{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where agency = \"FDA\" and part_number = 230 sorted by section_id", "rows": [["21:21:4.0.1.1.17.1.1.1", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 230.1 Scope of this part.", "FDA", "", "", "", "This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of certifications to market designated medical gases under sections 575 and 576 of the Federal Food, Drug, and Cosmetic Act, as well as amendments and supplements to those certifications. This part also sets forth the postmarketing safety reporting requirements for designated medical gases."], ["21:21:4.0.1.1.17.1.1.2", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 230.2 Purpose.", "FDA", "", "", "", "The purpose of this part is to establish an efficient process for the certification of designated medical gases and to establish an effective system for surveillance of such gases."], ["21:21:4.0.1.1.17.1.1.3", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 230.3 Definitions.", "FDA", "", "", "", "(a) The definitions and interpretations contained in sections 201 and 575 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part.\n\n(b) The following definitions of terms apply to this part:\n\n(1)  Adverse event  means any untoward medical occurrence associated with the use of a designated medical gas in humans or animals, whether or not it is considered related to the designated medical gas. An adverse event can occur in the course of the use of a designated medical gas; from overdose of a designated medical gas, whether accidental or intentional; from abuse of a designated medical gas; from discontinuation of the designated medical gas ( e.g.,  physiological withdrawal); and it includes any failure of expected pharmacological action.\n\n(2)  Applicant  means any person who submits a certification request for a designated medical gas under this part, including a supplement, and any person who owns a granted certification for a designated medical gas under this part.\n\n(3)  Certification request  means a submission under section 576 of the Federal Food, Drug, and Cosmetic Act requesting certification of a medical gas as a designated medical gas.\n\n(4)  FDA  or  Agency  means the Food and Drug Administration.\n\n(5)  Individual case safety report  (ICSR) means a description of an adverse event related to an individual patient or subject.\n\n(6)  ICSR attachments  means documents related to the adverse event described in an ICSR, such as medical records, hospital discharge summaries, or other documentation.\n\n(7)  Life-threatening adverse event  means any adverse event that places the patient, in the view of the initial reporter, at  immediate  risk of death from the adverse event as it occurred,  i.e.,  it does not include an adverse event that, had it occurred in a more severe form, might have caused death.\n\n(8)  Minimum data set for an ICSR for an adverse event  means the minimum four elements required for reporting an ICSR of an adverse event: An identifiable patient, an identifiable reporter, a suspect designated medical gas, and an adverse event.\n\n(9)  Nonapplicant  means any person other than the applicant whose name appears on the label of a designated medical gas container as a manufacturer, packer, or distributor.\n\n(10)  Serious adverse event  means:\n\n(i) An adverse event is considered \u201cserious\u201d if it results in any of the following outcomes:\n\n(A) Death;\n\n(B) A life-threatening adverse event;\n\n(C) Inpatient hospitalization or prolongation of existing hospitalization;\n\n(D) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; and/or\n\n(E) A congenital anomaly/birth defect.\n\n(ii) Other events that may be considered serious adverse events: Important medical events that may not result in one of the listed outcomes in this definition may be considered serious adverse events when, based upon appropriate medical judgment, they may jeopardize the patient or study subject and may require medical or surgical intervention to prevent one of the outcomes listed in this paragraph (b)(10). Examples include: Allergic bronchospasm requiring intensive treatment in an emergency department or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of product dependency or product abuse. Additional examples in animals include: Severe hypersensitivity reactions or respiratory distress."], ["21:21:4.0.1.1.17.2.1.1", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "B", "Subpart B\u2014Certification of Designated Medical Gases", "", "\u00a7 230.50 General requirements for all submission types.", "FDA", "", "", "", "(a)  Who must submit a request for certification.  (1) The certification process described in this subpart applies to designated medical gases for the indications described in section 576(a)(3)(A)(i) of the Federal Food, Drug, and Cosmetic Act. Any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce shall file a request for certification. The certification process is the same for all designated medical gases, regardless of whether it is intended for human use, animal use, or both. The applicant must identify its intention to market its designated medical gas for human use, animal use, or both.\n\n(2) Any person that proposes to market a medical gas that is a new drug for human use must obtain approval under part 314 of this chapter, and any person that proposes to market a medical gas that is a new animal drug for animal use must obtain approval under part 514 of this chapter, unless\u2014\n\n(i) The medical gas meets the definition of a designated medical gas; and\n\n(ii) The medical gas is proposed to be marketed alone or in combination (as medically appropriate) with another designated medical gas or other designated medical gases, for which a certification or certifications have been granted, for a use described under section 576(a)(3)(A)(i) of the Federal Food, Drug, and Cosmetic Act.\n\n(b)  The applicant must include the following information in its certification request \u2014(1)  Applicant information.  The applicant must identify the name, address, telephone number, and email address of the person requesting certification. If the address of the person requesting certification is not in the United States, the certification request is required to contain the name and address of, and be countersigned by, an attorney, agent, or other authorized official who resides or maintains a place of business within the United States.\n\n(2)  Type of submission.  The applicant must indicate the type of submission as one of the following:\n\n(i)  Original certification request.  An initial request submitted by an applicant for certification of a medical gas as a designated medical gas.\n\n(ii)  Amendment to a pending certification request.  Any submission related to a pending submission that revises existing information or provides additional information, including responses to Information Request Letters.\n\n(iii)  Resubmission.  Any submission that has been revised and submitted again following a previous denial. If an applicant chooses to resubmit its submission, it must provide a written response to the deficiencies identified in FDA's denial letter, along with other information required for certification requests.\n\n(iv)  Supplement to a granted certification.  Any submission that contains a change to a granted certification.\n\n(v)  Other.  Any submission that does not fit in one of the other categories.\n\n(3)  Description of medical gas.  A separate certification request is required to be submitted for each designated medical gas for which certification is sought. Each designated medical gas certification request must include the name of the medical gas and a certification statement from the applicant that the designated medical gas meets the appropriate compendial standard.\n\n(4)  Facility information.  Each certification request must include the name and address of the facility or facilities where the designated medical gas will be initially produced. For each facility, include a brief description of the manufacturing or processing activities performed, the FDA Establishment Identifier, if one exists, and the Unique Facility Identifier in accordance with the requirements of part 207 of this chapter and section 510 of the Federal Food, Drug, and Cosmetic Act. For amendments and supplements, only changes to the list of facilities are required to be included.\n\n(5)  Certification of adequate manufacture, processing, packaging, and holding of designated medical gas.  The applicant must certify that the applicant's methods, facilities, and controls used for the manufacture, processing, packing, and holding of the designated medical gas, as applicable, are adequate to ensure its safety, identity, strength, quality, and purity.\n\n(6)  Additional information.  The applicant must provide any other information which FDA deems appropriate to determine whether the medical gas is a designated medical gas. The applicant may also provide other information that the applicant believes will assist FDA in evaluating the request.\n\n(c)  Where and how to submit a request for certification.  The applicant must submit a signed, completed request for certification form either in an electronic format that FDA can process, review, and archive, or in hard copy by submitting two paper copies to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705."], ["21:21:4.0.1.1.17.2.1.2", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "B", "Subpart B\u2014Certification of Designated Medical Gases", "", "\u00a7 230.65 Withdrawal by the applicant of a certification request before it is deemed granted.", "FDA", "", "", "", "An applicant may at any time withdraw a certification request that is not yet deemed granted by notifying FDA in writing. A decision to withdraw the certification request is without prejudice to refiling. The Agency will retain the certification request and will provide a copy to the applicant on request under the fee schedule in \u00a7 20.45 of this chapter (FDA's public information regulations)."], ["21:21:4.0.1.1.17.2.1.3", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "B", "Subpart B\u2014Certification of Designated Medical Gases", "", "\u00a7 230.70 Supplements and other changes to a granted certification.", "FDA", "", "", "", "(a) The applicant must submit a supplement if any information in the certification request changes after the request has been deemed granted, including, but not limited to, the addition of a new facility manufacturing the designated medical gas, a change in contact information, or a change in the corporate name.\n\n(b) Each supplement must include a signed, completed request for certification form with the updated information in accordance with \u00a7 230.50. The updated information must be submitted no later than 30 calendar days after the date the change occurred."], ["21:21:4.0.1.1.17.2.1.4", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "B", "Subpart B\u2014Certification of Designated Medical Gases", "", "\u00a7 230.72 Change in ownership of a granted certification.", "FDA", "", "", "", "An applicant may transfer ownership of its certification. At the time of transfer the new and former owners are required to submit information to FDA as follows:\n\n(a) The former owner must submit a letter or other document that states that all rights to the certification have been transferred to the new owner.\n\n(b) The new owner must submit a supplement under \u00a7 230.70 signed by the new owner describing any changes in the conditions in the granted certification and a letter or other document containing the date that the change in ownership is effective."], ["21:21:4.0.1.1.17.2.1.5", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "B", "Subpart B\u2014Certification of Designated Medical Gases", "", "\u00a7 230.80 Annual report.", "FDA", "", "", "", "(a) The applicant must submit each year within 60 calendar days of the new calendar year an annual report containing the information described in paragraph (b) of this section. The applicant must submit a signed, completed annual report form either in an electronic format that FDA can process, review, and archive, or in hard copy by submitting two paper copies to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705.\n\n(b) The report must contain, for the prior calendar year, the following information in the order listed:\n\n(1)  Summary.  A brief summary of significant new information that might affect the safety, effectiveness, or labeling of the designated medical gas, including any actions the applicant has taken or intends to take as a result of this new information.\n\n(2)  Distribution data.  Information about the quantity of the designated medical gas distributed by the applicant. The information must include the National Drug Code (NDC) numbers, the quantities distributed for domestic use, and the quantities distributed for foreign use. Disclosure of financial or pricing data is not required.\n\n(3)  Administrative changes.  Any changes to the applicant's name or contact information.\n\n(4)  Current facilities.  A list of current facilities where the designated medical gas is initially produced, and a list of facilities that are no longer in use."], ["21:21:4.0.1.1.17.2.1.6", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "B", "Subpart B\u2014Certification of Designated Medical Gases", "", "\u00a7 230.100 FDA review of submissions.", "FDA", "", "", "", "(a) In reviewing a submission pursuant to \u00a7 230.50, FDA will consider information provided with the submission along with any other available, relevant information of which FDA becomes aware, including information obtained from State or Federal officials, FDA inspection reports, or any other source.\n\n(b) FDA will deny a submission if FDA finds that:\n\n(1) The medical gas that is the subject of the submission is not a designated medical gas;\n\n(2) The submission does not contain the required information or otherwise appears to lack sufficient information to determine that the medical gas is a designated medical gas;\n\n(3) The applicant's methods, facilities, and controls used for the manufacture, processing, and handling of the designated medical gas, as applicable, are not adequate to ensure its safety, identity, strength, quality, and purity; or\n\n(4) Denying the request is otherwise necessary to protect the public health.\n\n(c) Within 60 calendar days of filing of a submission, FDA may contact the applicant to request additional information regarding the submission if it determines that required information is not included in the submission, that FDA needs such information to determine whether the medical gas is a designated medical gas, or that FDA determines such information is necessary to protect the public health. Upon receipt of an amendment to a pending certification request, this 60-day review period will restart. If FDA is not able to contact the applicant to obtain and evaluate the information within the 60-day review period, FDA may find that the submission lacks sufficient information to permit a determination that the medical gas is a designated medical gas and deny the submission. If FDA is able to contact the applicant but is not provided with the additional information requested within the 60-day review period, FDA may find that the request lacks sufficient information to permit a determination that the medical gas is a designated medical gas and deny the submission.\n\n(d) Within 60 calendar days of filing of a submission, if FDA makes one of the findings described in paragraph (b) of this section, FDA will notify the applicant in writing that the submission is denied and provide the basis for FDA's determination."], ["21:21:4.0.1.1.17.2.1.7", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "B", "Subpart B\u2014Certification of Designated Medical Gases", "", "\u00a7 230.105 When a submission is deemed granted.", "FDA", "", "", "", "Unless FDA makes one of the findings described in \u00a7 230.100(b) and notifies the applicant within 60 calendar days of filing that the submission is denied, the certification is deemed to be granted and the designated medical gas will be deemed to have in effect an approved application under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act, or both, as applicable, for the indications described in section 576(a)(3)(A)(i) of the Federal Food, Drug, and Cosmetic Act. FDA will notify the applicant in writing."], ["21:21:4.0.1.1.17.2.1.8", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "B", "Subpart B\u2014Certification of Designated Medical Gases", "", "\u00a7 230.150 Withdrawal or revocation of approval of an application.", "FDA", "", "", "", "(a)  Withdrawal.  (1) FDA will notify the applicant, and afford an opportunity for a hearing on a proposal to withdraw approval of the application under the procedure in \u00a7 314.200 of this chapter, \u00a7 514.200 of this chapter, or both, as applicable, if any of the following apply:\n\n(i) The Secretary of Health and Human Services has suspended the approval of the application for a designated medical gas on a finding that there is an imminent hazard to the public health. FDA will promptly afford the applicant an expedited hearing following summary suspension on a finding of imminent hazard to health.\n\n(ii) FDA finds:\n\n(A) That clinical or other experience, tests, or other scientific data show that the designated medical gas is unsafe for use under the conditions of use upon the basis of which the application was approved; or\n\n(B) That new evidence of clinical experience not available to FDA until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available when the application was approved, reveal that the designated medical gas is not shown to be safe for use under the conditions of use upon the basis of which the application was approved; or\n\n(C) Upon the basis of new information before FDA with respect to the designated medical gas, evaluated together with the evidence available when the application was approved, that there is a lack of substantial evidence from adequate and well-controlled investigations as defined in \u00a7 314.126 of this chapter, that the designated medical gas will have the effect it is purported or represented to have under the conditions of use prescribed, recommended, or suggested in its labeling; or\n\n(D) That the application contains any untrue statement of a material fact.\n\n(2) FDA may notify the applicant, and afford an opportunity for a hearing on a proposal to withdraw approval of the application under the procedure in \u00a7 314.200 of this chapter, \u00a7 514.200 of this chapter, or both, as applicable, if the Agency finds:\n\n(i) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain required records or to make required reports applicable to designated medical gases, including under sections 505(k) and 512(l) of the Federal Food, Drug, and Cosmetic Act and this part, part 213 of this chapter, and \u00a7 314.81(b)(3) of this chapter, or that the applicant has refused to permit access to, or copying or verification of, its records.\n\n(ii) That on the basis of new information before FDA, evaluated together with the evidence available when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the designated medical gas are inadequate to ensure and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the Agency.\n\n(iii) That on the basis of new information before FDA, evaluated together with the evidence available when the application was approved, the labeling of the designated medical gas, based on a fair evaluation of all material facts, is false or misleading in any particular, and the labeling was not corrected by the applicant within a reasonable time after receipt of written notice from the Agency.\n\n(iv) That the applicant has failed to comply with the notice requirements of section 510(j)(2) of the Federal Food, Drug, and Cosmetic Act.\n\n(3) FDA will withdraw approval of an application if the applicant requests its withdrawal because the designated medical gas subject to the application is no longer being marketed, provided none of the conditions listed in paragraphs (a)(1) and (2) of this section applies to the designated medical gas. FDA will consider a written request for a withdrawal under this paragraph (a)(3) to be a waiver of an opportunity for hearing otherwise provided for in this section. Withdrawal of approval of an application under this paragraph (a)(3) is without prejudice to refiling.\n\n(4) FDA may notify an applicant that it believes a potential problem associated with a designated medical gas is sufficiently serious that the designated medical gas should be removed from the market and may ask the applicant to waive the opportunity for hearing otherwise provided for under this section, to permit FDA to withdraw approval of the application for the product, and to remove voluntarily the product from the market. If the applicant agrees, the Agency will not make a finding under paragraph (a)(1) or (2) of this section, but will withdraw approval of the application in a notice published in the  Federal Register  that contains a brief summary of the Agency's and the applicant's views of the reasons for withdrawal.\n\n(5) If FDA withdraws an approval, FDA will publish a notice in the  Federal Register  announcing the withdrawal of approval.\n\n(b)  Revocation.  FDA may revoke the grant of a certification if FDA determines, after providing the applicant with notice and opportunity for an informal hearing in accordance with part 16 of this chapter, that the request for certification contains any material omission or falsification."], ["21:21:4.0.1.1.17.3.1.1", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "C", "Subpart C\u2014Postmarketing Quality and Safety Reporting", "", "\u00a7 230.205 Field alert reports.", "FDA", "", "", "", "The applicant shall submit a field alert report containing all information described in paragraphs (a) and (b) of this section about distributed designated medical gases and articles to the FDA district office that is responsible for the facility involved as soon as possible but no later than 45 calendar days from the date the applicant, or its agent or contractor, obtained information suggesting that a reportable incident has occurred. If the information suggests that the reportable incident may require a rapid response to address a public health risk, the applicant must as soon as possible, but no later than 3 working days from obtaining the information, submit a field alert report. The information may be provided by telephone or other rapid communication means, with prompt written followup. The report and its mailing cover should be plainly marked: \u201cDesignated Medical Gas\u2014Field Alert Report.\u201d\n\n(a) Information concerning any incident that causes the designated medical gas or its labeling to be mistaken for, or applied to, another article.\n\n(b) Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed designated medical gas, or any failure of one or more distributed batches of the designated medical gas to meet established specifications."], ["21:21:4.0.1.1.17.3.1.2", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "C", "Subpart C\u2014Postmarketing Quality and Safety Reporting", "", "\u00a7 230.210 General reporting requirements for designated medical gas adverse events.", "FDA", "", "", "", "(a)  Review of safety information.  Each applicant and nonapplicant must promptly review all safety information that the applicant or nonapplicant receives or otherwise obtains from any source, foreign or domestic, such as information derived from commercial marketing experience, reports in the published scientific and medical literature, unpublished scientific papers, and reports from regulatory authorities.\n\n(b)  Safety reporting disclaimer.  (1) A report or information submitted by an applicant or nonapplicant (and any release by FDA of that report or information) under \u00a7 230.220 or \u00a7 230.230 does not necessarily reflect a conclusion by the applicant or nonapplicant or by FDA that the report or information constitutes an admission that the designated medical gas caused or contributed to an adverse effect.\n\n(2) An applicant or nonapplicant need not admit, and may deny, that the report or information submitted under \u00a7 230.220 or \u00a7 230.230 constitutes an admission that the designated medical gas caused or contributed to an adverse effect."], ["21:21:4.0.1.1.17.3.1.3", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "C", "Subpart C\u2014Postmarketing Quality and Safety Reporting", "", "\u00a7 230.220 Human designated medical gas ICSR requirements.", "FDA", "", "", "", "(a)  ICSR reporting \u2014(1)  General.  Except as provided in paragraph (c) of this section, applicants and nonapplicants must submit each ICSR associated with the use of a designated medical gas in humans described in paragraph (b) of this section to FDA as soon as possible but no later than 15 calendar days from the date when the applicant or nonapplicant has met the reporting criteria described in paragraph (b) of this section and acquired a minimum data set for an ICSR for an adverse event.\n\n(2)  Copies of ICSRs obtained from FDA.  An applicant or nonapplicant should not resubmit under this section any ICSRs obtained from FDA's adverse event reporting database or forwarded to the applicant or nonapplicant by FDA.\n\n(3)  Followup information.  Applicants and nonapplicants must submit any new information that is related to a previously submitted ICSR or an ICSR that was sent to the applicant or nonapplicant by FDA no later than 15 calendar days after the information is received or otherwise obtained.\n\n(b)  Reporting requirements \u2014(1)  Serious adverse events \u2014(i)  Reported to or otherwise received by the applicant or nonapplicant.  Applicants and nonapplicants must submit ICSRs for serious adverse events reported to or otherwise received by the applicant or nonapplicant (such as a report initiated by a patient, consumer, or healthcare professional, or received at the request of the applicant or nonapplicant).\n\n(ii)  Reported from the scientific literature.  Applicants and nonapplicants must submit ICSRs for serious adverse events obtained from published scientific and medical journals either as case reports or as the result of a formal clinical trial.\n\n(iii)  Exception to reporting requirements for serious adverse events.  Notwithstanding paragraphs (b)(1)(i) and (ii) of this section, ICSRs are not required for reports of the death of a patient who was administered oxygen, unless the applicant or nonapplicant is aware of evidence to suggest that the death was caused by the administration of oxygen.\n\n(2)  Other adverse event reports to be submitted upon notification by FDA.  Upon notification by FDA, applicants and nonapplicants must submit, in a timeframe established by FDA, ICSRs for any adverse events that are not required under paragraph (b)(1) of this section. The notification will specify the adverse events to be reported and the reason for requiring the reports.\n\n(c)  Completing and submitting ICSRs.  This paragraph (c) describes how to complete and submit ICSRs required under this section.\n\n(1)  Electronic format for submissions.  (i) ICSRs and ICSR attachments must be in an electronic format that FDA can process, review, and archive.\n\n(ii) An applicant or nonapplicant may request, in writing, a temporary waiver of the requirements in paragraph (c)(1)(i) of this section. These waivers will be granted on a limited basis for good cause shown.\n\n(2)  Submitting ICSRs \u2014(i)  Single submission of each ICSR.  Submit each ICSR only once.\n\n(ii)  Separate ICSR for each patient.  The applicant or nonapplicant must submit a separate ICSR for each patient who experiences an adverse event reportable under paragraph (b) of this section.\n\n(iii)  Coding terms.  The adverse event terms described in the ICSR must be coded using standardized medical terminology.\n\n(iv)  Minimum data set.  All ICSRs submitted under this section must contain at least the minimum data set for an ICSR for an adverse event. The applicant or nonapplicant must actively seek the minimum data set in a manner consistent with the written procedures under paragraph (f) of this section. Applicants and nonapplicants must document and maintain records of their efforts to obtain the minimum data set.\n\n(v)  ICSR elements.  The applicant or nonapplicant must complete all known, available elements of an ICSR as specified in paragraph (d) of this section.\n\n(A) For adverse events, applicants and nonapplicants must actively seek any information needed to complete all applicable elements, consistent with their written procedures under paragraph (f) of this section.\n\n(B) Applicants and nonapplicants must document and maintain records of their efforts to obtain the missing information.\n\n(vi)  Supporting documentation.  An applicant or nonapplicant must submit the following types of supporting documentation in an ICSR, if available:\n\n(A) A copy of the autopsy report if the patient died, or a copy of the hospital discharge summary if the patient was hospitalized. The applicant or nonapplicant must submit each document as an ICSR attachment. The ICSR attachment must be submitted either with the initial ICSR or no later than 15 calendar days after obtaining the document. English translations of foreign language documents must be provided.\n\n(B) A copy of the published article as an ICSR attachment for each ICSR of an adverse event obtained from the published scientific and medical literature. Foreign language articles must be accompanied by an English translation of the abstract. When submitting more than one ICSR from the same published article, the applicant or nonapplicant must submit only one copy of the article with one of the ICSRs. For the remaining ICSRs not accompanied by a copy of the published article, the applicant or nonapplicant must include the cross-reference to the specific ICSR to which the article is attached.\n\n(d)  Information reported on ICSRs.  ICSRs must include the following information, subject to paragraph (c)(2)(v) of this section:\n\n(1) Patient information, which includes:\n\n(i) Patient identification code;\n\n(ii) Patient age at the time of adverse event, or date of birth;\n\n(iii) Patient sex; and\n\n(iv) Patient weight.\n\n(2) Adverse event, which includes:\n\n(i) Outcome attributed to adverse event;\n\n(ii) Date of adverse event;\n\n(iii) Date of ICSR submission;\n\n(iv) Description of adverse event;\n\n(v) Adverse event term(s);\n\n(vi) Description of relevant tests conducted, including dates and laboratory data; and\n\n(vii) Other relevant patient history, including preexisting medical conditions.\n\n(3) Suspect designated medical gas(es), which includes:\n\n(i) Name;\n\n(ii) Dose, frequency, and route of administration used;\n\n(iii) Therapy dates;\n\n(iv) Diagnosis for use (indication);\n\n(v) Whether the adverse event abated after the use of the designated medical gas(es) stopped or the dose was reduced;\n\n(vi) Whether the adverse event reappeared after reintroduction of the designated medical gas(es);\n\n(vii) Lot number;\n\n(viii) National Drug Code (NDC) number; and\n\n(ix) Concomitant medical products and therapy dates.\n\n(4) Initial reporter information, which includes:\n\n(i) Name, address, email address, and telephone number;\n\n(ii) Whether the initial reporter is a healthcare professional; and\n\n(iii) Occupation, if a healthcare professional.\n\n(5) Applicant or nonapplicant information, which includes:\n\n(i) Applicant or nonapplicant name, address, email address, and telephone number;\n\n(ii) Report source, such as spontaneous, literature, or study;\n\n(iii) Date the report was received by applicant or nonapplicant;\n\n(iv) New drug application and/or new animal drug application number;\n\n(v) Whether the ICSR is an expedited report;\n\n(vi) Whether the ICSR is an initial report or followup report; and\n\n(vii) Unique case identification number, which must be the same in the initial report and any subsequent followup report(s).\n\n(e)  Recordkeeping.  (1) For a period of 10 years from the initial receipt of information, each applicant or nonapplicant must maintain records of information relating to adverse events under this section, whether or not submitted to FDA.\n\n(2) These records must include raw data, correspondence, and any other information relating to the evaluation and reporting of adverse event information that is received or otherwise obtained by the applicant or nonapplicant.\n\n(3) Upon written notice by FDA, the applicant or nonapplicant must submit any or all of these records to FDA within 5 calendar days after receipt of the notice. The applicant or nonapplicant must permit any authorized FDA employee, at reasonable times, to access, copy, and verify these established and maintained records described in this section.\n\n(f)  Written procedures.  The applicant or nonapplicant must develop written procedures needed to fulfill the requirements in this section for the surveillance, receipt, evaluation, and reporting to FDA of adverse event information, including procedures for employee training and for obtaining and processing adverse event information from other applicants and nonapplicants.\n\n(g)  Patient privacy.  An applicant or nonapplicant should not include in reports under this section the names and addresses of individual patients; instead, the applicant or nonapplicant should assign a unique code for identification of the patient. The applicant or nonapplicant should include the name of the reporter from whom the information was received as part of the initial reporter information, even when the reporter is the patient. As set forth in FDA's public information regulations in part 20 of this chapter, FDA generally may not disclose the names of patients, individual reporters, healthcare professionals, hospitals, and geographical identifiers submitted to FDA in adverse event reports."], ["21:21:4.0.1.1.17.3.1.4", 21, "Food and Drugs", "I", "C", "230", "PART 230\u2014CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES", "C", "Subpart C\u2014Postmarketing Quality and Safety Reporting", "", "\u00a7 230.230 Animal designated medical gas adverse event reporting requirements.", "FDA", "", "", "", "(a)  Report for adverse events.  This report provides information on each adverse event associated with the use of a designated medical gas in animals, regardless of the source of the information.\n\n(1)  Serious adverse events.  The applicant or nonapplicant must submit serious adverse events to FDA as soon as possible but no later than within 15 calendar days of first receiving the information. The report must be submitted to the Agency in electronic format as described in paragraph (b)(1) of this section, unless the applicant or nonapplicant obtains a waiver under paragraph (b)(2) of this section or FDA requests the report in an alternate format.\n\n(i)  Reported to or otherwise received by the applicant or nonapplicant.  Applicants and nonapplicants must submit reports for  each serious adverse event  reported to or otherwise received by the applicant or nonapplicant (such as reports initiated by a patient, consumer, veterinarian, or other healthcare professional, or received at the request of the applicant or nonapplicant), regardless of whether the applicant or nonapplicant believes the events are related to the designated medical gas.\n\n(ii)  Reported from the scientific and medical literature.  Applicants and nonapplicants must submit reports for each serious adverse event obtained from the published scientific and medical literature regardless of whether the applicant or nonapplicant believes the events are related to the designated medical gas.\n\n(iii)  Exception to reporting requirements for serious adverse events.  Notwithstanding paragraphs (a)(1)(i) and (ii) of this section, reports are not required to be submitted for the death of an animal that was administered oxygen, unless the applicant or nonapplicant becomes aware of evidence to suggest that the death was caused by the administration of oxygen.\n\n(2)  Other adverse event reports to be submitted upon notification by FDA.  Upon notification by FDA, applicants and nonapplicants must submit reports of adverse events associated with the use of a designated medical gas in animals that do not qualify for reporting under paragraph (a)(1) of this section. The notice will specify the adverse events to be reported and the reason for requiring the reports.\n\n(3)  Copies of adverse event reports obtained from FDA.  An applicant or nonapplicant should not resubmit under this section any adverse event reports obtained from FDA's adverse event reporting database or forwarded to the applicant or nonapplicant by FDA.\n\n(b)  Format for submissions \u2014(1)  Electronic submissions.  Reports submitted to FDA under this section must be submitted in an electronic format that FDA can process, review, and archive. Data provided in electronic submissions must be in conformance with the data elements in Form FDA 1932 and FDA technical documents describing transmission. As necessary, FDA will issue updated technical documents on how to provide the electronic submission ( e.g.,  method of transmission and processing, media, file formats, preparation and organization of files). Unless requested by FDA, paper copies of reports submitted electronically should not be submitted to FDA.\n\n(2)  Waivers.  An applicant or nonapplicant may request, in writing, a temporary waiver of the electronic submission requirements in paragraph (b)(1) of this section. The initial request may be provided by telephone or email to the Center for Veterinary Medicine's Division of Pharmacovigilance and Surveillance, with prompt written followup submitted as a letter to the granted certification(s). FDA will grant waivers on a limited basis for good cause shown. If FDA grants a waiver, the applicant or nonapplicant must comply with the conditions for reporting specified by FDA upon granting the waiver.\n\n(c)  Records to be maintained.  (1) For a period of 5 years from the initial receipt of information, each applicant or nonapplicant must maintain records of information relating to adverse event reports under this section, whether or not submitted to FDA.\n\n(2) These records must include raw data, correspondence, and any other information relating to the evaluation and reporting of adverse event information that is received or otherwise obtained by the applicant or nonapplicant.\n\n(3) Upon written notice by FDA, the applicant or nonapplicant must submit any or all of these records to FDA within 5 calendar days after receipt of the notice. The applicant or nonapplicant must permit any authorized FDA employee, at reasonable times, to access, copy, and verify these established and maintained records described in this section."]], "truncated": false, "filtered_table_rows_count": 15, "expanded_columns": [], "expandable_columns": [], "columns": ["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"], "primary_keys": ["section_id"], "units": {}, "query": {"sql": "select 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 from cfr_sections where \"agency\" = :p0 and \"part_number\" = :p1 order by section_id limit 101", "params": {"p0": "FDA", "p1": "230"}}, "facet_results": {"title_number": {"name": "title_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?agency=FDA&part_number=230", "results": [{"value": 21, "label": 21, "count": 15, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?agency=FDA&part_number=230&title_number=21", "selected": false}], "truncated": false}, "agency": {"name": "agency", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?agency=FDA&part_number=230", "results": [{"value": "FDA", "label": "FDA", "count": 15, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=230", "selected": true}], "truncated": false}, "part_number": {"name": "part_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?agency=FDA&part_number=230", "results": [{"value": "230", "label": "230", "count": 15, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?agency=FDA", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "subpart", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?agency=FDA&part_number=230&_facet=subpart"}, {"name": "subpart_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?agency=FDA&part_number=230&_facet=subpart_name"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 810.538181103766, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}