34022 Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 

FOR FURTHER INFORMATION CONTACT: John 

L. Smith, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10993 New Hampshire 

Ave., Building 21, rm. 2619, Rockville, 

MD 20857, 301–796–1757. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Incorporation of Physical-Chemical 

Identifiers into Solid Oral Dosage Form 

Drug Products for Anticounterfeiting.’’ 

Pharmaceutical manufacturers aiming to 

thwart drug product counterfeiting have 

been investigating readily available 

technologies to make drug products 

more difficult to duplicate. One 

approach that pharmaceutical 

manufacturers appear to be considering 

involves adding a trace amount of an 

inactive ingredient(s) to an existing 

section of the dosage form. A unique 

physical-chemical characteristic of that 

ingredient makes it possible to detect 

and authenticate legitimate dosage 

forms and identify counterfeits. 

This draft guidance provides 

recommendations to pharmaceutical 

manufacturers on the following topics: 

(1) Design considerations for 

incorporating PCIDS into SODFs, (2) 

supporting documentation to be 

submitted with NDAs and ANDAs to 

address the proposed incorporation of 

PCIDs in SODFs, (3) supporting 

documentation to be submitted in 

postapproval submissions to report or 

request approval to incorporate PCIDs 

into SODFs, and (4) procedures for 

reporting or requesting approval to 

incorporate PCIDs into SODFs as a 

postapproval change. This draft 

guidance also provides our 

recommendations regarding: (1) 

Evaluation of toxicological and other 

concerns for PCIDs that are incorporated 

into packaging and labeling and (2) 

procedures for reporting or requesting 

approval to add PCIDs to packaging and 

containers as a postapproval change. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Incorporation of Physical-Chemical 

Identifiers into Solid Oral Dosage Form 

Drug Products for Anticounterfeiting.’’ 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. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information 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 

documentation in premarketing 

regulatory submissions recommended 

for applicants incorporating PCIDs into 

SODFs would be covered under 21 CFR 

314.50 and 314.94, and the 

documentation in postapproval 

regulatory submissions would be 

covered under 21 CFR 314.70. This 

information collection is approved by 

OMB under OMB control number 0910– 

0001. 

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/cder/guidance/

index.htm or http://www.regulations.

gov. 

Dated: July 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16612 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–2009–N–0313] 

Dual Antiplatelet Therapy Trial: 

Research Project Grant (R01) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of grant funds for the 

support of the Office of Critical Path 

Programs (OCPP). The goal of the Dual 

Antiplatelet Therapy (DAPT) Trial is to 

solicit a sole source grant application 

from Harvard Clinical Research Institute 

(HCRI) that proposes to provide funding 

in support of a dual antiplatelet therapy 

clinical trial being conducted by HCRI. 

DATES: Important dates are as follows: 

1. The application due date is August 

12, 2009. 

2. The anticipated start date is in 

September 2009. 

3. The opening date is July 14, 2009. 

4. The expiration date is in May 2010. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

Nancy Stanisic, Office of Critical Path 

Programs (HF–18), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

1660. 

Vieda Hubbard, Office of Acquisitions 

and Grants Services, (HFA–500), 

Food and Drug Administration, 

5630 Fishers Lane, Rockville, MD 

20857, 301–827–7177. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA located at http:// 

www.fda.gov/oc/initiatives/criticalpath/ 

. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

Request for Applications (RFA) Number: 

RFA–FD–09–016 

Catalog of Federal Domestic Assistance 

Number: 93.103 

A. Background 

OCPP is soliciting a sole source grant 

application from HCRI that proposes to 

provide funding in support of a dual 

antiplatelet therapy clinical trial being 

conducted by HCRI. 

Given the lack of randomized data, 

there is considerable uncertainty in the 

medical community about the optimal 

duration of dual antiplatelet therapy 

following Percutaneous Cardiac 

Intervention. It is unclear as to whether 

the duration of dual antiplatelet therapy 

in patients receiving Drug Eluting Stents 

(DES) should be 3 to 6 months (as was 

prescribed in the pivotal DES 

randomized trials conducted for 

premarket approval), 12 months (as per 

the American College of Cardiology/ 

American Heart Association/Society for 

Cardiac Angiography and Interventions 

guidelines), or even longer. It is also 

unknown whether the presumed benefit 

of extended dual antiplatelet therapy is 

specific to DES or whether non-Acute 

Coronary Syndrome patients treated 

with BMS (e.g. stable angina) may also 

benefit from extended dual antiplatelet 

therapy. With these considerations in 

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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 

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