.4 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | B | Subpart B—Procedures for Registration and Listing | § 1271.25 What information is required for establishment registration and HCT/P listing? | FDA | [66 FR 5466, Jan. 19, 2001, as amended at 81 FR 60224, Aug. 31, 2016] | (a) Your establishment registration must include: (1) The legal name(s) of the establishment; (2) Each physical location, including the street address, telephone number, email address, and the postal service ZIP code of the establishment; (3) The name, address, telephone number, email address, and title of the reporting official; (4) A dated signature by the reporting official affirming that all information contained in the establishment registration and HCT/P listing form is true and accurate, to the best of his or her knowledge. (5) Each foreign establishment must also submit the name, address, telephone number, and email address of each importer that is known to the establishment, and the name of each person who imports or offers for import such HCT/P to the United States for purposes of importation; and (6) Each foreign establishment must also submit the name, address, telephone number, and email address of its United States agent. (i) The United States agent must reside or maintain a place of business in the United States. (ii) Upon request from FDA, the United States agent must assist FDA in communications with the foreign establishment, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign establishment. If the Agency is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action is equivalent to providing the same information or documents to the foreign establishment. (iii) The foreign establishment or the United States agent must report changes in the United States agent's name, address, telephone number, or email address to FDA within 30 calendar days of the change. (b) Your HCT/P listing must include all HCT/P's (including the established name and the proprietary name) that you recover, process, store, label, package, distribute, or for which you perform donor sc… | |||
| 21:21:8.0.1.5.59.2.1.5 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | B | Subpart B—Procedures for Registration and Listing | § 1271.26 When must I amend my establishment registration? | FDA | [81 FR 60224, Aug. 31, 2017] | If the ownership or location of your establishment changes, or if there is a change in the United States agent's name, address, telephone number, or email address, you must submit an amendment to registration within 30 calendar days of the change. | |||
| 21:21:8.0.1.5.59.2.1.6 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | B | Subpart B—Procedures for Registration and Listing | § 1271.27 Will FDA assign me a registration number? | FDA | (a) FDA will assign each location a permanent registration number. (b) FDA acceptance of an establishment registration and HCT/P listing form does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or approved by FDA. | ||||
| 21:21:8.0.1.5.59.2.1.7 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | B | Subpart B—Procedures for Registration and Listing | § 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings? | FDA | [80 FR 18094, Apr. 3, 2015, as amended at 88 FR 45067, July 14, 2023] | (a) Any registration on Form FDA 3356 filed in paper or electronic format by each establishment will be available for public inspection through the Center for Biologics Evaluation and Research Human Cell and Tissue Establishment Registration—Public Query Web site by using the CBER electronic Web-based application or by going in person to the Food and Drug Administration, Dockets Management Staff Public Reading Room (see address in § 20.120(a) of this chapter). The following information submitted under the HCT/P requirements is illustrative of the type of information that will be available for public disclosure when it is compiled: (1) A list of all HCT/P's; (2) A list of all HCT/P's manufactured by each establishment; (3) A list of all HCT/P's discontinued; and (4) All data or information that has already become a matter of public record. (b) You should direct your other requests for information regarding HCT/P establishment registrations and HCT/P listings to the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002. | |||
| 21:21:8.0.1.5.59.3.1.1 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.45 What requirements does this subpart contain? | FDA | [69 FR 29830, May 25, 2004, as amended at 69 FR 68681, Nov. 24, 2004] | (a) General. This subpart sets out requirements for determining donor eligibility, including donor screening and testing. The requirements contained in this subpart are a component of current good tissue practice (CGTP) requirements. Other CGTP requirements are set out in subpart D of this part. (b) Donor-eligibility determination required. A donor-eligibility determination, based on donor screening and testing for relevant communicable disease agents and diseases, is required for all donors of cells or tissue used in HCT/Ps, except as provided under § 1271.90. In the case of an embryo or of cells derived from an embryo, a donor-eligibility determination is required for both the oocyte donor and the semen donor. (c) Prohibition on use. An HCT/P must not be implanted, transplanted, infused, or transferred until the donor has been determined to be eligible, except as provided under §§ 1271.60(d), 1271.65(b), and 1271.90 of this subpart. (d) Applicability of requirements. If you are an establishment that performs any function described in this subpart, you must comply with the requirements contained in this subpart that are applicable to that function. | |||
| 21:21:8.0.1.5.59.3.1.10 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.90 Are there other exceptions and what labeling requirements apply? | FDA | [69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005; 81 FR 40517, June 22, 2016] | (a) Donor-eligibility determination not required. You are not required to make a donor-eligibility determination under § 1271.50 or to perform donor screening or testing under §§ 1271.75, 1271.80 and 1271.85 for: (1) Cells and tissues for autologous use; or (2) Reproductive cells or tissue donated by a sexually intimate partner of the recipient for reproductive use; or (3) Cryopreserved cells or tissue for reproductive use, other than embryos, originally excepted under paragraphs (a)(1) or (a)(2) of this section at the time of donation, that are subsequently intended for directed donation, provided that: (i) Additional donations are unavailable, for example, due to the infertility or health of a donor of the cryopreserved reproductive cells or tissue; and (ii) Appropriate measures are taken to screen and test the donor(s) before transfer to the recipient. (4) A cryopreserved embryo, originally excepted under paragraph (a)(2) of this section at the time of recovery or cryopreservation, that is subsequently intended for directed or anonymous donation. When possible, appropriate measures should be taken to screen and test the semen and oocyte donors before transfer of the embryo to the recipient. (b) Exceptions for reproductive use. An embryo originally intended for reproductive use for a specific individual or couple that is subsequently intended for directed or anonymous donation for reproductive use is excepted from the prohibition on use under § 1271.45(c) even when the applicable donor eligibility requirements under subpart C of this part are not met. Nothing in this paragraph creates an exception for deficiencies that occurred in making the donor eligibility determination for either the oocyte donor or the semen donor as required under § 1271.45(b), or for deficiencies in performing donor screening or testing, as required under §§ 1271.75, 1271.80, and 1271.85. (c) Required labeling. As applicable, you must prominently label an HCT/P described in paragraphs (a) and (b) of this section as follows:… | |||
| 21:21:8.0.1.5.59.3.1.2 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.47 What procedures must I establish and maintain? | FDA | (a) General. You must establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of this subpart. Establish and maintain means define, document (in writing or electronically), and implement; then follow, review, and as needed, revise on an ongoing basis. You must design these procedures to ensure compliance with the requirements of this subpart. (b) Review and approval. Before implementation, a responsible person must review and approve all procedures. (c) Availability. Procedures must be readily available to the personnel in the area where the operations to which they relate are performed, or in a nearby area if such availability is impractical. (d) Departures from procedures. You must record and justify any departure from a procedure relevant to preventing risks of communicable disease transmission at the time of its occurrence. You must not make available for distribution any HCT/P from a donor whose eligibility is determined under such a departure unless a responsible person has determined that the departure does not increase the risks of communicable disease transmission through the use of the HCT/P. (e) Standard procedures. You may adopt current standard procedures, such as those in a technical manual prepared by another organization, provided that you have verified that the procedures are consistent with and at least as stringent as the requirements of this part and appropriate for your operations. | ||||
| 21:21:8.0.1.5.59.3.1.3 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.50 How do I determine whether a donor is eligible? | FDA | (a) Determination based on screening and testing. If you are the establishment responsible for making the donor-eligibility determination, you must determine whether a donor is eligible based upon the results of donor screening in accordance with § 1271.75 and donor testing in accordance with §§ 1271.80 and 1271.85. A responsible person, as defined in § 1271.3(t), must determine and document the eligibility of a cell or tissue donor. (b) Eligible donor. A donor is eligible under these provisions only if: (1) Donor screening in accordance with § 1271.75 indicates that the donor: (i) Is free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases; and (ii) Is free from communicable disease risks associated with xenotransplantation; and (2) The results of donor testing for relevant communicable disease agents in accordance with §§ 1271.80 and 1271.85 are negative or nonreactive, except as provided in § 1271.80(d)(1). | ||||
| 21:21:8.0.1.5.59.3.1.4 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain? | FDA | [69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005] | (a) Accompanying records. Once a donor-eligibility determination has been made, the following must accompany the HCT/P at all times: (1) A distinct identification code affixed to the HCT/P container, e.g., alphanumeric, that relates the HCT/P to the donor and to all records pertaining to the HCT/P and, except in the case of autologous donations, directed reproductive donations, or donations made by first-degree or second-degree blood relatives, does not include an individual's name, social security number, or medical record number; (2) A statement whether, based on the results of screening and testing, the donor has been determined to be eligible or ineligible; and (3) A summary of the records used to make the donor-eligibility determination. (b) Summary of records. The summary of records required by paragraph (a)(3) of this section must contain the following information: (1) A statement that the communicable disease testing was performed by a laboratory: (i) Certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493; or (ii) That has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services in accordance with those provisions; (2) A listing and interpretation of the results of all communicable disease tests performed; (3) The name and address of the establishment that made the donor-eligibility determination; and (4) In the case of an HCT/P from a donor who is ineligible based on screening and released under paragraph (b) of § 1271.65, a statement noting the reason(s) for the determination of ineligibility. (c) Deletion of personal information. The accompanying records required by this section must not contain the donor's name or other personal information that might identify the donor. (d) Record retention requirements. (1) You must maintain documentation of: (i) Results and interpretation of all testing for relevant communicable disease agents in compliance with §§ … | |||
| 21:21:8.0.1.5.59.3.1.5 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete? | FDA | (a) Quarantine. You must keep an HCT/P in quarantine, as defined in § 1271.3(q), until completion of the donor-eligibility determination required by § 1271.50. You must quarantine semen from anonymous donors until the retesting required under § 1271.85(d) is complete. (b) Identification of HCT/Ps in quarantine. You must clearly identify as quarantined an HCT/P that is in quarantine pending completion of a donor-eligibility determination. The quarantined HCT/P must be easily distinguishable from HCT/Ps that are available for release and distribution. (c) Shipping of HCT/Ps in quarantine. If you ship an HCT/P before completion of the donor-eligibility determination, you must keep it in quarantine during shipment. The HCT/P must be accompanied by records: (1) Identifying the donor (e.g., by a distinct identification code affixed to the HCT/P container); (2) Stating that the donor-eligibility determination has not been completed; and (3) Stating that the product must not be implanted, transplanted, infused, or transferred until completion of the donor-eligibility determination, except under the terms of paragraph (d) of this section. (d) Use in cases of urgent medical need. (1) This subpart C does not prohibit the implantation, transplantation, infusion, or transfer of an HCT/P from a donor for whom the donor-eligibility determination is not complete if there is a documented urgent medical need for the HCT/P, as defined in § 1271.3(u). (2) If you make an HCT/P available for use under the provisions of paragraph (d)(1) of this section, you must prominently label it “NOT EVALUATED FOR INFECTIOUS SUBSTANCES,” and “ WARNING: Advise patient of communicable disease risks.” The following information must accompany the HCT/P: (i) The results of any donor screening required under § 1271.75 that has been completed; (ii) The results of any testing required under § 1271.80 or 1271.85 that has been completed; and (iii) A list of any screening or testing required under § 1271.75, 1271.80 or 1271.85 that has not y… | ||||
| 21:21:8.0.1.5.59.3.1.6 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited? | FDA | (a) Storage. If you are the establishment that stores the HCT/P, you must store or identify HCT/Ps from donors who have been determined to be ineligible in a physically separate area clearly identified for such use, or follow other procedures, such as automated designation, that are adequate to prevent improper release until destruction or other disposition of the HCT/P in accordance with paragraph (b) or (c) of this section. (b) Limited uses of HCT/P from ineligible donor. (1) An HCT/P from a donor who has been determined to be ineligible, based on the results of required testing and/or screening, is not prohibited by subpart C of this part from use for implantation, transplantation, infusion, or transfer under the following circumstances: (i) The HCT/P is for allogeneic use in a first-degree or second-degree blood relative; (ii) The HCT/P consists of reproductive cells or tissue from a directed reproductive donor, as defined in § 1271.3(l); or (iii) There is a documented urgent medical need as defined in § 1271.3(u). (2) You must prominently label an HCT/P made available for use under the provisions of paragraph (b)(1) of this section with the Biohazard legend shown in § 1271.3(h) with the statement “WARNING: Advise patient of communicable disease risks,” and, in the case of reactive test results, “WARNING: Reactive test results for (name of disease agent or disease).” The HCT/P must be accompanied by the records required under § 1271.55. (3) If you are the establishment that manufactured an HCT/P used under the provisions of paragraph (b)(1) of this section, you must document that you notified the physician using the HCT/P of the results of testing and screening. (c) Nonclinical use. You may make available for nonclinical purposes an HCT/P from a donor who has been determined to be ineligible, based on the results of required testing and/or screening, provided that it is labeled: (1) “For Nonclinical Use Only” and (2) With the Biohazard legend shown in § 1271.3(h). | ||||
| 21:21:8.0.1.5.59.3.1.7 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.75 How do I screen a donor? | FDA | [66 FR 5466, Jan. 19, 2001, as amended at 71 FR 14798, Mar. 24, 2006] | (a) All donors. Except as provided under § 1271.90, if you are the establishment that performs donor screening, you must screen a donor of cells or tissue by reviewing the donor's relevant medical records for: (1) Risk factors for, and clinical evidence of, relevant communicable disease agents and diseases, including: (i) Human immunodeficiency virus; (ii) Hepatitis B virus; (iii) Hepatitis C virus; (iv) Human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease; (v) Treponema pallidum ; and (2) Communicable disease risks associated with xenotransplantation. (b) Donors of viable, leukocyte-rich cells or tissue. In addition to the relevant communicable disease agents and diseases for which screening is required under paragraph (a) of this section, and except as provided under § 1271.90, you must screen the donor of viable, leukocyte-rich cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of relevant cell-associated communicable disease agents and diseases, including Human T-lymphotropic virus. (c) Donors of reproductive cells or tissue. In addition to the relevant communicable disease agents and diseases for which screening is required under paragraphs (a) and (b) of this section, as applicable, and except as provided under § 1271.90, you must screen the donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of infection due to relevant communicable diseases of the genitourinary tract. Such screening must include screening for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section. However, if the reproductive cells or tissues are recovered by a method that ensures freedom from contamination of the cells or tissue by infectious disease organisms that may be present in the genitourinary tract, then screening for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section is not required… | |||
| 21:21:8.0.1.5.59.3.1.8 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.80 What are the general requirements for donor testing? | FDA | [69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005] | (a) Testing for relevant communicable diseases is required. To adequately and appropriately reduce the risk of transmission of relevant communicable diseases, and except as provided under § 1271.90, if you are the establishment that performs donor testing, you must test a donor specimen for evidence of infection due to communicable disease agents in accordance with paragraph (c) of this section. You must test for those communicable disease agents specified in § 1271.85. In the case of a donor 1 month of age or younger, you must test a specimen from the birth mother instead of a specimen from the donor. (b) Timing of specimen collection. You must collect the donor specimen for testing at the time of recovery of cells or tissue from the donor; or up to 7 days before or after recovery, except: (1) For donors of peripheral blood stem/progenitor cells, bone marrow (if not excepted under § 1271.3(d)(4)), or oocytes, you may collect the donor specimen for testing up to 30 days before recovery; or (2) In the case of a repeat semen donor from whom a specimen has already been collected and tested, and for whom retesting is required under § 1271.85(d), you are not required to collect a donor specimen at the time of each donation. (c) Tests. You must test using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases; however, until such time as appropriate FDA-licensed, approved, or cleared donor screening tests for Chlamydia trachomatis and for Neisseria gonorrhea are available, you must use FDA-licensed, approved, or cleared tests labeled for the detection of those organisms in an asymptomatic, low-prevalence population. You must use a test specifically labeled for cadaveric specimens instead of a more generally labeled test when applicable and when available. Required testing under this section must be performed by a laboratory t… | |||
| 21:21:8.0.1.5.59.3.1.9 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | C | Subpart C—Donor Eligibility | § 1271.85 What donor testing is required for different types of cells and tissues? | FDA | (a) All donors. To adequately and appropriately reduce the risk of transmission of relevant communicable diseases, and except as provided under § 1271.90, you must test a specimen from the donor of cells or tissue, whether viable or nonviable, for evidence of infection due to relevant communicable disease agents, including: (1) Human immunodeficiency virus, type 1; (2) Human immunodeficiency virus, type 2; (3) Hepatitis B virus; (4) Hepatitis C virus; and (5) Treponema pallidum. (b) Donors of viable, leukocyte-rich cells or tissue. In addition to the relevant communicable disease agents for which testing is required under paragraph (a) of this section, and except as provided under § 1271.90, (1) You must test a specimen from the donor of viable, leukocyte-rich cells or tissue to adequately and appropriately reduce the risk of transmission of relevant cell-associated communicable diseases, including: (i) Human T-lymphotropic virus, type I; and (ii) Human T-lymphotropic virus, type II. (2) You must test a specimen from the donor of viable, leukocyte-rich cells or tissue for evidence of infection due to cytomegalovirus (CMV), to adequately and appropriately reduce the risk of transmission. You must establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for CMV. (c) Donors of reproductive cells or tissue. In addition to the communicable disease agents for which testing is required under paragraphs (a) and (b) of this section, as applicable, and except as provided under § 1271.90, you must test a specimen from the donor of reproductive cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract. Such testing must include testing for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section. However, if the reproductive cells or tissues are recovered by a method that ensures freedom from contamination of the cell… | ||||
| 21:21:8.0.1.5.59.4.1.1 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.145 Prevention of the introduction, transmission, or spread of communicable diseases. | FDA | You must recover, process, store, label, package, and distribute HCT/Ps, and screen and test cell and tissue donors, in a way that prevents the introduction, transmission, or spread of communicable diseases. | ||||
| 21:21:8.0.1.5.59.4.1.10 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.210 Supplies and reagents. | FDA | (a) Verification. You must not use supplies and reagents until they have been verified to meet specifications designed to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases. Verification may be accomplished by the establishment that uses the supply or reagent, or by the vendor of the supply or reagent. (b) Reagents. Reagents used in processing and preservation of HCT/Ps must be sterile, where appropriate. (c) In-house reagents. You must validate and/or verify the processes used for production of in-house reagents. (d) Records. You must maintain the following records pertaining to supplies and reagents: (1) Records of the receipt of each supply or reagent, including the type, quantity, manufacturer, lot number, date of receipt, and expiration date; (2) Records of the verification of each supply or reagent, including test results or, in the case of vendor verification, a certificate of analysis from the vendor; and (3) Records of the lot of supply or reagent used in the manufacture of each HCT/P. | ||||
| 21:21:8.0.1.5.59.4.1.11 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.215 Recovery. | FDA | If you are an establishment that recovers HCT/Ps, you must recover each HCT/P in a way that does not cause contamination or cross-contamination during recovery, or otherwise increase the risk of the introduction, transmission, or spread of communicable disease through the use of the HCT/P. | ||||
| 21:21:8.0.1.5.59.4.1.12 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.220 Processing and process controls. | FDA | (a) General. If you are an establishment that processes HCT/Ps, you must process each HCT/P in a way that does not cause contamination or cross-contamination during processing, and that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P. (b) Pooling. Human cells or tissue from two or more donors must not be pooled (placed in physical contact or mixed in a single receptacle) during manufacturing. (c) In-process control and testing. You must ensure that specified requirements, consistent with paragraph (a) of this section, for in-process controls are met, and that each in-process HCT/P is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received and documented. Sampling of in-process HCT/Ps must be representative of the material to be evaluated. (d) Dura mater. (1) When there is a published validated process that reduces the risk of transmissible spongiform encephalopathy, you must use this process for dura mater (or an equivalent process that you have validated), unless following this process adversely affects the clinical utility of the dura mater. (2) When you use a published validated process, you must verify such a process in your establishment. | ||||
| 21:21:8.0.1.5.59.4.1.13 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.225 Process changes. | FDA | Any change to a process must be verified or validated in accordance with § 1271.230, to ensure that the change does not create an adverse impact elsewhere in the operation, and must be approved before implementation by a responsible person with appropriate knowledge and background. You must communicate approved changes to the appropriate personnel in a timely manner. | ||||
| 21:21:8.0.1.5.59.4.1.14 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.230 Process validation. | FDA | (a) General. Where the results of processing described in § 1271.220 cannot be fully verified by subsequent inspection and tests, you must validate and approve the process according to established procedures. The validation activities and results must be documented, including the date and signature of the individual(s) approving the validation. (b) Written representation. Any written representation that your processing methods reduce the risk of transmission of communicable disease by an HCT/P, including but not limited to, a representation of sterility or pathogen inactivation of an HCT/P, must be based on a fully verified or validated process. (c) Changes. When changes to a validated process subject to paragraph (a) of this section occur, you must review and evaluate the process and perform revalidation where appropriate. You must document these activities. | ||||
| 21:21:8.0.1.5.59.4.1.15 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.250 Labeling controls. | FDA | (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design these procedures to ensure proper HCT/P identification and to prevent mix-ups. (b) Verification. Procedures must include verification of label accuracy, legibility, and integrity. (c) Labeling requirements. Procedures must ensure that each HCT/P is labeled in accordance with all applicable labeling requirements, including those in §§ 1271.55, 1271.60, 1271.65, 1271.90, 1271.290, and 1271.370, and that each HCT/P made available for distribution is accompanied by documentation of the donor eligibility determination as required under § 1271.55. | ||||
| 21:21:8.0.1.5.59.4.1.16 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.260 Storage. | FDA | (a) Control of storage areas. You must control your storage areas and stock rooms to prevent: (1) Mix-ups, contamination, and cross-contamination of HCT/Ps, supplies, and reagents, and (2) An HCT/P from being improperly made available for distribution. (b) Temperature. You must store HCT/Ps at an appropriate temperature. (c) Expiration date. Where appropriate, you must assign an expiration date to each HCT/P based on the following factors: (1) HCT/P type; (2) Processing, including the method of preservation; (3) Storage conditions; and (4) Packaging. (d) Corrective action. You must take and document corrective action whenever proper storage conditions are not met. (e) Acceptable temperature limits. You must establish acceptable temperature limits for storage of HCT/Ps at each step of the manufacturing process to inhibit the growth of infectious agents. You must maintain and record storage temperatures for HCT/Ps. You must periodically review recorded temperatures to ensure that temperatures have been within acceptable limits. | ||||
| 21:21:8.0.1.5.59.4.1.17 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P. | FDA | (a) Receipt. You must evaluate each incoming HCT/P for the presence and significance of microorganisms and inspect for damage and contamination. You must determine whether to accept, reject, or place in quarantine each incoming HCT/P, based upon pre-established criteria designed to prevent communicable disease transmission. (b) Predistribution shipment. If you ship an HCT/P within your establishment or between establishments (e.g., procurer to processor) and the HCT/P is not available for distribution as described in paragraph (c) of this section, you must first determine and document whether pre-established criteria designed to prevent communicable disease transmission have been met, and you must ship the HCT/P in quarantine. (c) Availability for distribution. (1) Before making an HCT/P available for distribution, you must review manufacturing and tracking records pertaining to the HCT/P, and, on the basis of that record review, you must verify and document that the release criteria have been met. A responsible person must document and date the determination that an HCT/P is available for distribution. (2) You must not make available for distribution an HCT/P that is in quarantine, is contaminated, is recovered from a donor who has been determined to be ineligible or for whom a donor-eligibility determination has not been completed (except as provided under §§ 1271.60, 1271.65, and 1271.90), or that otherwise does not meet release criteria designed to prevent communicable disease transmission. (3) You must not make available for distribution any HCT/P manufactured under a departure from a procedure relevant to preventing risks of communicable disease transmission, unless a responsible person has determined that the departure does not increase the risk of communicable disease through the use of the HCT/P. You must record and justify any departure from a procedure at the time of its occurrence. (d) Packaging and shipping. Packaging and shipping containers must be designed and constructed to protect th… | ||||
| 21:21:8.0.1.5.59.4.1.18 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.270 Records. | FDA | (a) General. You must maintain records concurrently with the performance of each step required in this subpart and subpart C of this part. Any requirement in this part that an action be documented involves the creation of a record, which is subject to the requirements of this section. All records must be accurate, indelible, and legible. The records must identify the person performing the work and the dates of the various entries, and must be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular HCT/P involved. (b) Records management system. You must establish and maintain a records management system relating to core CGTP requirements. Under this system, records pertaining to a particular HCT/P must be maintained in such a way as to facilitate review of the HCT/Ps history before making it available for distribution and, if necessary, subsequent to the HCT/Ps release as part of a followup evaluation or investigation. Records pertinent to the manufacture of HCT/Ps (e.g., labeling and packaging procedures, and equipment logs) must also be maintained and organized under the records management system. If records are maintained in more than one location, then the records management system must be designed to ensure prompt identification, location, and retrieval of all records. (c) Methods of retention. You may maintain records required under this subpart electronically, as original paper records, or as true copies such as photocopies, microfiche, or microfilm. Equipment that is necessary to make the records available and legible, such as computer and reader equipment, must be readily available. Records stored in electronic systems must be backed up. (d) Length of retention. You must retain all records for 10 years after their creation, unless stated otherwise in this part. However, you must retain the records pertaining to a particular HCT/P at least 10 years after the date of its administration, or if the date of administration is not known,… | ||||
| 21:21:8.0.1.5.59.4.1.19 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.290 Tracking. | FDA | [69 FR 68681, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005] | (a) General. If you perform any step in the manufacture of an HCT/P in which you handle the HCT/P, you must track each such HCT/P in accordance with this section, to facilitate the investigation of actual or suspected transmission of communicable disease and take appropriate and timely corrective action. (b) System of HCT/P tracking. (1) You must establish and maintain a system of HCT/P tracking that enables the tracking of all HCT/Ps from: (i) The donor to the consignee or final disposition; and (ii) The consignee or final disposition to the donor. (2) Alternatively, if you are an establishment that performs some but not all of the steps in the manufacture of an HCT/P in which you handle the HCT/P, you may participate in a system of HCT/P tracking established and maintained by another establishment responsible for other steps in the manufacture of the same HCT/P, provided that the tracking system complies with all the requirements of this section. (c) Distinct identification code. As part of your tracking system, you must ensure: That each HCT/P that you manufacture is assigned and labeled with a distinct identification code, e.g., alphanumeric, that relates the HCT/P to the donor and to all records pertaining to the HCT/P; and that labeling includes information designed to facilitate effective tracking, using the distinct identification code, from the donor to the recipient and from the recipient to the donor. Except as described in § 1271.55(a)(1), you must create such a code specifically for tracking, and it may not include an individual's name, social security number, or medical record number. You may adopt a distinct identification code assigned by another establishment engaged in the manufacturing process, or you may assign a new code. If you assign a new code to an HCT/P, you must establish and maintain procedures for relating the new code to the old code. (d) Tracking from consignee to donor. As part of your tracking system, you must establish and maintain a method for recording the distinc… | |||
| 21:21:8.0.1.5.59.4.1.2 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.150 Current good tissue practice requirements. | FDA | (a) General. This subpart D and subpart C of this part set forth current good tissue practice (CGTP) requirements. You must follow CGTP requirements to prevent the introduction, transmission, or spread of communicable diseases by HCT/Ps (e.g., by ensuring that the HCT/Ps do not contain communicable disease agents, that they are not contaminated, and that they do not become contaminated during manufacturing). Communicable diseases include, but are not limited to, those transmitted by viruses, bacteria, fungi, parasites, and transmissible spongiform encephalopathy agents. CGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, including but not limited to all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution. The CGTP provisions specifically governing determinations of donor eligibility, including donor screening and testing, are set out separately in subpart C of this part. (b) Core CGTP requirements. The following are core CGTP requirements: (1) Requirements relating to facilities in § 1271.190(a) and (b); (2) Requirements relating to environmental control in § 1271.195(a); (3) Requirements relating to equipment in § 1271.200(a); (4) Requirements relating to supplies and reagents in § 1271.210(a) and (b); (5) Requirements relating to recovery in § 1271.215; (6) Requirements relating to processing and process controls in § 1271.220; (7) Requirements relating to labeling controls in § 1271.250(a) and (b); (8) Requirements relating to storage in § 1271.260 (a) through (d); (9) Requirements relating to receipt, predistribution shipment, and distribution of an HCT/P in § 1271.265(a) through (d); and (10) Requirements relating to donor eligibility determinations, donor screening, and donor testing in §§ 1271.50, 1271.75, 1271.80, and 1271.85. (c) Compliance with applicable requirements —(1) Manufacturing arrangements (i) If you are an establishment that engages in only some operation… | ||||
| 21:21:8.0.1.5.59.4.1.20 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.320 Complaint file. | FDA | (a) Procedures. You must establish and maintain procedures for the review, evaluation, and documentation of complaints as defined in § 1271.3(aa), relating to core current good tissue practice (CGTP) requirements, and the investigation of complaints as appropriate. (b) Complaint file. You must maintain a record of complaints that you receive in a file designated for complaints. The complaint file must contain sufficient information about each complaint for proper review and evaluation of the complaint (including the distinct identification code of the HCT/P that is the subject of the complaint) and for determining whether the complaint is an isolated event or represents a trend. You must make the complaint file available for review and copying upon request from FDA. (c) Review and evaluation of complaints. You must review and evaluate each complaint relating to core CGTP requirements to determine if the complaint is related to an HCT/P deviation or to an adverse reaction, and to determine if a report under § 1271.350 or another applicable regulation is required. As soon as practical, you must review, evaluate, and investigate each complaint that represents an event required to be reported to FDA, as described in § 1271.350. You must review and evaluate a complaint relating to core CGTP requirements that does not represent an event required to be reported to determine whether an investigation is necessary; an investigation may include referring a copy of the complaint to another establishment that performed manufacturing steps pertinent to the complaint. When no investigation is made, you must maintain a record that includes the reason no investigation was made, and the name of the individual(s) responsible for the decision not to investigate. | ||||
| 21:21:8.0.1.5.59.4.1.3 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.155 Exemptions and alternatives. | FDA | (a) General. You may request an exemption from or alternative to any requirement in subpart C or D of this part. (b) Request for exemption or alternative. Submit your request under this section to the Director of the appropriate Center (the Director), e.g., the Center for Biologics Evaluation and Research or the Center for Devices and Radiological Health. The request must be accompanied by supporting documentation, including all relevant valid scientific data, and must contain either: (1) Information justifying the requested exemption from the requirement, or (2) A description of a proposed alternative method of meeting the requirement. (c) Criteria for granting an exemption or alternative. The Director may grant an exemption or alternative if he or she finds that such action is consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable diseases and that: (1) The information submitted justifies an exemption; or (2) The proposed alternative satisfies the purpose of the requirement. (d) Form of request. You must ordinarily make your request for an exemption or alternative in writing (hard copy or electronically). However, if circumstances make it difficult (e.g., there is inadequate time) to submit your request in writing, you may make the request orally, and the Director may orally grant an exemption or alternative. You must follow your oral request with an immediate written request, to which the Director will respond in writing. (e) Operation under exemption or alternative. You must not begin operating under the terms of a requested exemption or alternative until the exemption or alternative has been granted. You may apply for an extension of an exemption or alternative beyond its expiration date, if any. (f) Documentation. If you operate under the terms of an exemption or alternative, you must maintain documentation of: (1) FDA's grant of the exemption or alternative, and (2) The date on which you began operating un… | ||||
| 21:21:8.0.1.5.59.4.1.4 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.160 Establishment and maintenance of a quality program. | FDA | (a) General. If you are an establishment that performs any step in the manufacture of HCT/Ps, you must establish and maintain a quality program intended to prevent the introduction, transmission, or spread of communicable diseases through the manufacture and use of HCT/Ps. The quality program must be appropriate for the specific HCT/Ps manufactured and the manufacturing steps performed. The quality program must address all core CGTP requirements listed in § 1271.150(b). (b) Functions. Functions of the quality program must include: (1) Establishing and maintaining appropriate procedures relating to core CGTP requirements, and ensuring compliance with the requirements of § 1271.180 with respect to such procedures, including review, approval, and revision; (2) Ensuring that procedures exist for receiving, investigating, evaluating, and documenting information relating to core CGTP requirements, including complaints, and for sharing any information pertaining to the possible contamination of the HCT/P or the potential for transmission of a communicable disease by the HCT/P with the following: (i) Other establishments that are known to have recovered HCT/Ps from the same donor; (ii) Other establishments that are known to have performed manufacturing steps with respect to the same HCT/P; and (iii) Relating to consignees, in the case of such information received after the HCT/P is made available for distribution, shipped to the consignee, or administered to the recipient, procedures must include provisions for assessing risk and appropriate followup, and evaluating the effect this information has on the HCT/P and for the notification of all entities to whom the affected HCT/P was distributed, the quarantine and recall of the HCT/P, and/or reporting to FDA, as necessary. (3) Ensuring that appropriate corrective actions relating to core CGTP requirements, including reaudits of deficiencies, are taken and documented, as necessary. You must verify corrective actions to ensure that such actions are effective and a… | ||||
| 21:21:8.0.1.5.59.4.1.5 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.170 Personnel. | FDA | (a) General. You must have personnel sufficient to ensure compliance with the requirements of this part. (b) Competent performance of functions. You must have personnel with the necessary education, experience, and training to ensure competent performance of their assigned functions. Personnel must perform only those activities for which they are qualified and authorized. (c) Training. You must train all personnel, and retrain as necessary, to perform their assigned responsibilities adequately. | ||||
| 21:21:8.0.1.5.59.4.1.6 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.180 Procedures. | FDA | (a) General. You must establish and maintain procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps. You must design these procedures to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases through the use of HCT/Ps. (b) Review and approval. Before implementation, a responsible person must review and approve these procedures. (c) Availability. These procedures must be readily available to the personnel in the area where the operations to which they relate are performed, or in a nearby area if such availability is impractical. (d) Standard procedures. If you adopt current standard procedures from another organization, you must verify that the procedures meet the requirements of this part and are appropriate for your operations. | ||||
| 21:21:8.0.1.5.59.4.1.7 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.190 Facilities. | FDA | (a) General. Any facility used in the manufacture of HCT/Ps must be of suitable size, construction, and location to prevent contamination of HCT/Ps with communicable disease agents and to ensure orderly handling of HCT/Ps without mix-ups. You must maintain the facility in a good state of repair. You must provide lighting, ventilation, plumbing, drainage, and access to sinks and toilets that are adequate to prevent the introduction, transmission, or spread of communicable disease. (b) Facility cleaning and sanitation. (1) You must maintain any facility used in the manufacture of HCT/Ps in a clean, sanitary, and orderly manner, to prevent the introduction, transmission, or spread of communicable disease. (2) You must dispose of sewage, trash, and other refuse in a timely, safe, and sanitary manner. (c) Operations. You must divide a facility used in the manufacture of HCT/Ps into separate or defined areas of adequate size for each operation that takes place in the facility, or you must establish and maintain other control systems to prevent improper labeling, mix-ups, contamination, cross-contamination, and accidental exposure of HCT/Ps to communicable disease agents. (d) Procedures and records. (1) You must establish and maintain procedures for facility cleaning and sanitation for the purpose of preventing the introduction, transmission, or spread of communicable disease. These procedures must assign responsibility for sanitation and must describe in sufficient detail the cleaning methods to be used and the schedule for cleaning the facility. (2) You must document, and maintain records of, all cleaning and sanitation activities performed to prevent contamination of HCT/Ps. You must retain such records 3 years after their creation. | ||||
| 21:21:8.0.1.5.59.4.1.8 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.195 Environmental control and monitoring. | FDA | (a) Environmental control. Where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents, you must adequately control environmental conditions and provide proper conditions for operations. Where appropriate, you must provide for the following control activities or systems: (1) Temperature and humidity controls; (2) Ventilation and air filtration; (3) Cleaning and disinfecting of rooms and equipment to ensure aseptic processing operations; and (4) Maintenance of equipment used to control conditions necessary for aseptic processing operations. (b) Inspections. You must inspect each environmental control system periodically to verify that the system, including necessary equipment, is adequate and functioning properly. You must take appropriate corrective action as necessary. (c) Environmental monitoring. You must monitor environmental conditions where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents. Where appropriate, you must provide environmental monitoring for microorganisms. (d) Records. You must document, and maintain records of, environmental control and monitoring activities. | ||||
| 21:21:8.0.1.5.59.4.1.9 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | D | Subpart D—Current Good Tissue Practice | § 1271.200 Equipment. | FDA | (a) General. To prevent the introduction, transmission, or spread of communicable diseases, equipment used in the manufacture of HCT/Ps must be of appropriate design for its use and must be suitably located and installed to facilitate operations, including cleaning and maintenance. Any automated, mechanical, electronic, or other equipment used for inspection, measuring, or testing in accordance with this part must be capable of producing valid results. You must clean, sanitize, and maintain equipment according to established schedules. (b) Procedures and schedules. You must establish and maintain procedures for cleaning, sanitizing, and maintaining equipment to prevent malfunctions, contamination or cross-contamination, accidental exposure of HCT/Ps to communicable disease agents, and other events that could reasonably be expected to result in the introduction, transmission, or spread of communicable diseases. (c) Calibration of equipment. Where appropriate, you must routinely calibrate according to established procedures and schedules all automated, mechanical, electronic, or other equipment used for inspection, measuring, and testing in accordance with this part. (d) Inspections. You must routinely inspect equipment for cleanliness, sanitation, and calibration, and to ensure adherence to applicable equipment maintenance schedules. (e) Records. You must document and maintain records of all equipment maintenance, cleaning, sanitizing, calibration, and other activities performed in accordance with this section. You must display records of recent maintenance, cleaning, sanitizing, calibration, and other activities on or near each piece of equipment, or make the records readily available to the individuals responsible for performing these activities and to the personnel using the equipment. You must maintain records of the use of each piece of equipment, including the identification of each HCT/P manufactured with that equipment. | ||||
| 21:21:8.0.1.5.59.5.1.1 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | E | Subpart E—Additional Requirements for Establishments Described in § 1271.10 | § 1271.330 Applicability. | FDA | The provisions set forth in this subpart are being implemented for nonreproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the Public Health Service Act and the regulations in this part, and for the establishments that manufacture those HCT/Ps. HCT/Ps that are drugs or devices regulated under the act, or are biological products regulated under section 351 of the Public Health Service Act, are not subject to the regulations set forth in this subpart. | ||||
| 21:21:8.0.1.5.59.5.1.2 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | E | Subpart E—Additional Requirements for Establishments Described in § 1271.10 | § 1271.350 Reporting. | FDA | [69 FR 68686, Nov. 24, 2004, as amended at 80 FR 18095, Apr. 3, 2015] | (a) Adverse reaction reports. (1) You must investigate any adverse reaction involving a communicable disease related to an HCT/P that you made available for distribution. You must report to FDA an adverse reaction involving a communicable disease if it: (i) Is fatal; (ii) Is life-threatening; (iii) Results in permanent impairment of a body function or permanent damage to body structure; or (iv) Necessitates medical or surgical intervention, including hospitalization. (2) You must submit each report on a Form FDA-3500A to the address in paragraph (a)(5) of this section within 15 calendar days of initial receipt of the information. (3) You must, as soon as practical, investigate all adverse reactions that are the subject of these 15-day reports and must submit followup reports within 15 calendar days of the receipt of new information or as requested by FDA. If additional information is not obtainable, a followup report may be required that describes briefly the steps taken to seek additional information and the reasons why it could not be obtained. (4) You may obtain copies of the reporting form (FDA-3500A) from the Center for Biologics Evaluation and Research (see address in paragraph (a)(5) of this section). Electronic Form FDA-3500A may be obtained at http://www.fda.gov/medwatch or at http://www.hhs.gov/forms. (5) You must submit two copies of each report described in this paragraph to the Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002. FDA may waive the requirement for the second copy in appropriate circumstances. (b) Reports of HCT/P deviations. (1) You must investigate all HCT/P deviations related to a distributed HCT/P for which you performed a manufacturing step. (2) You must report any such HCT/P deviation relating to the core CGTP requirements, if the HCT/P deviation occurred in your facility or in a facility that performed a manufacturing step for you under con… | |||
| 21:21:8.0.1.5.59.5.1.3 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | E | Subpart E—Additional Requirements for Establishments Described in § 1271.10 | § 1271.370 Labeling. | FDA | [69 FR 68686, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005; 81 FR 40518, June 22, 2016] | The following requirements apply in addition to §§ 1271.55, 1271.60, 1271.65, and 1271.90: (a) You must label each HCT/P made available for distribution clearly and accurately. (b) The following information must appear on the HCT/P label: (1) Distinct identification code affixed to the HCT/P container, and assigned in accordance with § 1271.290(c); (2) Description of the type of HCT/P; (3) Expiration date, if any; and (4) Warnings required under § 1271.60(d)(2), § 1271.65(b)(2), or § 1271.90(c), if applicable and physically possible. If it is not physically possible to include these warnings on the label, the warnings must, instead, accompany the HCT/P. (c) The following information must either appear on the HCT/P label or accompany the HCT/P: (1) Name and address of the establishment that determines that the HCT/P meets release criteria and makes the HCT/P available for distribution; (2) Storage temperature; (3) Other warnings, where appropriate; and (4) Instructions for use when related to the prevention of the introduction, transmission, or spread of communicable diseases. | |||
| 21:21:8.0.1.5.59.6.1.1 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | F | Subpart F—Inspection and Enforcement of Establishments Described in § 1271.10 | § 1271.390 Applicability. | FDA | The provisions set forth in this subpart are applicable only to HCT/Ps described in § 1271.10 and regulated solely under section 361 of the Public Health Service Act and the regulations in this part, and to the establishments that manufacture those HCT/Ps. HCT/Ps that are drugs or devices regulated under the act, or are biological products regulated under section 351 of the Public Health Service Act, are not subject to the regulations set forth in this subpart. | ||||
| 21:21:8.0.1.5.59.6.1.2 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | F | Subpart F—Inspection and Enforcement of Establishments Described in § 1271.10 | § 1271.400 Inspections. | FDA | (a) If you are an establishment that manufactures HCT/Ps described in § 1271.10, whether or not under contract, you must permit the Food and Drug Administration (FDA) to inspect any manufacturing location at any reasonable time and in a reasonable manner to determine compliance with applicable provisions of this part. The inspection will be conducted as necessary in the judgment of the FDA and may include your establishment, facilities, equipment, finished and unfinished materials, containers, processes, HCT/Ps, procedures, labeling, records, files, papers, and controls required to be maintained under the part. The inspection may be made with or without prior notification and will ordinarily be made during regular business hours. (b) The frequency of inspection will be at the agency's discretion. (c) FDA will call upon the most responsible person available at the time of the inspection of the establishment and may question the personnel of the establishment as necessary to determine compliance with the provisions of this part. (d) FDA's representatives may take samples, may review and copy any records required to be kept under this part, and may use other appropriate means to record evidence of observations during inspections conducted under this subpart. (e) The public disclosure of records containing the name or other positive identification of donors or recipients of HCT/Ps will be handled in accordance with FDA's procedures on disclosure of information as set forth in parts 20 and 21 of this chapter. | ||||
| 21:21:8.0.1.5.59.6.1.3 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | F | Subpart F—Inspection and Enforcement of Establishments Described in § 1271.10 | § 1271.420 HCT/Ps offered for import. | FDA | [69 FR 68687, Nov. 24, 2004, as amended at 81 FR 85873, Nov. 29, 2016] | (a) Except as provided in paragraphs (c) and (d) of this section, when an HCT/P is offered for import, the importer of record must notify, either before or at the time of importation, the director of the district of the Food and Drug Administration (FDA) having jurisdiction over the port of entry through which the HCT/P is imported or offered for import, or such officer of the district as the director may designate to act in his or her behalf in administering and enforcing this part, and must provide sufficient information, including information submitted in the Automated Commercial Environment (ACE) system or any other electronic data interchange system authorized by the U.S. Customs and Border Protection Agency as required in part 1, subpart D of this chapter, for FDA to make an admissibility decision. (b) Except as provided in paragraphs (c) and (d) of this section, an HCT/P offered for import must be held intact by the importer or consignee, under conditions necessary to prevent transmission of communicable disease, until an admissibility decision is made by FDA. The HCT/P may be transported under quarantine to the consignee, while the FDA district reviews the documentation accompanying the HCT/P. When FDA makes a decision regarding the admissibility of the HCT/P, FDA will notify the importer of record. (c) This section does not apply to reproductive HCT/Ps regulated solely under section 361 of the Public Health Service Act and the regulations in this part, and donated by a sexually intimate partner of the recipient for reproductive use. (d) This section does not apply to peripheral blood stem/progenitor cells regulated solely under section 361 of the Public Health Service Act and the regulations in this part, except that paragraphs (a) and (b) of this section apply when circumstances occur under which such imported peripheral blood stem/progenitor cells may present an unreasonable risk of communicable disease transmission which indicates the need to review the information referenced in paragraph (a) of th… | |||
| 21:21:8.0.1.5.59.6.1.4 | 21 | Food and Drugs | I | L | 1271 | PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS | F | Subpart F—Inspection and Enforcement of Establishments Described in § 1271.10 | § 1271.440 Orders of retention, recall, destruction, and cessation of manufacturing. | FDA | (a) Upon an agency finding that there are reasonable grounds to believe that an HCT/P is a violative HCT/P because it was manufactured in violation of the regulations in this part and, therefore, the conditions of manufacture of the HCT/P do not provide adequate protections against risks of communicable disease transmission; or the HCT/P is infected or contaminated so as to be a source of dangerous infection to humans; or an establishment is in violation of the regulations in this part and, therefore, does not provide adequate protections against the risks of communicable disease transmission, the Food and Drug Administration (FDA) may take one or more of the following actions: (1) Serve upon the person who distributed the HCT/P a written order that the HCT/P be recalled and/or destroyed, as appropriate, and upon persons in possession of the HCT/P that the HCT/P must be retained until it is recalled by the distributor, destroyed, or disposed of as agreed by FDA, or the safety of the HCT/P is confirmed; (2) Take possession of and/or destroy the violative HCT/P; or (3) Serve upon the establishment an order to cease manufacturing until compliance with the regulations of this part has been achieved. When FDA determines there are reasonable grounds to believe there is a danger to health, such order will be effective immediately. In other situations, such order will be effective after one of the following events, whichever is later: (i) Passage of 5 working days from the establishment's receipt of the order; or (ii) If the establishment requests a hearing in accordance with paragraph (e) of this section and part 16 of this chapter, a decision in, and in accordance with, those proceedings. (b) A written order issued under paragraph (a) of this section will state with particularity the facts that justify the order. (c)(1) A written order issued under paragraph (a)(1) of this section will ordinarily provide that the HCT/P be recalled and/or destroyed within 5 working days from the date of receipt of the order. Afte… |
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