(a) * * *
Individual case safety report (ICSR). A description of an adverse experience related to an individual patient or subject.
ICSR attachments. Documents related to the adverse experience described in an ICSR, such as medical records, hospital discharge summaries, or other documentation.
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(c) Reporting requirements. The applicant must submit to FDA postmarketing 15-day Alert reports and periodic safety reports pertaining to its biological product as described in this section. These reports must be submitted to the Agency in electronic format as described in paragraph (h)(1) of this section, except as provided in paragraph (h)(2) of this section.
(1) * * *
(iii) Submission of reports. The requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of postmarketing 15-day Alert reports, also apply to any person whose name appears on the label of a licensed biological product as a manufacturer, packer, distributor, shared manufacturer, joint manufacturer, or any other participant involved in divided manufacturing. * * * If a person elects to submit adverse experience reports to the applicant rather than to FDA, the person must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the person, and the applicant must then comply with the requirements of this section. * * *
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(2) * * *
(ii) Each periodic report is required to contain:
(A) Descriptive information. (1) A narrative summary and analysis of the information in the report;
(2) An analysis of the 15-day Alert reports submitted during the reporting interval (all 15-day Alert reports being appropriately referenced by the applicant's patient identification code for nonvaccine biological product reports or by the unique case identification number for vaccine reports, adverse reaction term(s), and date of submission to FDA);
(3) A history of actions taken since the last report because of adverse experiences (for example, labeling changes or studies initiated);
(4) An index consisting of a line listing of the applicant's patient identification code for nonvaccine biological product reports or by the unique case identification number for vaccine reports and adverse reaction term(s) for ICSRs submitted under paragraph (c)(2)(ii)(B) of this section; and
(B) ICSRs for serious, expected and, nonserious adverse experiences. An ICSR for each adverse experience not reported under paragraph (c)(1)(i) of this section (all serious, expected and nonserious adverse experiences). All such ICSRs must be submitted to FDA (either individually or in one or more batches) within the timeframe specified in paragraph (c)(2)(i) of this section. ICSRs must only be submitted to FDA once.
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(d) Scientific literature. A 15-day Alert report based on information in the scientific literature must be accompanied by a copy of the published article. * * *
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(f) Information reported on ICSRs for nonvaccine biological products. ICSRs for nonvaccine biological products include the following information:
(1) Patient information.
(i) Patient identification code;
(ii) Patient age at the time of adverse experience, or date of birth;
(iii) Patient gender; and
(iv) Patient weight.
(2) Adverse experience.
(i) Outcome attributed to adverse experience;
(ii) Date of adverse experience;
(iii) Date of report;
(iv) Description of adverse experience (including a concise medical narrative);
(v) Adverse experience term(s);
(vi) Description of relevant tests, including dates and laboratory data; and
(vii) Other relevant patient history, including preexisting medical conditions.
(3) Suspect medical product(s).
(i) Name;
(ii) Dose, frequency, and route of administration used;
(iii) Therapy dates;
(iv) Diagnosis for use (indication);
(v) Whether the product is a combination product as defined in Sec. 3.2(e) of this chapter;
(vi) Whether the product is a prescription or nonprescription product;
(vii) Whether adverse experience abated after product use stopped or dose reduced;
(viii) Whether adverse experience reappeared after reintroduction of the product;
(ix) Lot number;
(x) Expiration date;
(xi) National Drug Code (NDC) number, or other unique identifier; and
(xii) Concomitant medical products and therapy dates.
(4) Initial reporter information.
(i) Name, address, and telephone number;
(ii) Whether the initial reporter is a health care professional; and
(iii) Occupation, if a health care professional.
(5) Applicant information.
(i) Applicant name and contact office address;
(ii) Telephone number;
(iii) Report source, such as spontaneous, literature, or study;
(iv) Date the report was received by applicant;
(v) Application number and type;
(vi) Whether the ICSR is a 15-day ``Alert report'';
(vii) Whether the ICSR is an initial report or followup report; and
(viii) Unique case identification number, which must be the same in the initial report and any subsequent followup report(s).
(g) Information reported on ICSRs for vaccine products. ICSRs for vaccine products include the following information:
(1) Patient information.
(i) Patient name, address, telephone number;
(ii) Patient age at the time of vaccination, or date of birth;
(iii) Patient gender; and
(iv) Patient birth weight for children under age 5.
(2) Adverse experience.
(i) Outcome attributed to adverse experience;
(ii) Date and time of adverse experience;
(iii) Date of report;
(iv) Description of adverse experience (including a concise medical narrative);
(v) Adverse experience term(s);
(vi) Illness at the time of vaccination;
(vii) Description of relevant tests, including dates and laboratory data; and
(viii) Other relevant patient history, including preexisting medical conditions.
(3) Suspect medical product(s), including vaccines administered on the same date.
(i) Name;
(ii) Dose, frequency, and route or site of administration used;
(iii) Number of previous vaccine doses;
(iv) Vaccination date(s) and time(s);
(v) Diagnosis for use (indication);
(vi) Whether the product is a combination product (as defined in Sec. 3.2(e) of this chapter);
(vii) Whether the adverse experience abated after product use stopped or dose reduced;
(viii) Whether the adverse experience reappeared after reintroduction of the product;
(ix) Lot number;
(x) Expiration date;
(xi) National Drug Code (NDC) number, or other unique identifier; and
(xii) Concomitant medical products and therapy dates.
(4) Vaccine(s) administered in the 4 weeks prior to the vaccination date.
(i) Name of vaccine;
(ii) Manufacturer;
(iii) Lot number;
(iv) Route or site of administration;
(v) Date given; and
(vi) Number of previous doses.
(5) Initial reporter information.
(i) Name, address, and telephone number;
(ii) Whether the initial reporter is a health care professional; and
(iii) Occupation, if a health care professional.
(6) Facility and personnel where vaccine was administered.
(i) Name of person who administered vaccine;
(ii) Name of responsible physician at facility where vaccine was administered; and
(iii) Name, address (including city, county, and state), and telephone number of facility where vaccine was administered.
(7) Applicant information.
(i) Applicant name and contact office address;
(ii) Telephone number;
(iii) Report source, such as spontaneous, literature, or study;
(iv) Date received by applicant;
(v) Application number and type;
(vi) Whether the ICSR is a 15-day ``Alert report'';
(vii) Whether the ICSR is an initial report or followup report; and
(viii) Unique case identification number, which must be the same in the initial report and any subsequent followup report(s).
(h) Electronic format for submissions. (1) Safety report submissions, including ICSRs, ICSR attachments, and the descriptive information in periodic reports, must be in an electronic format that FDA can process, review, and archive. FDA will issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files).
(1) Safety report submissions, including ICSRs, ICSR attachments, and the descriptive information in periodic reports, must be in an electronic format that FDA can process, review, and archive. FDA will issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files).
(2) Persons subject to the requirements of paragraph (c) of this section may request, in writing, a temporary waiver of the requirements in paragraph (h)(1) of this section. These waivers will be granted on a limited basis for good cause shown. FDA will issue guidance on requesting a waiver of the requirements in paragraph (h)(1) of this section. Requests for waivers must be submitted in accordance with Sec. 600.90.
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(j) Patient privacy. For nonvaccine biological products, an applicant should not include in reports under this section the names and addresses of individual patients; instead, the applicant should assign a unique code for identification of the patient. The applicant 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. The names of patients, health care professionals, hospitals, and geographical identifiers in adverse experience reports are not releasable to the public under FDA's public information regulations in part 20 of this chapter. For vaccine adverse experience reports, these data will become part of the CDC Privacy Act System 09-20-0136, ``Epidemiologic Studies and Surveillance of Disease Problems.'' Information identifying the person who received the vaccine or that person's legal representative will not be made available to the public, but may be available to the vaccinee or legal representative.
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