[Federal Register Volume 73, Number 242 (Tuesday, December 16, 2008)]
[Notices]
[Pages 76364-76366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29742]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0610]


Draft Guidance for Industry on Postmarketing Adverse Event 
Reporting for Medical Products and Dietary Supplements During an 
Influenza Pandemic; 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availability of a draft guidance for industry entitled ``Postmarketing 
Adverse Event Reporting for Medical Products and Dietary Supplements 
During an Influenza Pandemic.'' The draft guidance discusses FDA's 
intended approach to enforcement of adverse event reporting 
requirements for drugs, biologics, medical devices, and dietary 
supplements during the Federal Government Response Stages of an 
influenza pandemic. The agency makes recommendations to industry for 
focusing limited resources on reports related to influenza-related 
products and other specific types of reports indicated in the draft 
guidance.

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 comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by February 17, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire

[[Page 76365]]

Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or the Office 
of Communication, Training and Manufacturers Assistance (HFM-40), 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The 
draft guidance may also be obtained by mail by calling CBER at 1-800-
835-4709 or 301-827-1800. Send one self-addressed adhesive label to 
assist that office in processing your requests. 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on the draft guidance to the Division of Dockets Management (HFA-305), 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:
    Regarding pandemic influenza: Carmen Maher, Office of 
Counterterrorism and Emerging Threats (HF-29), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.
    Regarding human drug products: Solomon Iyasu, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4447, Silver Spring, MD 20993-0002, 301-
796-2370.
    Regarding human biological products: Stephen Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
    Regarding medical device products: Deborah Moore, Center for 
Devices and Radiological Health (HFZ-533), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3442.
    Regarding dietary supplements: John Sheehan, Center for Food Safety 
and Applied Nutrition (HFS-315), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1488.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Postmarketing Adverse Event Reporting for Medical Products 
and Dietary Supplements During an Influenza Pandemic.'' FDA anticipates 
that during an influenza pandemic, industry and FDA workforces may be 
reduced while reporting of adverse events related to widespread use of 
influenza-related products may increase, although the extent of these 
possible changes is unknown. This draft guidance discusses FDA's 
intended approach to enforcement of adverse event reporting 
requirements for drugs, biologics, medical devices, and dietary 
supplements in the event of an influenza pandemic. The draft guidance 
provides recommendations to permit industry to focus their limited 
resources on reports related to influenza-related products and other 
specific types of reports. The draft guidance indicates FDA's intention 
not to object if, during Federal Government Response Stage 5, certain 
required adverse event reports are not provided within the timeframes 
required by statute and regulation, as long as any delayed reports are 
then provided during Federal Government Response Stage 6.
    This draft guidance does not address monitoring and reporting of 
adverse events that might be imposed as a condition of authorization 
for products authorized for emergency use under section 564 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb-3). 
This draft guidance also does not address monitoring and reporting of 
adverse events as required by regulations establishing the conditions 
for investigational use of drugs, biologics, and devices. (See 21 CFR 
parts 312 and 812.)
    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 
postmarketing adverse event reporting for medical products and dietary 
supplements during pandemic influenza. 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.

III. Paperwork Reduction Act of 1995

    The draft guidance explains FDA's approach to enforcement of 
adverse event reporting requirements for drugs, biologics, medical 
devices, and dietary supplements during the Federal Government Response 
Stages of an influenza pandemic, including an intent not to object to 
changes in the timing of submission of certain reports during some 
stages of the pandemic response. The draft guidance refers to reporting 
requirements found in 21 CFR 310.305, 314.80, 314.98, 600.80, 606.170, 
640.73, 1271.350, and part 803. These regulations contain collections 
of information that are subject to review by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520) and are approved under OMB control numbers 0910-0116, 0910-
0291, 0910-0230, 0910-0308, and 0910-0543.
    The draft guidance also refers to adverse event reports required 
under sections 760 and 761 of the act (21 U.S.C. 379aa and 379aa-1), 
which are addressed in two draft guidances for industry. FDA's October 
15, 2007, notices of availability for those draft guidances, entitled 
``Postmarketing Adverse Event Reporting for Nonprescription Human Drug 
Products Marketed Without an Approved Application'' (72 FR 58316) and 
``Questions and Answers Regarding Adverse Event Reporting and 
Recordkeeping for Dietary Supplements as Required by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act'' (72 FR 
58313), describe related proposed collections of information. As 
required by the PRA, FDA published analyses of the information 
collection provisions of the October 2007 draft guidances and will 
submit the collection of information analyses to OMB for approval prior 
to issuing final guidances.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/cdrh/guidance.html or http://www.cfsan.fda.gov/~dms/

[[Page 76366]]

guidance.html or http://www.regulations.gov.

    Dated: December 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29742 Filed 12-15-08; 8:45 am]
BILLING CODE 4160-01-S