
[Federal Register Volume 77, Number 245 (Thursday, December 20, 2012)]
[Notices]
[Pages 75439-75440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30651]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidances for Industry and Investigators on Safety Reporting 
Requirements for Investigational New Drug Applications and 
Bioavailability/Bioequivalence Studies, and a Small Entity Compliance 
Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of two guidances for industry and investigators entitled 
``Safety Reporting Requirements for INDs and BA/BE Studies'' and 
``Safety Reporting Requirements for INDs and BA/BE Studies--Small 
Entity Compliance Guide.'' These guidances are intended to help 
sponsors and investigators comply with the requirements in 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 in the Federal Register on September 29, 2010 (75 
FR 59935). FDA has prepared the Small Entity Compliance Guide in 
accordance with the Small Business Regulatory Enforcement Fairness Act. 
It is intended to help small businesses understand and comply with the 
regulations issued by FDA concerning safety reporting requirements for 
investigational new drug applications (IND) and bioavailability (BA) 
and bioequivalence (BE) studies.

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

ADDRESSES: Submit written requests for single copies of the guidances 
to the Office of Communications, 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 documents.
    Submit electronic comments on the guidances to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-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. 6352, Silver Spring, MD 20993-0002, 301-
796-4836; or Stephen Ripley, 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 two guidances for industry 
and investigators entitled ``Safety Reporting Requirements for INDs and 
BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE 
Studies--Small Entity Compliance Guide.'' These guidances are intended 
to help sponsors and investigators comply with the requirements for IND 
safety reporting and safety reporting for BA and BE studies. In 
addition, the Small Entity Compliance Guide is intended to help small 
businesses understand and comply with the regulations issued by FDA 
concerning the safety reporting requirements for INDs and BA/BE 
studies. FDA has prepared the Small Entity Compliance Guide in 
accordance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act.
    On September 29, 2010, FDA published a final rule amending the IND 
safety reporting requirements under 21 CFR part 312 and adding safety 
reporting requirements for persons conducting BA and BE studies under 
21 CFR part 320. The requirements in the final rule are intended to 
improve the utility and quality of safety reports, expedite and 
strengthen FDA's ability to review critical safety information, and 
better protect human subjects enrolled in clinical trials. FDA also 
published a draft guidance entitled ``Safety Reporting Requirements for 
INDs and BA/BE Studies'' on September 29, 2010 (75 FR 60129), and the 
public was provided with an opportunity to comment on it until December 
28, 2010. FDA carefully considered all of the comments received in 
developing the final guidance. The final guidance includes 
clarifications and additional detail regarding the draft guidance 
topics as well additional information on safety reporting issues raised 
in the comments.
    The final guidance entitled ``Safety Reporting Requirements for 
INDs and BA/BE Studies'' contains the definitions used for IND safety 
reporting, makes recommendations on 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 Small Entity Compliance Guide provides answers to many 
frequently asked questions FDA has received from investigators and 
sponsors regarding the safety reporting requirements that are 
applicable to small entities.
    In addition, on June 7, 2011, the Agency published a guidance 
describing enforcement discretion with the reporting requirements until 
September 28, 2011, to allow sponsors additional time to make process 
changes to implement the final rule (76 FR 32863; June 7, 2011). At 
this time, the Agency is withdrawing this guidance.
    These guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidances represent 
the Agency's current thinking on safety reporting requirements for IND 
and BA/BE studies. They do not create or confer any rights for or on 
any person and do 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 either written comments regarding 
these documents to the Division of Dockets

[[Page 75440]]

Management (see ADDRESSES) or electronic comments to http://www.regulations.gov. It is only necessary to send one set of 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, 
and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    These guidances refer to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in these guidances have been approved under 
OMB control number 0910-0672.

IV. Electronic Access

    Persons with access to the Internet may obtain the documents at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30651 Filed 12-19-12; 8:45 am]
BILLING CODE 4160-01-P


