82 FR 46996 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 194 (October 10, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 194 (October 10, 2017)
| Page Range | 46996-46997 | |
| FR Document | 2017-21750 |
[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)] [Notices] [Pages 46996-46997] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21750] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-17-17AZI; Docket No. CDC-2017-0075] 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 effort 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 proposed study titled ``Understanding Decisions and Barriers about PrEP Use and Uptake among Men Who Have Sex with Men.'' This study will provide insight on individual and community level PrEP-related decision-making, and identify barriers and facilitators to successful PrEP initiation and PrEP acceptability. DATES: CDC must receive written comments on or before December 11, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC-2017- 0075 by any of the following methods:Federal eRulemaking Portal: Regulations.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. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all Federal comments 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 Leroy A. Richardson, 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 the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. 5. Assess information collection costs. Proposed Project Understanding Decisions and Barriers about PrEP Use and Uptake among Men Who Have Sex With 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 This project involves original, formative research toward improving the uptake and adherence necessary to achieve efficacious levels of protection offered by pre-exposure prophylaxis (PrEP) among the most affected population. HIV incidence and prevalence are higher among gay, bisexual, and other men who have sex with men (MSM) than any other risk group in the U.S. Approximately half of all diagnosed HIV infections are among gay, bisexual, and other MSM. The FDA-approved PrEP regimen, daily Tenofovir/emtricitabine (aka Truvada[supreg]), has shown greater than 90% efficacy in reducing HIV infections among MSM when taken in accordance with its prescribed daily schedule. In 2014, CDC published clinical practice guidelines for the use of PrEP in high-risk populations, and began national promotion of PrEP as an effective HIV prevention strategy for MSM. While hailed as an HIV-prevention ``game- changer,'' in reality PrEP uptake has been slow. Some studies report a wide range in the percentages of MSM (28-81%) interested in PrEP. In addition, other studies indicate that specific cities have alarmingly low rates of PrEP uptake (for example, the estimate for Atlanta is 2%). Moreover, recent survey findings have shown that less than 1 in 10 MSM on PrEP are adherent to their PrEP regimen; adherence is necessary to optimize efficacy. In order to develop effective programs that increase PrEP uptake among MSM at greatest risk for HIV, studies are needed to better understand the decisions men make about their HIV prevention needs. Qualitative methods will be used to explore in-depth the ``Whys'' and ``How's'' of MSM's decisions to refuse or use PrEP, and barriers and challenges to successfully undertake a PrEP medication regimen. Quantitative methods will be used to understand the HIV risk behavior context, attitudes towards PrEP, health seeking behavior, and acceptability of new modes of PrEP delivery (that differ from current recommendation of daily PrEP and that are in development or discussion) and emerging biomedical HIV prevention options. The purpose of this research is to explore decisions, barriers, and facilitators about PrEP use among MSM: (1) Who were offered PrEP but refused it; (2) who were interested in or started a PrEP regimen but did not follow through; and (3) who are eligible for PrEP per CDC guidelines (report condomless anal sex within last 3 months). [[Page 46997]] This study will provide insight on individual and community level PrEP-related decision-making, and identify barriers and facilitators to successful PrEP initiation and PrEP acceptability. Findings will improve programming, in line with the CDC Division of HIV/AIDS Prevention goal of high-impact prevention to reduce HIV infections in the Unite States. Findings will also assist the CDC and frontline public health programs in identifying and designing programs and intervention approaches that encourage, support, and maintain appropriate PrEP uptake among eligible MSM and anticipate future HIV prevention needs, including anticipated changes in PrEP delivery. The total annual burden hours are 335. There are no costs to the respondents other than their time, travel costs, and the total estimated annual burden hours. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondent Form name respondents responses per response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- General Public--Adults........ Screener #1..... 600 1 5/60 50 General Public--Adults........ Consent Forms... 300 1 1/60 5 General Public--Adults........ In-depth 60 1 45/60 45 Interview Guide. General Public--Adults........ Focus Group 60 1 1 60 Moderator Guide. General Public--Adults........ Eligibility 300 1 5/60 25 verification (verification of continuing eligibility). General Public--Adults........ Behavioral 300 1 30/60 150 Assessment. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 335 ---------------------------------------------------------------------------------------------------------------- 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. 2017-21750 Filed 10-6-17; 8:45 am] BILLING CODE 4163-18-P
![46996 Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Notices
Leroy A. Richardson, eRulemaking portal (regulations.gov) or Background and Brief Description
Chief, Information Collection Review Office, by U.S. mail to the address listed above. This project involves original,
Office of Scientific Integrity, Office of the FOR FURTHER INFORMATION CONTACT: To formative research toward improving
Associate Director for Science, Office of the request more information on the
Director, Centers for Disease Control and the uptake and adherence necessary to
Prevention.
proposed project or to obtain a copy of achieve efficacious levels of protection
the information collection plan and offered by pre-exposure prophylaxis
[FR Doc. 2017–21752 Filed 10–6–17; 8:45 am]
instruments, contact Leroy A. (PrEP) among the most affected
BILLING CODE 4163–18–P
Richardson, Information Collection population. HIV incidence and
Review Office, Centers for Disease prevalence are higher among gay,
Control and Prevention, 1600 Clifton bisexual, and other men who have sex
DEPARTMENT OF HEALTH AND
Road NE., MS–D74, Atlanta, Georgia with men (MSM) than any other risk
HUMAN SERVICES
30329; phone: 404–639–7570; Email: group in the U.S. Approximately half of
Centers for Disease Control and omb@cdc.gov. all diagnosed HIV infections are among
Prevention SUPPLEMENTARY INFORMATION: Under the gay, bisexual, and other MSM. The
Paperwork Reduction Act of 1995 (PRA) FDA-approved PrEP regimen, daily
[60Day-17–17AZI; Docket No. CDC–2017– (44 U.S.C. 3501–3520), Federal agencies Tenofovir/emtricitabine (aka Truvada®),
0075] must obtain approval from the Office of has shown greater than 90% efficacy in
Management and Budget (OMB) for each reducing HIV infections among MSM
Proposed Data Collection Submitted collection of information they conduct when taken in accordance with its
for Public Comment and or sponsor. In addition, the PRA also prescribed daily schedule. In 2014, CDC
Recommendations requires Federal agencies to provide a published clinical practice guidelines
AGENCY: Centers for Disease Control and 60-day notice in the Federal Register for the use of PrEP in high-risk
Prevention (CDC), Department of Health concerning each proposed collection of populations, and began national
and Human Services (HHS). information, including each new promotion of PrEP as an effective HIV
proposed collection, each proposed prevention strategy for MSM. While
ACTION: Notice with comment period.
extension of existing collection of hailed as an HIV-prevention ‘‘game-
SUMMARY: The Centers for Disease information, and each reinstatement of changer,’’ in reality PrEP uptake has
Control and Prevention (CDC), as part of previously approved information been slow. Some studies report a wide
its continuing effort to reduce public collection before submitting the range in the percentages of MSM (28–
burden and maximize the utility of collection to the OMB for approval. To 81%) interested in PrEP. In addition,
government information, invites the comply with this requirement, we are other studies indicate that specific cities
general public and other Federal publishing this notice of a proposed have alarmingly low rates of PrEP
agencies to take this opportunity to data collection as described below. uptake (for example, the estimate for
comment on proposed and/or The OMB is particularly interested in Atlanta is 2%). Moreover, recent survey
continuing information collections, as comments that will help: findings have shown that less than 1 in
required by the Paperwork Reduction 1. Evaluate whether the proposed 10 MSM on PrEP are adherent to their
Act of 1995. This notice invites collection of information is necessary PrEP regimen; adherence is necessary to
comment on a proposed study titled for the proper performance of the optimize efficacy.
‘‘Understanding Decisions and Barriers functions of the agency, including In order to develop effective programs
about PrEP Use and Uptake among Men whether the information will have that increase PrEP uptake among MSM
Who Have Sex with Men.’’ This study practical utility; at greatest risk for HIV, studies are
will provide insight on individual and 2. Evaluate the accuracy of the needed to better understand the
community level PrEP-related decision- agency’s estimate of the burden of the decisions men make about their HIV
making, and identify barriers and proposed collection of information, prevention needs. Qualitative methods
facilitators to successful PrEP initiation including the validity of the will be used to explore in-depth the
and PrEP acceptability. methodology and assumptions used; ‘‘Whys’’ and ‘‘How’s’’ of MSM’s
3. Enhance the quality, utility, and decisions to refuse or use PrEP, and
DATES: CDC must receive written
clarity of the information to be barriers and challenges to successfully
comments on or before December 11,
collected; and undertake a PrEP medication regimen.
2017.
4. Minimize the burden of the Quantitative methods will be used to
ADDRESSES: You may submit comments, collection of information on those who understand the HIV risk behavior
identified by Docket No. CDC–2017– are to respond, including through the context, attitudes towards PrEP, health
0075 by any of the following methods: use of appropriate automated, seeking behavior, and acceptability of
• Federal eRulemaking Portal: electronic, mechanical, or other new modes of PrEP delivery (that differ
Regulations.gov. Follow the instructions technological collection techniques or from current recommendation of daily
for submitting comments. other forms of information technology, PrEP and that are in development or
• Mail: Leroy A. Richardson, e.g., permitting electronic submissions discussion) and emerging biomedical
Information Collection Review Office, of responses. HIV prevention options.
Centers for Disease Control and 5. Assess information collection costs. The purpose of this research is to
Prevention, 1600 Clifton Road NE., MS– explore decisions, barriers, and
D74, Atlanta, Georgia 30329. Proposed Project facilitators about PrEP use among MSM:
sradovich on DSK3GMQ082PROD with NOTICES
Instructions: All submissions received Understanding Decisions and Barriers (1) Who were offered PrEP but refused
must include the agency name and about PrEP Use and Uptake among Men it; (2) who were interested in or started
Docket Number. CDC will post, without Who Have Sex With Men—New— a PrEP regimen but did not follow
change, all relevant comments to National Center for HIV/AIDS, Viral through; and (3) who are eligible for
Regulations.gov. Hepatitis, STD, and TB Prevention PrEP per CDC guidelines (report
Please note: Submit all Federal (NCHHSTP), Centers for Disease Control condomless anal sex within last 3
comments through the Federal and Prevention (CDC). months).
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![Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Notices 46997
This study will provide insight on prevention to reduce HIV infections in future HIV prevention needs, including
individual and community level PrEP- the Unite States. Findings will also anticipated changes in PrEP delivery.
related decision-making, and identify assist the CDC and frontline public The total annual burden hours are
barriers and facilitators to successful health programs in identifying and 335. There are no costs to the
PrEP initiation and PrEP acceptability. designing programs and intervention
respondents other than their time, travel
Findings will improve programming, in approaches that encourage, support, and
costs, and the total estimated annual
line with the CDC Division of HIV/AIDS maintain appropriate PrEP uptake
Prevention goal of high-impact among eligible MSM and anticipate burden hours.
ESTIMATED ANNUALIZED BURDEN HOURS
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 ..................... Screener #1 ...................................... 600 1 5/60 50
General Public—Adults ..................... Consent Forms ................................. 300 1 1/60 5
General Public—Adults ..................... In-depth Interview Guide .................. 60 1 45/60 45
General Public—Adults ..................... Focus Group Moderator Guide ........ 60 1 1 60
General Public—Adults ..................... Eligibility verification (verification of 300 1 5/60 25
continuing eligibility).
General Public—Adults ..................... Behavioral Assessment .................... 300 1 30/60 150
Total ........................................... ........................................................... ........................ ........................ ........................ 335
Leroy A. Richardson, Resource Access and Partnerships, is within the scope of the Indian health
Chief, Information Collection Review Office, Indian Health Service, 5600 Fishers program, as set forth in 42 CFR 136.12,
Office of Scientific Integrity, Office of the Lane, Mailstop: 10E85C, Rockville, creates no legal entitlement to PRC, only
Associate Director for Science, Office of the Maryland 20857. Telephone (301) 443– potential eligibility for services.
Director, Centers for Disease Control and 2694 (This is not a toll free number). Services needed but not available at an
Prevention. IHS or Tribal facility are provided under
SUPPLEMENTARY INFORMATION: The
[FR Doc. 2017–21750 Filed 10–6–17; 8:45 am] the PRC program depending on the
Passamaquoddy PRCDA previously
BILLING CODE 4163–18–P
covered Aroostook and Washington availability of funds, the person’s
Counties in the State of Maine. The relative medical priority, and the actual
expanded PRCDA for the Tribe’s availability and accessibility of alternate
DEPARTMENT OF HEALTH AND resources in accordance with the
reservation at Indian Township includes
HUMAN SERVICES regulations.
Hancock County in the State of Maine.
Indian Health Service This notice only relates to the expansion As applicable to the Tribes, these
of the Tribe’s PRCDA for the Indian regulations provide that, unless
Re-designation of the Delivery Area for Township reservation. otherwise designated, a PRCDA shall
the Passamaquoddy Tribe at Indian The Maine Indian Claims Settlement consist of a county that includes all or
Township Act of 1980 (Pub. L. 96–420; H. Rept. part of a reservation and any county or
96–1353) includes the intent of counties that have a common boundary
AGENCY: Indian Health Service, Congress to fund and provide with the reservation, 42 CFR
Department of Health and Human Purchased/Referred Care (PRC) to the 136.22(a)(6). The regulations also
Services. Passamaquoddy Tribe. The provide that after consultation with the
ACTION: Final Notice. Passamaquoddy Tribe has two Tribal governing body or bodies on
reservations: Indian Township and those reservations included within the
SUMMARY: This final notice advises the Pleasant Point. The PRCDA for the
public that the Indian Health Service PRCDA, the Secretary may from time to
Indian Township reservation is time, re-designate areas within the
(IHS) has decided to expand the Aroostook County, Maine, and
geographic boundaries of the United States for inclusion in or
Washington County, Maine. The PRCDA exclusion from a PRCDA. The
Purchased/Referred Care Delivery Area for the Pleasant Point reservation is
(PRCDA) for the Passamaquoddy Tribe’s regulations require that certain criteria
Washington County, Maine, south of must be considered before any re-
reservation at Indian Township State Route 9, and Aroostook County,
(Passamaquoddy at Indian Township or designation is made. The criteria are as
Maine. follows:
Tribe) in the State of Maine. Background: The IHS currently
DATES: October 10, 2017. (1) The number of Indians residing in
provides services under regulations
Inspection of Public Comments: The the area proposed to be so included or
codified at 42 CFR part 136, subparts A
IHS published a Federal Register Notice excluded;
through C. Subpart C defines a PRCDA,
entitled, ‘‘Notice To Propose the Re- formerly referred to as a Contract Health (2) Whether the Tribal governing body
sradovich on DSK3GMQ082PROD with NOTICES
Designation of the Service Delivery Area Service Delivery Area or Purchased/ has determined that Indians residing in
for the Passamaquoddy Tribe at Indian Referred Care Service Delivery Area, as the area near the reservation are socially
Township,’’ on March 8, 2017 (82 FR the geographic area within which PRC and economically affiliated with the
12968), and did not receive any will be made available by the IHS to Tribe;
comments regarding the notice. members of an identified Indian (3) The geographic proximity to the
FOR FURTHER INFORMATION CONTACT: community who reside in the area. reservation of the area whose inclusion
Terri Schmidt, Acting Director, Office of Residence in a PRCDA by a person who or exclusion is being considered; and
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Document Created: 2017-10-07 10:32:05
Document Modified: 2017-10-07 10:32:05
| 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 | CDC must receive written comments on or before December 11, 2017. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, 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 | 82 FR 46996 |
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