[Federal Register Volume 76, Number 109 (Tuesday, June 7, 2011)]
[Rules and Regulations]
[Pages 32863-32864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 312 and 320

[Docket No. FDA-2010-D-0482]


Guidance for Industry and Investigators on Enforcement of Safety 
Reporting Requirements for Investigational New Drug Applications and 
Bioavailability/Bioequivalence Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of guidance.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry and investigators entitled 
``Enforcement of Safety Reporting Requirements for INDs and BA/BE 
Studies.'' This guidance is intended to inform sponsors and 
investigators of FDA's intent to exercise enforcement discretion 
regarding the reporting requirements in the final rule, 
``Investigational New Drug Safety Reporting Requirements for Human Drug 
and Biological Products and Safety Reporting Requirements for 
Bioavailability and Bioequivalence Studies in Humans'' (75 FR 59935, 
September 29, 2010), until September 28, 2011. This action is being 
taken in response to requests from sponsors to extend the March 28, 
2011, effective date of the final rule. FDA expects all sponsors and 
investigators to be in compliance with the new regulations no later 
than September 28, 2011.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-

[[Page 32864]]

305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Stephanie Shapley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6323, Silver Spring, MD 20993-0002, 301-
796-4836; or Laura Rich, Center for Biologics Evaluation and Research 
(HFM-17), 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 guidance for industry and 
investigators entitled ``Enforcement of Safety Reporting Requirements 
for INDs and BA/BE Studies.'' This guidance is being issued consistent 
with FDA's good guidance practices (GGPs) regulation (Sec.  10.115 (21 
CFR 10.115)). The guidance provides that the Agency intends to grant a 
6-month period of enforcement discretion relating to the new reporting 
requirements (described in this document) that became effective on 
March 28, 2011. Accordingly, this guidance is being implemented without 
prior public comment because the Agency has determined that prior 
public participation is not feasible or appropriate (Sec.  
10.115(g)(2)). The Agency made this determination because the guidance 
deals with a short-term and highly time-sensitive issue. Although this 
guidance document is immediately in effect, it remains subject to 
comment in accordance with the Agency's GGPs regulation.
    On September 29, 2010, FDA published a final rule ``Investigational 
New Drug Safety Reporting Requirements for Human Drug and Biological 
Products and Safety Reporting Requirements for Bioavailability and 
Bioequivalence Studies in Humans'' (75 FR 59935) and issued related 
draft guidance ``Safety Reporting Requirements for INDs and BA/BE 
Studies'' (75 FR 60129, Docket No. FDA-2010-D-0482). The final rule 
amended the investigational new drug safety reporting requirements 
under part 312 (21 CFR part 312) and added safety reporting 
requirements for persons conducting bioavailability and bioequivalence 
studies under part 320 (21 CFR part 320). The effective date for the 
final rule was March 28, 2011. In comments to the docket, and in other 
communications to the Agency placed in the docket, stakeholders have 
requested an extension to the effective date of the final rule because 
of the need for significant internal process changes in order to meet 
the new requirements. Specifically, the comments indicated that 
sponsors needed additional time to implement changes to their internal 
procedures to comply with the new reporting requirements. The Agency 
acknowledges these concerns and intends to exercise enforcement 
discretion regarding the reporting requirements in the final rule until 
September 28, 2011. During this period of time, FDA does not intend to 
take enforcement action if sponsors and investigators report in 
compliance with the reporting requirements under Sec. Sec.  312.32, 
312.64, and 320.31 that were in effect prior to March 28, 2011.
    The guidance represents the Agency's current thinking on 
enforcement of safety reporting requirements for investigational new 
drug applications and bioavailability/bioequivalence 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. Electronic Access

    Persons with access to the Internet may obtain the document at 
either  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov. Always access an FDA guidance document by using 
FDA's Web site listed previously to find the most current version of 
the guidance.

    Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13950 Filed 6-6-11; 8:45 am]
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