Proposed Data Collections Submitted for Public Comment and Recommendations, 4399-4400 [2010-1650]

Download as PDF 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 ESTIMATE OF ANNUALIZED BURDEN TABLE Number of respondents srobinson on DSKHWCL6B1PROD with NOTICES 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 ......................... VerDate Nov<24>2008 16:22 Jan 26, 2010 Jkt 220001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Number of responses per respondent 1,250 750 250 240 260 250 240 E:\FR\FM\27JAN1.SGM 1 1 1 1 1 6 1 27JAN1 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 4400 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 respondents Form name 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. srobinson on DSKHWCL6B1PROD with NOTICES ACTION: 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 VerDate Nov<24>2008 16:22 Jan 26, 2010 Jkt 220001 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 https:// 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). PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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 E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 75, Number 17 (Wednesday, January 27, 2010)]
[Notices]
[Pages 4399-4400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1650]


-----------------------------------------------------------------------

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.
    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).

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 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 
African-American MSMW. The proposed study is essential for developing 
effective HIV/AIDS prevention interventions for at-risk 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.

                                       Estimate of Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden   Total annual
      Type of respondent            Form name        Number of     responses per   per response     burden  (in
                                                    respondents     respondent      (in hours)        hours)
----------------------------------------------------------------------------------------------------------------
Prospective Participant.......  Screening                  1,250               1            5/60             104
                                 Instrument.
Enrolled Participant..........  Locator Form....             750               1           10/60             125
Enrolled Participant-PHMC.....  Baseline                     250               1               1             250
                                 Assessment.
Enrolled Participant-Nova.....  Baseline                     240               1               1             240
                                 Assessment.
Enrolled Participant-CSU......  Baseline                     260               1               1             260
                                 Assessment.
Enrolled Participant-PHMC.....  Acceptability                250               6           10/60             250
                                 Survey.
Enrolled Participant-Nova.....  Acceptability                240               1           10/60              40
                                 Survey.

[[Page 4400]]

 
Enrolled Participant-CSU......  Acceptability                260               1           10/60              43
                                 Survey.
Enrolled Participant-PHMC.....  Immediate Follow-            225               1           30/60             113
                                 Up Assessment.
Enrolled Participant-Nova.....  Immediate Follow-            216               1           30/60             108
                                 Up Assessment.
Enrolled Participant-CSU......  Immediate Follow-            234               1           30/60             117
                                 Up Assessment.
Enrolled Participant-PHMC.....  3 month Follow-              200               1               1             200
                                 Up Assessment.
Enrolled Participant-Nova.....  3 month Follow-              192               1               1             192
                                 Up Assessment.
Enrolled Participant-CSU......  3 month Follow-              208               1               1             208
                                 Up Assessment.
                                                 ---------------------------------------------------------------
    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
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