(vii) Unique case identification number, which must be the same in
the initial report and any subsequent followup report(s).
    (c) Electronic format for submissions. (1) Each report required to
be submitted to FDA under section 760 of the FD&C Act, accompanied by a
copy of the label on or within the retail package of the drug and any
other documentation (as ICSR attachments), 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) The responsible person may request, in writing, a temporary
waiver of the requirements in paragraph (c)(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 (c)(1) of this section.
    (d) Patient privacy. The responsible person should not include in
reports under this section the names and addresses of individual
patients; instead, the responsible person should assign a unique code
for identification of the patient. The responsible person 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 drug event reports are not releasable to the
public under FDA's public information regulations in part 20 of this
chapter.

PART 600--BIOLOGICAL PRODUCTS: GENERAL

0
7. The authority citation for 21 CFR part 600 is revised to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371,
374, 379k-1; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.

Sec.  600.2  [Amended]

0
8. Section 600.2 is amended:
0
a. In paragraph (a) by removing the phrase ``paragraphs (c) or (d)''
and adding in its place ``paragraph (c)'', and by removing the phrase
``adverse experience reports'';
0
b. In paragraph (b) introductory text by removing the phrase
``paragraphs (b)(1), (b)(2), (b)(3), or (c)'' and adding in its place
``paragraphs (b)(1), (b)(2), or (c) ``
0
c. By removing paragraph (b)(2) and redesignating paragraph (b)(3) as
paragraph (b)(2);
0
d. By removing paragraph (d) and redesignating paragraphs (e) and (f)
as paragraphs (d) and (e).
0
e. In newly redesignated paragraph (e) by removing the Web address
``http://www.fda.gov/cber/pubinquire.htm'' and adding in its place
``http://www.fda.gov/BiologicsBloodVaccines/default.htm'' and by
removing the Web address ``http://www.fda.gov/cder/biologics/default.htm'' and adding in its place ``http://www.fda.gov/Drugs/default.htm''.

0
9. Section 600.80 is amended:
0
a. By removing the word ``shall'' each time it appears and by adding in
its place the word ``must'';
0
b. By removing the phrase ``licensed manufacturer'' or ``licensed
manufacturers'' each time it appears and by adding in its place the
word ``applicant'' or ``applicants'' respectively;
0
c. By removing the phrase ``Licensed manufacturer'' or ``Licensed
manufacturers'' each time it appears and by adding in its place the
word ``Applicant'' or ``Applicants'' respectively;
0
d. In paragraph (a) by alphabetically adding the definitions for
``Individual case safety report (ICSR)'' and ``ICSR attachments'';
0
e. In paragraph (c)(1)(i) by removing the phrase ``in no case later
than 15 calendar days of'' and by adding in its place the phrase ``no
later than 15 calendar days from'';
0
f. In paragraph (c)(1)(ii) by removing the last sentence;
0
g. By removing paragraph (c)(1)(iv);
0
h. By revising paragraph (c) introductory text, the first and third
sentences of paragraph (c)(1)(iii) introductory text, and paragraph
(c)(2)(ii);
0
i. By removing paragraph (d)(2) and by redesignating paragraph (d)(1)
as paragraph (d) and revising the first sentence of paragraph (d);
0
j. By removing paragraph (e)(2) and by redesignating paragraph (e)(1)
as paragraph (e);
0
k. By revising paragraph (f);
0
l. By redesignating paragraph (g) through paragraph (l) as paragraph
(i) through paragraph (n) and by revising newly redesignated paragraph
(j); and
0
m. By adding new paragraphs (g) and (h) to read as follows:

Sec.  600.80  Postmarketing reporting of adverse experiences.

    (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.
* * * * *
    (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. * * *
* * * * *
    (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.
* * * * *
    (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. * * *
* * * * *
    (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).
    (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.
* * * * *
    (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.
* * * * *

0
10. Section Sec.  600.81 is amended:
0
a. By removing the phrase ``licensed manufacturer'' each time it
appears and by adding in its place the word ``applicant'';
0
b. By removing the word ``shall'' each time it appears and by adding in
its place the word ``must'';
0
c. By designating the existing text as paragraph (a) and by adding a
heading for newly designated paragraph (a);

0
d. In newly designated paragraph (a), by removing from the first
sentence the phrase ``(see mailing addresses in Sec.  600.2)''; and
0
e. By adding new paragraph (b) to read as follows:

Sec.  600.81  Distribution reports.

    (a) Reporting requirements. * * *
    (b)(1) Electronic format. Except as provided for in paragraph
(b)(2) of this section, the distribution reports required under
paragraph (a) of this section must be submitted to the Agency 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) Waivers. An applicant may request, in writing, a temporary
waiver of the requirements in paragraph (b)(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 (b)(1) of this section. Requests for waivers must be
submitted in accordance with Sec.  600.90.

Sec.  600.90  [Amended]

0
11. Section 600.90 is amended by removing the phrase ``licensed
manufacturer'' or ``licensed manufacturer's'' each time it appears and
by adding in its place the word ``applicant'' or ``applicant's''
respectively.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13480 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P