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4399

Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Notices

Total ..........................................................................................................

Written comments and
recommendations concerning the
proposed information collection should
be sent by February 26, 2010 to:
SAMHSA Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503; due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, respondents are encouraged to
submit comments by fax to: 202–395–
5806.
Dated: January 19, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–1572 Filed 1–26–10; 8:45 am]

Responses
per
respondent

Hours per
response

........................

........................

Number of
respondents

Type of respondent

42,750

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–10BA]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 or send
comments to Maryam Daneshvar, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an e-mail to omb@cdc.gov.

6,662.50

partners. Interventions developed for
gay men may not be relevant or
appropriate for men who have sex with
men and women (MSMW), many of
whom do not self-identify as gay and
who may need different prevention
strategies for their male and female
partners. No interventions in the
scientific literature with demonstrated
efficacy in reducing HIV-related sexual
risk behaviors have been developed and
evaluated specifically for AfricanAmerican MSMW. The proposed study
is essential for developing effective HIV/
AIDS prevention interventions for atrisk African-American MSMW and for
informing policies and programs that
will more effectively protect them and
their partners from infection.
The purpose of the proposed study is
to develop and pilot-test three novel
behavioral interventions to reduce
sexual risk for HIV infection and
transmission among African-American
MSMW who do not inject drugs.
Eligible respondents will be recruited
using chain referral sampling
techniques. Three study sites (Public
Health Management Corporation
(PHMC), Nova Southeastern University,
and California State University (CSU) at
Dominguez Hills) will use a randomized
controlled trial to evaluate the
effectiveness of the intervention.
Respondents will be reimbursed up to a
total of $300 for their time and for
completing all data collection forms. If
these interventions are found to be
effective, organizations that implement
risk-reduction interventions will be able
to use the curricula to intervene with
this population more successfully.
Ultimately, the beneficiary of this data
collection will be African-American
MSMW at risk for HIV. There is no cost
to respondents other than their time.

Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection 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
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Development and Testing of an HIV
Prevention Intervention Targeting Black
Bisexually-Active Men—new—National
Center for HIV/AIDS, Viral Hepatitis,
STD and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).

BILLING CODE 4162–20–P

Total annual
burden hours

Background and Brief Description
African Americans continue to be
disproportionately affected by HIV/
AIDS. Results from the National HIV
Behavioral Surveillance Project
published in the June 2006 Morbidity
and Mortality Weekly Reports showed
that during 2001–2004, although
African-Americans accounted for
approximately 13 percent of the
population, they accounted for the
majority (51 percent) of HIV/AIDS
diagnoses in 33 states. Black men who
have sex with men (MSM) have been
identified as the population segment
with the highest rates of HIV infection
in the U.S. and as a population in need
of new HIV prevention interventions.
Previous research indicates that 20% to
40% of Black MSM also have female sex

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ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of
respondents

Type of respondent

Form name

Prospective Participant .....................
Enrolled Participant ...........................
Enrolled Participant-PHMC ...............
Enrolled Participant-Nova .................
Enrolled Participant-CSU ..................
Enrolled Participant-PHMC ...............
Enrolled Participant-Nova .................

Screening Instrument .......................
Locator Form ....................................
Baseline Assessment .......................
Baseline Assessment .......................
Baseline Assessment .......................
Acceptability Survey .........................
Acceptability Survey .........................

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Number of responses per
respondent

1,250
750
250
240
260
250
240

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1
1
1
1
1
6
1

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Average burden per
response
(in hours)
5/60
10/60
1
1
1
10/60
10/60

Total annual
burden
(in hours)
104
125
250
240
260
250
40

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Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Notices
ESTIMATE OF ANNUALIZED BURDEN TABLE—Continued
Type of respondent

Enrolled
Enrolled
Enrolled
Enrolled
Enrolled
Enrolled
Enrolled

Number of responses per
respondent

Average burden per
response
(in hours)

Total annual
burden
(in hours)

Participant-CSU ..................
Participant-PHMC ...............
Participant-Nova .................
Participant-CSU ..................
Participant-PHMC ...............
Participant-Nova .................
Participant-CSU ..................

Acceptability Survey .........................
Immediate Follow-Up Assessment ..
Immediate Follow-Up Assessment ..
Immediate Follow-Up Assessment ..
3 month Follow-Up Assessment ......
3 month Follow-Up Assessment ......
3 month Follow-Up Assessment ......

260
225
216
234
200
192
208

1
1
1
1
1
1
1

10/60
30/60
30/60
30/60
1
1
1

43
113
108
117
200
192
208

Total ...........................................

...........................................................

........................

........................

........................

2,250

Dated: January 20, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–1650 Filed 1–26–10; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0026]

Draft Guidance for Industry on
Assessment of Abuse Potential of
Drugs; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

srobinson on DSKHWCL6B1PROD with NOTICES

Number of
respondents

Form name

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Assessment of Abuse
Potential of Drugs.’’ This draft guidance
is intended to assist sponsors who are
developing drug and other medical
products with the potential for abuse
that may need to be scheduled under
the Controlled Substances Act. Drugs
with abuse potential generally include
drugs that affect the central nervous
system, drugs that are chemically or
pharmacologically similar to other drugs
with known abuse potential, and drugs
that produce psychoactive effects such
as sedation, euphoria, or mood 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 March 29, 2010.
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

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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.
FOR FURTHER INFORMATION CONTACT:
Corinne P. Moody, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5144,
Silver Spring, MD 20993–0002, 301–
796–5402.
SUPPLEMENTARY INFORMATION:

I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Assessment of Abuse Potential of
Drugs.’’ Under the Federal Food, Drug,
and Cosmetic Act, an abuse potential
assessment is part of the general
evaluation of the safety and efficacy of
a drug to be used under medical
supervision. If a drug has abuse
potential, the Secretary of Health and
Human Services (HHS) is required
under the Controlled Substances Act of
1970 (CSA) to make a recommendation
for scheduling to the Drug Enforcement
Administration (DEA). The regulatory
responsibilities for this process are
described in Title 21 United States Code
(U.S.C.) 811, with delegation of
authority to FDA from HHS. The
Controlled Substance Staff (CSS) of FDA
performs the scientific evaluation of the
abuse potential of a drug for HHS, in
consultation with the National Institute
on Drug Abuse (NIDA), as described in
a Memorandum of Understanding
(MOU) of March 8, 1985 (50 FR 9518).

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When a sponsor submits a marketing
application for a drug with abuse
potential to FDA for review, the sponsor
is required to propose a CSA schedule
and provide a basis for this proposal (21
CFR 314.50(d)(5)(vii)). The sponsor’s
proposal is considered by the agency
during its evaluation of the drug’s abuse
potential. At the time a marketing
application is submitted to FDA for
review, the sponsor signs a statement
agreeing not to market the product until
the DEA makes a final scheduling
decision.
FDA prepares a scientific analysis
with a recommendation for scheduling,
based on the submission of the sponsor
that includes a scientific and medical
evaluation of all relevant and available
data, an assessment of the public health
risk, and a proposal for scheduling. This
recommendation is forwarded to DEA
for consideration in the decision on
final scheduling of the drug. Scheduling
results in specific regulatory
requirements relating to the drug’s
labeling, prescribing, advertising,
manufacturing, promotion, marketing,
and use in the practice of medicine. Not
following these requirements can result
in criminal penalties.
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 assessing abuse potential of drugs. 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. 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

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