Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability, 60129-60130 [2010-24295]

Download as PDF 60129 Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Notices Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Cathrine Sasek, Coordinator, Science Education Program, Office of Science Policy and Communications, National Institute on Drug Abuse, 6001 Executive Blvd, Room 5237, Bethesda, MD 20892, or call non-toll-free number (301) 443– 6071; fax (301) 443–6277; or by e-mail to csasek@nida.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. Dated: September 22, 2010. Mary Affeldt, Executive Officer, (OM Director, NIDA). [FR Doc. 2010–24400 Filed 9–28–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: Required Data Elements for Paternity Establishment Affidavits. OMB No.: 0970–0171. Description: Section 466(a)(5)(C)(iv) of the Social Security Act the Act) requires States to develop and use an affidavit for the voluntary acknowledgement of paternity. The affidavit for the voluntary acknowledgement of paternity must include the minimum requirements specified by the Secretary under section 452(a)(7) of the Act. The affidavits will be used by hospitals, birth record agencies, and other entities participating in the voluntary paternity establishment program. Respondents: State and Tribal IV–D agencies, hospitals, birth record agencies and other entities participating in the voluntary paternity establishment program. ANNUAL BURDEN ESTIMATES Number of respondents erowe on DSK5CLS3C1PROD with NOTICES Instrument Estimated Total Annual Burden Hours: 0 In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the VerDate Mar<15>2010 15:17 Sep 28, 2010 Jkt 220001 Number of responses per respondent Average burden hours per response Total burden hours agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: September 22, 2010. Robert Sargis, Reports Clearance Officer. HHS. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 [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: ACTION: [FR Doc. 2010–24212 Filed 9–28–10; 8:45 am] BILLING CODE 4184–01–P Food and Drug Administration Food and Drug Administration, Notice. 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 SUMMARY: E:\FR\FM\29SEN1.SGM 29SEN1 60130 Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Notices erowe on DSK5CLS3C1PROD with NOTICES 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 selfaddressed 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 https:// 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 VerDate Mar<15>2010 15:17 Sep 28, 2010 Jkt 220001 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. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// 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] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Basic and Translational Oncology P01. Date: September 30–October 1, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Shakeel Ahmad, PhD, Scientific Review Officer, Research Programs E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[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.

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

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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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]
BILLING CODE 4160-01-P
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