[Federal Register Volume 75, Number 188 (Wednesday, September 29, 2010)]
[Notices]
[Pages 60129-60130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24295]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0482]
Draft Guidance for Industry and Investigators on Safety Reporting
Requirements for Investigational New Drug Applications and
Bioavailability/Bioequivalence Studies; 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availability of a draft guidance for industry and investigators
entitled ``Safety Reporting Requirements for INDs and BA/BE Studies.''
This draft guidance is intended to help sponsors and investigators
comply with the new requirements in the final rule entitled
``Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety
[[Page 60130]]
Reporting Requirements for Bioavailability and Bioequivalence Studies
in Humans,'' published elsewhere in this issue of the Federal Register.
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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 28, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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
the Office of Communication, Outreach, and Development (HFM-40), Center
for Biologics Evaluation and Research, 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
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments on the draft guidance
to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Janet Norden, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6324, Silver Spring, MD 20993-0002, 301-
796-2500; or Laura Rich, Center for Biologics Evaluation and Research,
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and investigators entitled ``Safety Reporting Requirements for INDs and
BA/BE Studies.'' This draft guidance is intended to help sponsors and
investigators comply with the new requirements for investigational new
drug applications (IND) safety reporting and safety reporting for
bioavailability (BA) and bioequivalence (BE) studies.
In the Federal Register of March 14, 2003 (68 FR 12406), FDA
published a proposed rule to revise its regulations governing pre- and
postmarket safety reporting for human drug and biological products. To
make rulemaking more manageable, the Agency decided to issue revisions
to the pre- and postmarket safety reporting regulations in two separate
rulemakings. The final rule, entitled ``Investigational New Drug Safety
Reporting Requirements for Human Drug and Biological Products and
Safety Reporting Requirements for Bioavailability and Bioequivalence
Studies in Humans,'' published elsewhere in this issue of the Federal
Register, revises the premarket regulations. The revisions in the final
rule will improve the utility and quality of safety reports, expedite
and strengthen FDA's ability to review critical safety information,
improve safety monitoring of human drug and biological products, better
protect human subjects enrolled in clinical trials, and harmonize
safety reporting internationally. The new requirements revise the
definitions used for IND safety reporting, make clear when to submit
IND safety reports, and subject BA and BE studies to safety reporting
requirements.
The draft guidance was developed to accompany the publication of
the final rule. The draft guidance provides examples and explanations
of the definitions used for IND safety reporting, makes recommendations
for determining when and how to submit a safety report, and provides
advice on other safety reporting issues that have generated questions
from sponsors and investigators.
The 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 safety
reporting requirements for INDs and BA/BE studies. 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) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
III. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions 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). The
collection(s) of information in the draft guidance are estimated in
section ``VII. Paperwork Reduction Act of 1995'' of the final rule
entitled, ``Investigational New Drug Safety Reporting Requirements for
Human Drug and Biological Products and Safety Reporting Requirements
for Bioavailability and Bioequivalence Studies in Humans'' published
elsewhere in this issue of the Federal Register.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: September 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24295 Filed 9-28-10; 8:45 am]
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