Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 34021 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Activity name Number of 

respondents 

Total burden 

hours 

Average 

hourly 

wage rate* 

Total cost 

burden 

Key Informant Interviews with EHC Stakeholder Group Members ................. 2 2 43.52 87 

Key Informant Interviews with EHC Program Users and Stakeholders .......... 19 19 46.73 888 

Online Survey with EHC Program Users and Stakeholders ........................... 170 43 46.73 2,009 

Key Informant Interviews with EHC Program Users and Stakeholders to Develop Cases ................................................................................................. 25 25 46.73 1,168 

Appreciative Inquiry Workshop ........................................................................ 20 120 51.14 6,137 

Total .......................................................................................................... 344 246 na 12,297 

* Wage rates were calculated using the following data: (1) For the Governance Interviews and the Online Survey with EHC Research Centers 

Staff the hourly rate is a weighted average for physicians ($58.76 per hour) and medical and health services managers ($37.82); (2) for the Governance Interviews with EHC Stakeholder Group Members the hourly rate is the rate for average for medical and health services managers 

($37.82); (3) for the Governance Interviews and the Online Survey with EHC Program Users and Stakeholders the hourly rate is a weighted average for physicians ($58.76 per hour), general and operations managers ($43.52 per hour), medical and health services managers ($37.82 per 

hour), and social and community service managers ($24.73 per hour); (4) for the Workshop the hourly rate is a weighted average for physicians 

($58.76 per hour) and general and operations managers ($43.52 per hour) from the mean of the average wages, National Compensation Survey: 

Occupational Wages in the United States 2006, U.S. Department of Labor, Bureau of Labor Statistics. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated cost of 

this one year data collection for the 

evaluation of the EHC program, 

including the cost of developing the 

methodology and data collection 

instruments, collecting and analyzing 

the data, publishing the results, etc. The 

work will be carried out by IMPAQ 

International and Abt Associates under 

contract to the Agency for Healthcare 

Research and Quality. 

EXHIBIT 3—ESTIMATED ANNUAL COST

TO THE FEDERAL GOVERNMENT

Cost component Total cost 

Project Development ................ $137,901 

Data Collection Activities .......... 179,172 

Data Processing and Analysis 170,577 

Publication of Results ............... 63,686 

Project Management ................ 97,236 

Total ................................... 648,572 

* Please note the costs include fully loaded 

costs (overhead, G&A). 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: July 2, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–16568 Filed 7–13–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0212] 

Draft Guidance for Industry on 

‘‘Incorporation of Physical-Chemical 

Identifiers into Solid Oral Dosage Form 

Drug Products for Anticounterfeiting,’’ 

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 entitled ‘‘Incorporation of 

Physical-Chemical Identifiers into Solid 

Oral Dosage Form Drug Products for 

Anticounterfeiting.’’ This draft guidance 

provides recommendations to 

pharmaceutical manufacturers on 

design considerations for incorporating 

physical-chemical identifiers (PCIDs) 

into solid oral dosage forms (SODFs), 

supporting documentation to be 

submitted in new drug applications 

(NDAs) and abbreviated new drug 

applications (ANDAs) to address the 

proposed incorporation of PCIDs in 

SODFs, supporting documentation to be 

submitted in postapproval submissions 

to report or request approval to 

incorporate PCIDs into SODFs, and 

procedures for reporting or requesting 

approval to incorporate PCIDs into 

SODFs as a postapproval change. This 

draft guidance also provides our 

recommendations regarding evaluation 

of toxicological and other concerns for 

PCIDs that are incorporated into 

packaging and labeling and procedures 

for reporting or requesting approval to 

add PCIDs to packaging and containers 

as a postapproval change. 

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 

written or electronic comments on the 

draft guidance by October 13, 2009. 

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. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft 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 draft guidance 

document. 

mstockstill on DSKH9S0YB1PROD with NOTICES

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 

mstockstill on DSKH9S0YB1PROD with NOTICES