[Federal Register Volume 73, Number 114 (Thursday, June 12, 2008)]
[Notices]
[Pages 33436-33438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13269]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0067] (formerly Docket No. 2001D-0185)


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Postmarketing Individual Case Safety Reports; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Postmarketing Individual 
Case Safety Reports.'' This draft guidance consolidates and revises 
information in two existing draft guidances pertaining to electronic 
submission of postmarketing individual case safety reports (ICSRs) and 
attachments to ICSRs (ICSR attachments). The submission of ICSRs and 
ICSR attachments in an electronic format significantly improves the 
agency's efficiency in processing, archiving, and reviewing the 
reports.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance, 
including comments regarding proposed collection of information, by 
August 11, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or to 
the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist that 
office in processing your

[[Page 33437]]

requests. The guidance may also be obtained by calling CBER at 1-800-
835-4709 or 301-827-1800. Submit written comments on the draft guidance 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT:
    Roger Goetsch, Center for Drug Evaluation and Research (HFD-410), 
Food and Drug Administration, 12300 Twinbrook Pkwy., suite 240, 
Rockville, MD 20851, 301-770-9299; or
    Steven Ripley, Center for Biologics Evaluation and Research (HFM-
17),Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852,301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Postmarketing Individual Case Safety Reports'' (the electronic ICSR 
draft guidance). The electronic ICSR draft guidance will apply to drug 
products marketed for human use with approved new drug applications 
(NDAs) and abbreviated new drug applications (ANDAs); prescription drug 
products marketed for human use without an approved NDA or ANDA; 
nonprescription drug products marketed without an approved application; 
biological products, including therapeutic vaccines, marketed for human 
use with approved biologic license applications (BLAs) and submission 
tracking numbers (STNs); and human cells, tissues, and cellular and 
tissue-based products (HCT/Ps) regulated under section 361 of the 
Public Health Service Act (the PHS Act) (42 U.S.C. 264). The electronic 
ICSR draft guidance will not apply to prophylactic vaccines, whole 
blood, or components of whole blood.

A. Consolidation of Earlier Guidance

    This electronic ICSR draft guidance consolidates and revises 
information pertaining to electronic submission of postmarketing ICSRs 
and ICSR attachments in the following guidances:
     Draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Postmarketing Expedited 
Safety Reports'' issued in May 2001 (Expedited Reports draft guidance) 
(66 FR 22585, May 4, 2001), and
     Draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Postmarketing Periodic 
Adverse Drug Experience Reports'' issued in June 2003 (Periodic Reports 
draft guidance) (68 FR 37504, June 24, 2003).
    The electronic ICSR draft guidance replaces the Expedited Reports 
draft guidance in its entirety, and we have removed the Expedited 
Reports draft guidance from the Center for Drug Evaluation and Research 
(CDER) and CBER's guidance pages. The electronic ICSR draft guidance 
also replaces the ICSR and ICSR attachment portion of the Periodic 
Reports draft guidance, but does not address the descriptive 
information portion. We have removed the Periodic Reports draft 
guidance from CDER and CBER's guidance pages. For information on 
electronic submission of the descriptive information portion of 
periodic adverse drug experience reports, see the section on periodic 
safety update reports in the guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Human Pharmaceutical 
Product Applications and Related Submissions Using the eCTD 
Specifications'' (see Revision 2, June 2008).

B. International Standards for Electronic Transmission

    FDA has cooperated with industry associations, standards 
development organizations, and the regulatory authorities of certain 
other nations to promote international harmonization of regulatory 
requirements. Much of this effort has been coordinated through the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). Under the auspices 
of the ICH, standards for electronic submission of safety information 
for human drug and biological products have been developed. This draft 
guidance is intended to provide guidance to industry regarding 
submission of postmarketing ICSRs and ICSR attachments to FDA in 
electronic form using the standards established by the ICH.

C. Updated Recommendations

    As a result of comments received on the Expedited Reports and 
Periodic Reports draft guidances, as well as evolving technology, a 
number of substantive changes have been made to the agency's 
recommendations for the electronic transmission of ICSRs and ICSR 
attachments. In addition to consolidating all the information 
pertaining to electronic submission of ICSRs and ICSR attachments into 
a single guidance, the electronic ICSR draft guidance also provides 
references to technical specifications for these submissions.
    Since the Expedited Reports and Periodic Reports draft guidances 
were issued, the agency has received ICSRs for HCT/Ps regulated under 
section 361 of the PHS Act. On December 22, 2006, the President signed 
the Dietary Supplement and Nonprescription Drug Consumer Protection Act 
(Public Law 109-462), which amended the Federal Food, Drug, and 
Cosmetic Act to add safety reporting requirements for nonprescription 
drug products marketed without an approved application (21 U.S.C. 
379aa). The recommendations in this electronic ICSR draft guidance will 
apply to these products as well as to products with approved NDAs, 
ANDAs, BLAs and STNs, and prescription drug products marketed without 
an approved NDA or ANDA.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on providing 
postmarketing ICSRs and ICSR attachments in electronic format. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations/gov.

[[Page 33438]]

III. Paperwork Reduction Act of 1995

    This electronic ICSR draft guidance refers to proposed collections 
of information required by Public Law 109-462 and subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (the PRA) (44 U.S.C. 3501-3520). As required by the PRA, 
FDA is now requesting public comment (see DATES) on these proposed 
collections of information. The agency's analysis and estimates of the 
proposed collections of information in the electronic ICSR draft 
guidance that are required by Public Law 109-462 have been described 
previously in FDA's notice of availability for a draft guidance 
entitled ``Postmarketing Adverse Event Reporting for Nonprescription 
Human Drug Products Marketed Without an Approved Application'' (72 FR 
58316, October 15, 2007) (the October 2007 PRA analysis). For burden 
estimates for the proposed collections of information in the electronic 
ICSR draft guidance, see the October 2007 PRA analysis.
    This electronic ICSR draft guidance also refers to previously 
approved collections of information found in FDA regulations. The 
collections of information in 21 CFR 310.305, 314.80, 600.80, and 
1271.350 have been approved under OMB control numbers 0910-0291, 0910-
0230, 0910-0308, and 0910-0543 respectively.

IV. Electronic Access

    Persons with access to the Internet may obtain the document 
athttp://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/
guidelines.htm, or http://www.regulations.gov.

    Dated: June 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13269 Filed 6-11-08; 8:45 am]
BILLING CODE 4160-01-S