80 FR 27316 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 92 (May 13, 2015)

Page Range		27316-27318
FR Document		2015-11512

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a new information collection request entitled, ``Understanding Barriers and Facilitators to HIV prevention for Men Who Have Sex with Men (MSM)'' to conduct qualitative research with most at risk HIV-negative MSM. The research is intended to understand issues surrounding HIV risk for MSM, identify influences of high risk behaviors and to investigate risk management and resiliency among HIV-negative MSM.

Federal Register, Volume 80 Issue 92 (Wednesday, May 13, 2015)

[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27316-27318]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11512]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-15-15AGK; Docket No. CDC-2015-0032]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention, CDC, Department of 
Health and Human Services, HHS.

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a new information 
collection request entitled, ``Understanding Barriers and Facilitators 
to HIV prevention for Men Who Have Sex with Men (MSM)'' to conduct 
qualitative research with most at risk HIV-negative MSM. The research 
is intended to understand issues surrounding HIV risk for MSM, identify 
influences of high risk behaviors and to investigate risk management 
and resiliency among HIV-negative MSM.

DATES: Written comments must be received on or before July 13, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0032 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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)

[[Page 27317]]

ways to enhance the quality, utility, and clarity of the information to 
be collected; (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; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information.

Proposed Project

    Understanding Barriers and Facilitators to HIV prevention for Men 
Who Have Sex with Men (MSM) (Pulse Study)--New--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention (NCHHSTP)/Division of HIV/AIDS Prevention (DHAP) is 
requesting approval for one year of a data collection entitled, 
``Understanding Barriers and Facilitators to HIV prevention for Men Who 
Have Sex with Men (MSM).'' The purpose of this study is to conduct 
primarily qualitative research with most at risk HIV-negative MSM. 
There are four goals to this study: (1) Understand issues surrounding 
HIV risk for MSM; (2) learn more about how gay community or peer norms, 
and community identification influence risk behaviors; (3) understand 
individual HIV risk management, such as having an HIV-positive partner 
with suppressed viral load, barriers and facilitators for use of 
biomedical interventions (i.e., pre-exposure prophylaxis (PrEP), non-
occupational post-exposure prophylaxis (nPEP); and (4) understand 
factors that promote resiliency among HIV-negative MSM.
    The present research will be conducted in the top five Southern 
metropolitan areas in the United States with the highest HIV diagnoses 
for MSM--Atlanta, Georgia; Jackson, Mississippi; Miami, Florida; and 
New Orleans and Baton Rouge, Louisiana. These cities rank among those 
in the South with the highest prevalence and incidence of HIV and 
sexually transmitted infections (STIs) among black/African American and 
Hispanic/Latino MSM.
    The study population will consist of black/African-American and 
Hispanic/Latino (1) male adolescents who are attracted to men and 
report they are HIV negative or have not been tested and (2) adult MSM 
who are recently tested and verified as HIV-negative.
    All study participants will be 13 years of age or older. 
Participants will be recruited in the selected cities through referrals 
from Health Departments, clinics and other HIV testing centers. In 
addition, we will recruit via word-of-mouth referrals or flyers given 
out by community-based, advocacy, faith-based, and service-providing 
agencies.
    Primarily, we will use a qualitative research design and will 
include a brief quantitative survey to reduce participant burden where 
possible (for example, when we do not need to know an in-depth answer 
for socio-demographics, HIV testing history, housing status, health 
insurance status). The first portion of the interview instrument 
consists of brief structured questions to characterize the respondents. 
The second portion of the instrument consists of open-ended in-depth 
qualitative questions. This research design was chosen based on the 
exploratory nature of our study purpose.
    All data collection tools will be pre-tested and interviews 
conducted by trained personnel. The data collection will take place at 
a time and place that is convenient to the respondent. Locations will 
be private. Data collection may be audio-recorded and transcribed with 
the consent of the respondent.
    We anticipate that consent forms and screener forms to take five 
minutes to complete each. We anticipate 50 percent of HIV-negative MSM 
screened will be eligible for the study. The brief structured survey 
(15 minutes) and in-depth interview (45 minutes) for HIV-negative MSM 
are expected to take a total of 60 minutes (1 hour) total. We will 
complete interviews for 105 black/African-American and 45 Hispanic/
Latino HIV-negative MSM at greatest risk for HIV in high prevalence 
cities in the U.S. South. We anticipate screening 300 potential 
respondents. The total number of burden hours are 192.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
General Public--Adults........  HIV-negative MSM             210               1            5/60              18
                                 Screener--Engli
                                 sh.
General Public--Adults........  HIV-negative MSM              90               1            5/60               8
                                 Screener--Spani
                                 sh.
General Public--Adults........  HIV-negative MSM             105               1            1/60               2
                                 Contact
                                 Information
                                 Form--English.
General Public--Adults........  HIV-negative MSM              45               1            1/60               1
                                 Contact
                                 Information
                                 Form--Spanish.
General Public--Adults........  HIV-negative MSM              95               1            5/60               8
                                 Consent Form--
                                 English.
General Public--Adults........  HIV-negative MSM              35               1            5/60               3
                                 Consent Form--
                                 Spanish.
General Public--Adults........  HIV-negative MSM              10               1            3/60               1
                                 Assent for
                                 Minors Form--
                                 English.
General Public--Adults........  HIV-negative MSM              10               1            3/60               1
                                 Assent for
                                 Minors Form--
                                 Spanish.

[[Page 27318]]

 
General Public--Adults........  HIV-negative MSM             105               1               1             105
                                 In-Depth
                                 Interview
                                 Guide--English.
General Public--Adults........  HIV-negative In-              45               1               1              45
                                 Depth Interview
                                 Guide--Spanish.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             192
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-11512 Filed 5-12-15; 8:45 am]
 BILLING CODE 4163-18-P

27316 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices

reportable conditions, which include coordinated at regional and national average burden per response based on
infectious and non-infectious diseases, levels. the burden tables from all of the
vary by jurisdiction depending upon CDC requests a three-year approval for consolidated applications has not
each jurisdiction’s health priorities and a revision the NNDSS information changed. The burden on the states and
needs. Infectious disease agents and collection. This Revision includes cities is estimated to be 10 hours per
environmental hazards often cross requests for approval to receive: (1) Case response and the burden on the
geographical boundaries. Each year, the notification data for Chikungunya, territories is estimated to be 5 hours per
Council of State and Territorial Disease Dengue-like illness, Non-HPS response. The addition of new vaccine,
Epidemiologists (CSTE), supported by Hantavirus, and Acute Flaccid Myelitis; laboratory, and disease-specific data
CDC, determines which reportable (2) new laboratory and vaccine data elements do not add any additional
conditions should be designated elements for all conditions; and (3) new burden because the states, territories,
nationally notifiable and voluntarily disease-specific data elements for and cities already collect those data
Mumps, Pertussis, and Sexually elements. There will be no increase in
submitted to CDC so that information
Transmitted Diseases. burden for the states, territories, and
can be shared across jurisdictional
Although this Revision includes case cities to send those data elements to
boundaries and both surveillance and notifications that were not part of the CDC. The estimated annual burden is
prevention and control activities can be last NNDSS Revision, the estimate of the 28,340 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Avg. burden
Number of Total burden
Type of respondents Form name responses per per response
respondents (in hrs.)
respondent (in hrs.)

States ................................................ Weekly and Annual .......................... 50 52 10 26,000
Territories .......................................... Weekly and Annual .......................... 5 52 5 1,300
Cities ................................................. Weekly and Annual .......................... 2 52 10 1,040

Total ........................................... ........................................................... ........................ ........................ ........................ 28,340

Leroy A. Richardson, collection request entitled, FOR FURTHER INFORMATION CONTACT: To
Chief, Information Collection Review Office, ‘‘Understanding Barriers and request more information on the
Office of Scientific Integrity, Office of the Facilitators to HIV prevention for Men proposed project or to obtain a copy of
Associate Director for Science, Office of the Who Have Sex with Men (MSM)’’ to the information collection plan and
Director, Centers for Disease Control and conduct qualitative research with most instruments, contact the Information
Prevention. at risk HIV-negative MSM. The research Collection Review Office, Centers for
[FR Doc. 2015–11514 Filed 5–12–15; 8:45 am] is intended to understand issues Disease Control and Prevention, 1600
BILLING CODE 4163–18–P surrounding HIV risk for MSM, identify Clifton Road NE., MS–D74, Atlanta,
influences of high risk behaviors and to Georgia 30329; phone: 404–639–7570;
investigate risk management and Email: omb@cdc.gov.
DEPARTMENT OF HEALTH AND resiliency among HIV-negative MSM.
HUMAN SERVICES SUPPLEMENTARY INFORMATION: Under the
DATES: Written comments must be Paperwork Reduction Act of 1995 (PRA)
Centers for Disease Control and received on or before July 13, 2015. (44 U.S.C. 3501–3520), Federal agencies
Prevention must obtain approval from the Office of
ADDRESSES: You may submit comments,
Management and Budget (OMB) for each
[60 Day–15–15AGK; Docket No. CDC–2015– identified by Docket No. CDC–2015–
collection of information they conduct
0032] 0032 by any of the following methods:
or sponsor. In addition, the PRA also
• Federal eRulemaking Portal: requires Federal agencies to provide a
Proposed Data Collection Submitted Regulation.gov. Follow the instructions 60-day notice in the Federal Register
for Public Comment and for submitting comments. concerning each proposed collection of
Recommendations • Mail: Leroy A. Richardson, information, including each new
AGENCY: Centers for Disease Control and Information Collection Review Office, proposed collection, each proposed
Prevention, CDC, Department of Health Centers for Disease Control and extension of existing collection of
and Human Services, HHS. Prevention, 1600 Clifton Road NE., MS– information, and each reinstatement of
D74, Atlanta, Georgia 30329. previously approved information
ACTION: Notice with comment period.
Instructions: All submissions received collection before submitting the
SUMMARY: The Centers for Disease must include the agency name and collection to OMB for approval. To
Control and Prevention (CDC), as part of Docket Number. All relevant comments comply with this requirement, we are
its continuing efforts to reduce public received will be posted without change publishing this notice of a proposed
burden and maximize the utility of to Regulations.gov, including any data collection as described below.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

government information, invites the personal information provided. For Comments are invited on: (a) Whether
general public and other Federal access to the docket to read background the proposed collection of information
agencies to take this opportunity to documents or comments received, go to is necessary for the proper performance
comment on proposed and/or Regulations.gov. of the functions of the agency, including
continuing information collections, as Please note: All public comment should be whether the information shall have
required by the Paperwork Reduction submitted through the Federal eRulemaking practical utility; (b) the accuracy of the
Act of 1995. This notice invites portal (Regulations.gov) or by U.S. mail to the agency’s estimate of the burden of the
comment on a new information address listed above. proposed collection of information; (c)

VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\13MYN1.SGM 13MYN1

27318 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of Total
Number of burden per
Type of respondent Form name responses per burden
respondents response
respondent hours
(in hours)

General Public—Adults ..................... HIV-negative MSM In-Depth Inter- 105 1 1 105
view Guide—English.
General Public—Adults ..................... HIV-negative In-Depth Interview 45 1 1 45
Guide—Spanish.

Total ........................................... ........................................................... ........................ ........................ ........................ 192

Leroy A. Richardson, Hampshire Ave., Document Control the sale and distribution of tobacco
Chief, Information Collection Review Office, Center, Bldg. 71, Rm. G335, Silver products issued under section 906(d) of
Office of Scientific Integrity, Office of the Spring, MD 20993–0002. Send one self- the FD&C Act, such as FDA’s
Associate Director for Science, Office of the addressed adhesive label to assist that ‘‘Regulations Restricting the Sale and
Director, Centers for Disease Control and office in processing your request or
Prevention.
Distribution of Cigarettes and Smokeless
include a fax number to which the draft Tobacco to Protect Children and
[FR Doc. 2015–11512 Filed 5–12–15; 8:45 am] guidance may be sent. See the Adolescents’’ (21 CFR part 1140). The
BILLING CODE 4163–18–P SUPPLEMENTARY INFORMATION section for term ‘‘no-tobacco-sale order’’ refers to
information on electronic access to the an order prohibiting the sale of tobacco
draft guidance. products at a retail outlet indefinitely or
DEPARTMENT OF HEALTH AND Submit electronic comments on the
HUMAN SERVICES for a specified period of time under
draft guidance to http:// section 303(f)(8) of the FD&C Act. A
Food and Drug Administration www.regulations.gov. Submit written
‘‘repeated violation’’ means ‘‘at least 5
comments to the Division of Dockets
[Docket No. FDA–2015–D–0404] violations of particular requirements
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm. over a 36-month period at a particular
Determination of the Period Covered 1061, Rockville, MD 20852. Identify retail outlet that constitute a repeated
by a No-Tobacco-Sale Order and comments with the docket number violation . . .’’ (section 103(q)(1)(A) of
Compliance With an Order; Draft found in brackets in the heading of this the Tobacco Control Act).
Guidance for Tobacco Retailers; document. FDA conducts inspections of retail
Availability outlets to evaluate compliance with the
FOR FURTHER INFORMATION CONTACT:
AGENCY: Food and Drug Administration, Colleen Maschal, Center for Tobacco requirements of the FD&C Act and
HHS. Products, Food and Drug implementing regulations. This draft
ACTION: Notice. Administration, Document Control guidance discusses the period of time to
Center, Bldg. 71, Rm. G335, 10903 New be covered by an NTSO where there is
SUMMARY: The Food and Drug Hampshire Ave., Silver Spring, MD evidence of ‘‘repeated violations’’ at a
Administration (FDA) is announcing the 20993, 1–877–287–1373, particular retail outlet. It also discusses
availability of a draft guidance for colleen.maschal@fda.hhs.gov. a retailer’s compliance with an NTSO.
tobacco retailers entitled SUPPLEMENTARY INFORMATION: This draft guidance is meant to
‘‘Determination of the Period Covered supplement FDA’s guidances entitled
by a No-Tobacco-Sale Order and I. Background
‘‘Civil Money Penalties and No-
Compliance With an Order.’’ The draft On June 22, 2009, President Obama Tobacco-Sale Orders for Tobacco
guidance, when finalized, will represent signed the Family Smoking Prevention Retailers’’ and ‘‘Civil Money Penalties
FDA’s current thinking with respect to and Tobacco Control Act (Tobacco for Tobacco Retailers and No-Tobacco-
imposing no-tobacco-sale orders Control Act) (Pub. L. 111–31) into law.
(NTSOs) on retailers who have Sale Orders: Responses to Frequently
The Tobacco Control Act amended the Asked Questions.’’
committed repeated violations of certain Federal Food, Drug, and Cosmetic Act
restrictions on the sale and distribution (the FD&C Act) to give FDA authority to II. Significance of Draft Guidance
of tobacco products. This draft guidance regulate the manufacture, marketing,
discusses, among other things, the and distribution of tobacco products to FDA is issuing this draft guidance
period of time covered by an NTSO and protect public health generally and to consistent with FDA’s good guidance
a retailer’s compliance with an NTSO. reduce tobacco use by minors. Section practices regulation (21 CFR 10.115).
DATES: Although you can comment on 906(d) of the FD&C Act (21 U.S.C. The draft guidance, when finalized, will
any guidance at any time (see 21 CFR 387f(d)) authorizes FDA to issue represent the Agency’s current thinking
10.115(g)(5)), to ensure that the Agency regulations that restrict the sale and with respect to the period of time to be
considers your comment on this draft distribution of tobacco products if FDA covered by NTSOs and retailers’
asabaliauskas on DSK5VPTVN1PROD with NOTICES

guidance before it begins work on the determines such regulations would be compliance with NTSOs. It does not
final version of the guidance, submit appropriate for the protection of the create or confer any rights for or on any
either electronic or written comments public health. Section 303(f)(8) of the person and does not operate to bind
on the draft guidance by June 29, 2015. FD&C Act (21 U.S.C. 333(f)(8)) FDA or the public. An alternative
ADDRESSES: Submit written requests for authorizes FDA to impose an NTSO approach may be used if such approach
single copies of this draft guidance to against a person found to have satisfies the requirements of the
the Center for Tobacco Products, Food committed repeated violations, at a applicable statutes and regulations.
and Drug Administration, 10903 New particular retail outlet, of restrictions on

VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\13MYN1.SGM 13MYN1

Document Created: 2015-12-16 07:47:09
Document Modified: 2015-12-16 07:47:09

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before July 13, 2015.
Contact		To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation		80 FR 27316

80 FR 27316 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 92 (May 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention