Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application; Availability, 34023-34024 [E9-16738]

Download as PDF Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices C. Eligibility Information This award will be made to HCRI. B. Research Objectives mstockstill on DSKH9S0YB1PROD with NOTICES mind, it is imperative that the risks and benefits of continued clopidogrel use be evaluated to determine, with greater precision, the optimal duration of dual anti-platelet therapy. This trial will be conducted with the unprecedented cooperation of four device manufacturers and two drug manufacturers under the direction of HCRI. B. Length of Support The total project period for the application submitted in response to this funding opportunity may not exceed 2 years. The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by HCRI in areas representing the investigators’ specific interests and competencies based on the mission of FDA. The development of the DAPT trial represents an important and critical new paradigm for FDA and the medical product development community —having identified a critical public health issue in a combination product that impacts hundreds of thousands of American patients, the device and drug industries are collaborating together to address this question with a single trial. The advantages of this concerted effort are obvious—obtaining an answer more quickly and with fewer resources expended. The study is unprecedented in the level of cooperation, both internal and external, that is required. FDA awards R01 grants to institutions/organizations of all types. This mechanism allows the program directors/principal investigators (PDs/ PIs) to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/ organization. One of OCPP’s mandates is to identify and promote the development of collaborative partnerships and support mechanisms of innovative trial design. Innovative clinical trial design may make it possible to develop accepted protocols for smaller but smarter trials or trials that can be conducted with collaboration of multiple device and drug manufacturers. The development of the DAPT trial represents an important and critical new paradigm for FDA. When a critical public health issue is identified in a combination product that impacts thousands of American patients, the concerted effort of multiple parts of the agency can bring the members of the regulated industry and clinical community to develop a clinical trial that will provide the answers needed by practicing physicians. VerDate Nov<24>2008 17:50 Jul 13, 2009 Jkt 217001 II. Award Information/Funds Available A. Award Amount The total amount of funding that the agency expects to award through this announcement is $1.5 million. There will be one award. III. How to Submit a Paper Application To submit a paper application in response to this FOA, applicants should first review the full announcement located at https://www.fda.gov/oc/ initiatives/criticalpath/. Persons interested in applying for a grant may obtain an application form at https:// grants.nih.gov/grants/forms.htm. For all paper submissions, the following steps are required: • Step 1: Obtain a Dun and Bradstreet (DUNS) Number • Step 2: Register With Central Contractor Registration • Step 3: Register With Electronic Research Administration (eRA) Commons Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/ organization_registration.jsp. Step 3, in detail, can be found at https:// commons.era.nih.gov/commons/ registration/registrationInstructions.jsp. After you have followed these steps, submit paper applications to: Vieda Hubbard (see FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT). Dated: July 8, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–16695 Filed 7–13–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0434 (Formerly Docket No. 2007D–0386)] Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00036 Fmt 4703 Sfmt 4703 34023 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.’’ This document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-thecounter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by FDA’s Center for Food Safety and Applied Nutrition on adverse event reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Kathleen Frost, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4312, Silver Spring, MD 20993–0002, 301– 796–2380. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.’’ Public Law 109–462, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, enacted on December 22, 2006, required FDA to issue guidance on the minimum data elements that should be included in a serious adverse E:\FR\FM\14JYN1.SGM 14JYN1 mstockstill on DSKH9S0YB1PROD with NOTICES 34024 Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices event report (section 2(e)(3)). The guidance document provides information on the following topics: (1) The minimum data elements that should be included in a serious adverse event report, (2) the label that should be included with the report, (3) reporting formats for paper and electronic submissions, and (4) how and where to submit the reports. Public Law 109–462 amends the Federal Food, Drug, and Cosmetic Act (the act) to add safety reporting requirements for nonprescription drug products that are marketed without an approved application. In accordance with section 760(b) of the act (21 U.S.C. 379aa), the manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug marketed in the United States without an approved application (referred to as the ‘‘responsible person’’) must submit to FDA any report of a serious adverse event associated with such drug when used in the United States, accompanied by a copy of the label on or within the retail package of such drug. In addition, the responsible person must submit followup reports of new medical information related to a submitted serious adverse event report that is received within 1 year of the initial report (section 760(c)(2) of the act). Public Law 109–462 also requires certain postmarketing safety report!s for dietary supplements. In the Federal Register of October 15, 2007 (72 FR 58316), FDA announced the availability of a draft guidance of the same title. FDA received several comments on the draft guidance and considered those comments when finalizing the guidance. The guidance announced in this notice finalizes the draft guidance dated October 2007. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on postmarketing adverse event reporting for nonprescription human drug products marketed without an approved application. 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. Paperwork Reduction Act of 1995 This 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 collections of information in VerDate Nov<24>2008 17:50 Jul 13, 2009 Jkt 217001 this guidance have been approved under OMB Control No. 0910–0636. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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. 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: July 8, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–16738 Filed 7–13–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0372] (Formerly Docket No. 2007D–0388) Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ‘‘Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.’’ The document provides guidance to the dietary supplement industry for complying with the serious adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Consumer Protection Act (the DSNDCPA). Separate guidance, issued by FDA’s Center for Drug Evaluation and Research, on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register. DATES: Submit written or electronic comments on the guidance at any time. ADDRESSES: Submit written comments on the guidance 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 guidance to https://www.regulations.gov. Submit written requests for single copies of the guidance to the Office of Nutrition, Labeling, and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20750. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Vasilios Frankos,Center for Food Safety and Applied Nutrition (HFS–810), Food and Drug Administration,5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2375. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 15, 2007 (72 FR 58313), FDA announced the availability of a draft guidance entitled ‘‘Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act’’ and gave interested parties an opportunity to submit comments by December 14, 2007. The agency reviewed and evaluated these comments and has modified the guidance where appropriate. The guidance contains questions and answers relating to the new requirements under the DSNDCPA, concerning the mandatory reporting to FDA of serious adverse events associated with dietary supplements, the minimum data elements to be submitted in such reports, and records of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor. FDA is issuing this guidance as level 1 guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the E:\FR\FM\14JYN1.SGM 14JYN1

Agencies

[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Notices]
[Pages 34023-34024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16738]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0434 (Formerly Docket No. 2007D-0386)]

Guidance for Industry on Postmarketing Adverse Event Reporting
for Nonprescription Human Drug Products Marketed Without an Approved
Application; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Postmarketing
Adverse Event Reporting for Nonprescription Human Drug Products
Marketed Without an Approved Application.'' This document provides
guidance to industry on postmarketing serious adverse event reporting
for nonprescription (over-the-counter (OTC)) human drugs marketed
without an approved application. It gives guidance on the minimum data
elements that should be included in a serious adverse event report, the
label that should be included with the report, reporting formats for
paper and electronic submissions, and how and where to submit the
reports. Separate guidance, issued by FDA's Center for Food Safety and
Applied Nutrition on adverse event reporting for dietary supplements,
is announced elsewhere in this issue of the Federal Register.

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

ADDRESSES: Submit written requests for single copies of this 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. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Kathleen Frost, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4312, Silver Spring, MD 20993-0002, 301-
796-2380.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry
entitled ``Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products Marketed Without an Approved Application.'' Public
Law 109-462, the Dietary Supplement and Nonprescription Drug Consumer
Protection Act, enacted on December 22, 2006, required FDA to issue
guidance on the minimum data elements that should be included in a
serious adverse

[[Page 34024]]

event report (section 2(e)(3)). The guidance document provides
information on the following topics: (1) The minimum data elements that
should be included in a serious adverse event report, (2) the label
that should be included with the report, (3) reporting formats for
paper and electronic submissions, and (4) how and where to submit the
reports.
Public Law 109-462 amends the Federal Food, Drug, and Cosmetic Act
(the act) to add safety reporting requirements for nonprescription drug
products that are marketed without an approved application. In
accordance with section 760(b) of the act (21 U.S.C. 379aa), the
manufacturer, packer, or distributor whose name appears on the label of
a nonprescription drug marketed in the United States without an
approved application (referred to as the ``responsible person'') must
submit to FDA any report of a serious adverse event associated with
such drug when used in the United States, accompanied by a copy of the
label on or within the retail package of such drug. In addition, the
responsible person must submit followup reports of new medical
information related to a submitted serious adverse event report that is
received within 1 year of the initial report (section 760(c)(2) of the
act). Public Law 109-462 also requires certain postmarketing safety
report!s for dietary supplements.
In the Federal Register of October 15, 2007 (72 FR 58316), FDA
announced the availability of a draft guidance of the same title. FDA
received several comments on the draft guidance and considered those
comments when finalizing the guidance. The guidance announced in this
notice finalizes the draft guidance dated October 2007.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on postmarketing adverse event reporting for
nonprescription human drug products marketed without an approved
application. 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. Paperwork Reduction Act of 1995

This 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
collections of information in this guidance have been approved under
OMB Control No. 0910-0636.

III. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.

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: July 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16738 Filed 7-13-09; 8:45 am]
BILLING CODE 4160-01-S

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