[Federal Register Volume 75, Number 188 (Wednesday, September 29, 2010)]
[Notices]
[Pages 60129-60130]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry and Investigators on Safety Reporting 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availability of a draft guidance for industry and investigators 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This draft guidance is intended to help sponsors and investigators 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 28, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.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 Submit electronic comments on the draft guidance 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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