Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 34023 

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. Research Objectives 

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. 

C. Eligibility Information 

This award will be made to HCRI. 

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. 

B. Length of Support 

The total project period for the 

application submitted in response to 

this funding opportunity may not 

exceed 2 years. 

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 http://www.fda.gov/oc/ 

initiatives/criticalpath/. Persons 

interested in applying for a grant may 

obtain an application form at http:// 

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 http://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: 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-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 http:// 

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 

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 

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 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

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 

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 http://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 

mstockstill on DSKH9S0YB1PROD with NOTICES