Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45215 

Background and Brief Description 

This project seeks a one year 

extension of its OMB PRA clearance for 

data collection. Due to early project 

delays in obtaining clearances for data 

collection, the project was unable to 

start as planned and missed evaluating 

one program cycle, with a program cycle 

running for approximately one year. 

This extension is necessary in order to 

complete the project’s original design of 

evaluating three program cycles of the 

SAIFE program as implemented in the 

State of North Carolina. An extension 

will allow completion of the evaluation 

of the third and final cycle of the 

program. 

This project will use data from inperson interviews, paper and telephone 

surveys to assess the effectiveness of the 

Smoke Alarm Installation and Fire 

Safety Education (SAIFE) program and 

its efficacy in delivering fire safety 

information. The data will be collected 

from a convenience sample of adults 18 

years of age or older who volunteer to 

participate in the SAIFE program. A 

total of 360 households will complete 

the evaluation each year of the data 

collection for a mass total of 1080 

households over the next three years. 

Participants will be asked to complete a 

15-minute survey at two points, once 

immediately before the intervention and 

then 6 months afterwards. The survey 

will assess outcome measures including, 

but not limited to, changes in 

knowledge, attitudes, beliefs, and 

behaviors regarding various aspects of 

fire safety and prevention; changes in 

reported residential fire-related injuries 

and deaths; increased or decreased 

presence of functioning smoke alarms; 

and the costs associated with the SAIFE 

intervention. The evaluation will 

measure these changes across time, 

between groups and within groups, 

among communities that will receive 

the SAIFE intervention. 

CDC programs are currently funded in 

16 States to provide for home 

installation of smoke alarms plus 

general fire safety education in 

households at high risk for fire and fire 

related injury and death. Programs of 

this type are intended to prevent fire 

related injury and mortality, but have 

not been studied scientifically to assess 

their impact on fire-related injury 

outcomes. The proposed study 

represents the first formal effort to 

evaluate the effectiveness and cost 

implications of the SAIFE program as 

implemented in North Carolina. The 

data collected in this study will have 

the potential to inform other smoke 

alarm installation programs, as well as 

indicate future priorities in prevention 

and preparedness for residential 

household fires. The only cost to the 

participant is the time involved to 

complete the surveys. The total 

estimated annualized burden hours are 

251. 

ESTIMATE OF ANNUALIZED BURDEN TABLE

Type of 

respondents 

Number of 

respondents 

Number of responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Adult male and female (age 18+ years) screened ...................................................................... 425 1 5/60 

Adult male and female (age 18+ years) Pre/Post Evaluation survey ......................................... 360 2 15/60 

Adult male and female (age 18+ years) household visit ............................................................. 36 1 1 

Dated: August 26, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–21041 Filed 8–31–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–09AF] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Evaluation of Pharmacy Syringe 

Access Linked to HIV Testing for 

Injection Drug Users in New York City 

(Pharm-HIV)—New—National Center 

for HIV/AIDS, Viral Hepatitis, STD, and 

TB Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

HIV continues to be one of the leading 

causes of illness and death in the US, 

among injection drug users who are at 

high risk of acquiring HIV infection. 

HIV testing may not be readily 

accessible to this population in areas 

where they frequent. The New York 

State Legislature established an 

Expanded Syringe Access 

Demonstration Program (ESAP) in 2001 

in New York City. ESAP makes sterile 

syringes available for injection drug 

users through participating pharmacies, 

in order to help reduce the burden of 

HIV. The regular contact between 

pharmacists and their injection-drugusing syringe customers through ESAP 

paves the way for pharmacies to act as 

access points to health and social 

services among IDU customers. The 

expansion of pharmacy services to 

include referrals for injection-drugusing syringe customers is based on the 

successes of ESAP, which provides 

many services beyond syringe exchange. 

The New York Academy of Medicine 

(NYAM) has access to the ESAP list of 

pharmacies. NYAM will identify 12 

ESAP pharmacies in East Harlem, New 

York City that are situated within 

predefined target neighborhoods where 

there are high levels of injection drug 

use. NYAM study staff will screen the 

ESAP pharmacies for eligibility by 

calling down a randomly-ordered list of 

ESAP-registered pharmacies and 

enrolling pharmacies willing to 

participate in this study. NYAM 

anticipates that they will have to contact 

24 ESAP-registered pharmacies in the 

first year of the project (one pharmacy 

staff member at each pharmacy) in order 

to identify the 12 that will participate in 

the study. Recruitment of pharmacies 

will occur only during the first year. 

At the 12 ESAP-registered pharmacies 

that join the study, over a three year 

period, 442 adult (age ≥18 yrs) injectiondrug-using syringe customers will 

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45216 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

complete a brief quantitative interview 

after HIV referral or HIV testing is 

offered to them. HIV-seropositive 

injection-drug-using syringe customers 

who are identified during HIV testing 

will be immediately linked to social and 

medical services. Ten of the 12 ESAP 

Pharmacies will provide referrals to 

local HIV testing sites for their injectiondrug-using syringe customers. At these 

ten pharmacies, 40 adult pharmacy staff 

will be surveyed on pharmacy staff 

attitudes and behaviors regarding HIV 

testing and referral. 

The remaining two ESAP pharmacies 

will pilot test the feasibility of offering 

and performing HIV counseling and 

testing in the pharmacy for injectiondrug-using syringe customers. At these 

two pharmacies, 8 adult (age ≥18 yrs) 

pharmacy staff members will be 

surveyed on pharmacy staff attitudes 

and behaviors regarding HIV testing and 

referral. At the 12 pharmacies, 12 

pharmacy staff members (one from each 

pharmacy) will be surveyed monthly to 

track study progress and obstacles to 

completing the study. Twelve pharmacy 

staff members (one from each pharmacy) 

will complete a daily syringe sales and 

referral log. 

There is no cost to the injection drug 

using customers who provide 

information to this study other than 

their time. The total estimated annual 

burden hours are 496 hours. 

ESTIMATE OF ANNUALIZED BURDEN TABLE

Respondent Form name No. of 

respondents 

No. of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Pharmacist ...................................................... Pharmacy telephone screening and enrollment form.8 1 10/60 

Pharmacist and Pharmacy Technician ........... Pharmacy staff baseline survey ..................... 48 1 20/60 

Pharmacist and Pharmacy Technician ........... Pharmacy staff six monthly survey ................ 48 2 20/60 

Pharmacist and Pharmacy Technician ........... Pharmacy staff exit survey ............................. 48 1 20/60 

Pharmacist ...................................................... Pharmacy staff monthly survey ...................... 12 10 10/60 

Pharmacy Technician ..................................... Syringe sales and referral log ........................ 12 300 5/60 

Syringe-customer study participant ................ Pharmlink Participant Baseline Survey .......... 221 1 30/60 

Dated: August 26, 2009. 

Marilyn S. Radke, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–21037 Filed 8–31–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0131] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prescription Drug 

Marketing Act of 1987 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 1, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0435. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Prescription Drug Marketing Act of 

1987; 21 CFR Part 203 (OMB Control 

Number 0910–0435)—Extension 

FDA is requesting OMB approval 

under the Paperwork Reduction Act (44 

U.S.C. 3501–3520) for the reporting and 

recordkeeping requirements contained 

in the regulations implementing the 

Prescription Drug Marketing Act of 1987 

(PDMA) (Public Law 100–293). PDMA 

was intended to ensure that drug 

products purchased by consumers are 

safe and effective, and to avoid an 

unacceptable risk that counterfeit, 

adulterated, misbranded, subpotent, or 

expired drugs are sold. 

PDMA was enacted by Congress 

because there were insufficient 

safeguards in the drug distribution 

system to prevent the introduction and 

retail sale of substandard, ineffective, or 

counterfeit drugs, and that a wholesale 

drug diversion submarket had 

developed that prevented effective 

control over the true sources of drugs. 

Congress found that large amounts of 

drugs had been reimported into the 

United States as U.S. goods returned 

causing a health and safety risk to U.S. 

consumers because the drugs may 

become subpotent or adulterated during 

foreign handling and shipping. Congress 

also found that a ready market for 

prescription drug reimports had been 

the catalyst for a continuing series of 

frauds against U.S. manufacturers and 

had provided the cover for the 

importation of foreign counterfeit drugs. 

Congress also determined that the 

system of providing drug samples to 

physicians through manufacturers’ 

representatives had resulted in the sale 

to consumers of misbranded, expired, 

and adulterated pharmaceuticals. 

The bulk resale of below-wholesale 

priced prescription drugs by health care 

entities for ultimate sale at retail also 

helped to fuel the diversion market and 

was an unfair form of competition to 

wholesalers and retailers who had to 

pay otherwise prevailing market prices. 

FDA is requesting OMB approval for 

the following reporting and 

recordkeeping requirements: 

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