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[Federal Register: December 16, 2008 (Volume 73, Number 242)]
[Notices]
[Page 76364-76366]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de08-62]
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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Draft Guidance for Industry on Postmarketing Adverse Event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.
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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availability of a draft guidance for industry entitled ``Postmarketing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 The draft guidance discusses FDA's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products and other specific types of reports indicated in the draft
guidance.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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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draft guidance may also be obtained by mail by calling CBER at 1-800-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on the draft guidance to the Division of Dockets Management (HFA-305),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