Agency Forms Undergoing Paperwork Reduction Act Review, 45215-45216 [E9-21037]
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45215
Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices
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
Adult male and female (age 18+ years) screened ......................................................................
Adult male and female (age 18+ years) Pre/Post Evaluation survey .........................................
Adult male and female (age 18+ years) household visit .............................................................
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
mstockstill on DSKH9S0YB1PROD with NOTICES
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
17:18 Aug 31, 2009
Jkt 217001
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
[30Day–09–09AF]
VerDate Nov<24>2008
comments should be received within 30
days of this notice.
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
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
425
360
36
Number of responses per
respondent
1
2
1
Average
burden per
response
(in hours)
5/60
15/60
1
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
E:\FR\FM\01SEN1.SGM
01SEN1
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
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.
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
ESTIMATE OF ANNUALIZED BURDEN TABLE
Form name
Pharmacist ......................................................
Pharmacy telephone screening and enrollment form.
Pharmacy staff baseline survey .....................
Pharmacy staff six monthly survey ................
Pharmacy staff exit survey .............................
Pharmacy staff monthly survey ......................
Syringe sales and referral log ........................
Pharmlink Participant Baseline Survey ..........
Pharmacist and Pharmacy Technician ...........
Pharmacist and Pharmacy Technician ...........
Pharmacist and Pharmacy Technician ...........
Pharmacist ......................................................
Pharmacy Technician .....................................
Syringe-customer study participant ................
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.
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,
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Nov<24>2008
17:18 Aug 31, 2009
Jkt 217001
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
No. of
responses per
respondent
No. of
respondents
Respondent
Average
burden per
response
(in hours)
8
1
10/60
48
48
48
12
12
221
1
2
1
10
300
1
20/60
20/60
20/60
10/60
5/60
30/60
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:
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Pages 45215-45216]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21037]
-----------------------------------------------------------------------
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 e-mail
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-drug-using 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-drug-using 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) injection-drug-using
syringe customers will
[[Page 45216]]
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
injection-drug-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 injection-drug-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
----------------------------------------------------------------------------------------------------------------
Average
No. of No. of burden per
Respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Pharmacist......................... Pharmacy telephone 8 1 10/60
screening and enrollment
form.
Pharmacist and Pharmacy Technician. Pharmacy staff baseline 48 1 20/60
survey.
Pharmacist and Pharmacy Technician. Pharmacy staff six monthly 48 2 20/60
survey.
Pharmacist and Pharmacy Technician. Pharmacy staff exit survey. 48 1 20/60
Pharmacist......................... Pharmacy staff monthly 12 10 10/60
survey.
Pharmacy Technician................ Syringe sales and referral 12 300 5/60
log.
Syringe-customer study participant. Pharmlink Participant 221 1 30/60
Baseline Survey.
----------------------------------------------------------------------------------------------------------------
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
