83_FR_24581 83 FR 24478 - Proposed Data Collection Submitted for Public Comment and Recommendations

83 FR 24478 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 83, Issue 103 (May 29, 2018)

Page Range24478-24479
FR Document2018-11399

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National HIV Behavioral Surveillance among Transgender women (NHBS-Trans). CDC is requesting a new 2-year approval to pilot collecting standardized HIV-related behavioral data from transgender women at risk for HIV systematically selected from 9 Metropolitan Statistical Areas (MSAs) throughout the United States.

Federal Register, Volume 83 Issue 103 (Tuesday, May 29, 2018) 
[Federal Register Volume 83, Number 103 (Tuesday, May 29, 2018)]
[Notices]
[Pages 24478-24479]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-18AAE; Docket No. CDC-2018-0039]


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.

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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 the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled National HIV Behavioral 
Surveillance among Transgender women (NHBS-Trans). CDC is requesting a 
new 2-year approval to pilot collecting standardized HIV-related 
behavioral data from transgender women at risk for HIV systematically 
selected from 9 Metropolitan Statistical Areas (MSAs) throughout the 
United States.

DATES: CDC must receive written comments on or before July 30, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0039 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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 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

    National HIV Behavioral Surveillance System--among Transgender 
women (NHBS-Trans)--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 purpose of this data collection is to monitor behaviors related 
to Human Immunodeficiency Virus (HIV) transmission and prevention in 
the United States of transgender women, who are known to be at high 
risk for HIV infection, and to assess barriers to, and best strategies 
for, conducting bio-behavioral surveys among minority transgender women 
in nine cities. This includes recruiting, interviewing and providing 
HIV testing and referral to services (as needed) following CDC protocol 
based on an existing HIV Behavioral Surveillance system. The proposed 
respondents are 200 adult minority trangender women in each of nine 
cities (1,800 interviews total) who will each respond one time over the 
course of the two year pilot. The information will be collected over a 
two year period beginning no later than two months after OMB approval.
    NHBS-Trans provides information to help prevent HIV among 
transgender women. Preventing HIV, especially among high-risk groups, 
is an effective strategy for reducing individual, local, and national 
healthcare costs. The utility of this information is to provide CDC and 
local health department staff with data for evaluating progress towards 
local and national public health

[[Page 24479]]

goals, such as reducing new HIV infections, increasing the use of 
condoms, and targeting high risk groups by describing and monitoring 
the HIV risk behaviors, HIV seroprevalence and incidence, and HIV 
prevention experiences of persons at highest risk for HIV infection.
    The Centers for Disease Control and Prevention request two year 
approval for a new information collection. Data will be collected 
through anonymous, in-person interviews conducted with persons 
systematically selected from nine Metropolitan Statistical Areas (MSAs) 
throughout the United States; these nine MSAs were chosen based on 
having high HIV prevalence. A brief screening interview will be used to 
determine eligibility for participation in the behavioral assessment. 
Participants will be recruited through respondent-driven sampling, a 
scientifically proven recruitment strategy for reaching hidden, hard-
to-reach, or stigmatized populations. Interview data will be recorded 
on secure portable computers, without internet connections. Data will 
be transferred to secure, encrypted data servers. Data will be stored 
at CDC and shared with local health departments in accordance with 
existing data use agreements and the Assurance of Confidentiality for 
HIV/AIDS Surveillance Data. Data will be disseminated in aggregate 
through academic and agency publications, presentations, and reports. 
All data collection and activities will be anonymous.
    Personally identifiable information (PII) is not included in the 
data collection. The CDC Privacy Officer has assessed this package for 
applicability of 5 U.S.C. 552a. The Privacy Act is not applicable 
because PII is not being collected under this CDC funded activity. The 
NHBS-Trans formative interview and optional HIV testing are anonymous 
(neither names nor Social Security numbers are collected). Data that 
will be collected through NHBS-Trans, while sensitive, are not 
personally identifying.
    The data from the behavioral assessment will provide estimates of 
(1) behavior related to the risk of HIV and other sexually transmitted 
diseases, (2) prior testing for HIV, (3) and use of HIV prevention 
services. All persons interviewed will also be offered an HIV test, and 
will participate in a pre-test counseling session. No other federal 
agency systematically collects this type of information from persons at 
risk for HIV infection. These data have substantial impact on 
prevention program development and monitoring at the local, state, and 
national levels.
    The Burden Table below shows the estimated annualized burden hours 
for the participants' time. Annually, 990 participants will complete an 
eligibility screener (an average of 5 minutes to complete), 900 
participants will complete the Behavioral Assessment (an average of 40 
minutes to complete), and 900 will complete the Recruiter Debriefing 
Form (an average of two minutes to complete). The estimated total 
annualized burden would be 713 hours. Participation of respondents is 
voluntary. There are no costs to respondents other than their time.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Persons Screened...............................  Eligibility Screener...................             990               1            5/60              83
Eligible Participant...........................  Behavioral Assessment..................             900               1           40/60             600
Peer Recruiters................................  Recruiter Debriefing...................             900               1            2/60              30
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             713
--------------------------------------------------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting 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. 2018-11399 Filed 5-25-18; 8:45 am]
 BILLING CODE 4163-18-P

24478 Federal Register / Vol. 83, No. 103 / Tuesday, May 29, 2018 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents response (in hours) respondent (in hours) International panel physicians .......... TB Indicators Excel Spreadsheet .... 336 1 3 1,008 Total ........................................... ........................................................... ........................ ........................ ........................ 1,008 Jeffery M. Zirger, • Mail: Jeffrey M. Zirger, Information including the validity of the Acting Chief, Information Collection Review Collection Review Office, Centers for methodology and assumptions used; Office, Office of Scientific Integrity, Office Disease Control and Prevention, 1600 3. Enhance the quality, utility, and of the Associate Director for Science, Office Clifton Road NE, MS–D74, Atlanta, clarity of the information to be of the Director, Centers for Disease Control Georgia 30329. collected; and and Prevention. 4. Minimize the burden of the Instructions: All submissions received [FR Doc. 2018–11401 Filed 5–25–18; 8:45 am] must include the agency name and collection of information on those who BILLING CODE 4163–18–P Docket Number. CDC will post, without are to respond, including through the change, all relevant comments to use of appropriate automated, Regulations.gov. electronic, mechanical, or other DEPARTMENT OF HEALTH AND technological collection techniques or HUMAN SERVICES Please note: Submit all comments through other forms of information technology, the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the e.g., permitting electronic submissions Centers for Disease Control and of responses. Prevention address listed above. 5. Assess information collection costs. FOR FURTHER INFORMATION CONTACT: To Proposed Project [60Day–18–18AAE; Docket No. CDC–2018– 0039] request more information on the proposed project or to obtain a copy of National HIV Behavioral Surveillance the information collection plan and System—among Transgender women Proposed Data Collection Submitted instruments, contact Leroy A. (NHBS-Trans)—New—National Center for Public Comment and Richardson, Information Collection for HIV/AIDS, Viral Hepatitis, STD, and Recommendations Review Office, Centers for Disease TB Prevention (NCHHSTP), Centers for AGENCY: Centers for Disease Control and Control and Prevention, 1600 Clifton Disease Control and Prevention (CDC). Prevention (CDC), Department of Health Road NE, MS–D74, Atlanta, Georgia Background and Brief Description and Human Services (HHS). 30329; phone: 404–639–7570; Email: The purpose of this data collection is ACTION: Notice with comment period. omb@cdc.gov. to monitor behaviors related to Human SUPPLEMENTARY INFORMATION: Under the Immunodeficiency Virus (HIV) SUMMARY: The Centers for Disease Paperwork Reduction Act of 1995 (PRA) transmission and prevention in the Control and Prevention (CDC), as part of (44 U.S.C. 3501–3520), Federal agencies United States of transgender women, its continuing effort to reduce public must obtain approval from the Office of who are known to be at high risk for burden and maximize the utility of Management and Budget (OMB) for each HIV infection, and to assess barriers to, government information, invites the collection of information they conduct and best strategies for, conducting bio- general public and other Federal or sponsor. In addition, the PRA also behavioral surveys among minority agencies the opportunity to comment on requires Federal agencies to provide a transgender women in nine cities. This a proposed and/or continuing 60-day notice in the Federal Register includes recruiting, interviewing and information collection, as required by concerning each proposed collection of providing HIV testing and referral to the Paperwork Reduction Act of 1995. information, including each new services (as needed) following CDC This notice invites comment on a proposed collection, each proposed protocol based on an existing HIV proposed information collection project extension of existing collection of Behavioral Surveillance system. The titled National HIV Behavioral information, and each reinstatement of proposed respondents are 200 adult Surveillance among Transgender previously approved information minority trangender women in each of women (NHBS-Trans). CDC is collection before submitting the nine cities (1,800 interviews total) who requesting a new 2-year approval to collection to the OMB for approval. To will each respond one time over the pilot collecting standardized HIV- comply with this requirement, we are course of the two year pilot. The related behavioral data from transgender publishing this notice of a proposed information will be collected over a two women at risk for HIV systematically data collection as described below. year period beginning no later than two selected from 9 Metropolitan Statistical The OMB is particularly interested in months after OMB approval. Areas (MSAs) throughout the United comments that will help: NHBS-Trans provides information to States. 1. Evaluate whether the proposed help prevent HIV among transgender DATES: CDC must receive written collection of information is necessary women. Preventing HIV, especially daltland on DSKBBV9HB2PROD with NOTICES comments on or before July 30, 2018. for the proper performance of the among high-risk groups, is an effective ADDRESSES: You may submit comments, functions of the agency, including strategy for reducing individual, local, identified by Docket No. CDC–2018– whether the information will have and national healthcare costs. The 0039 by any of the following methods: practical utility; utility of this information is to provide • Federal eRulemaking Portal: 2. Evaluate the accuracy of the CDC and local health department staff Regulations.gov. Follow the instructions agency’s estimate of the burden of the with data for evaluating progress for submitting comments. proposed collection of information, towards local and national public health VerDate Sep<11>2014 16:39 May 25, 2018 Jkt 244001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\29MYN1.SGM 29MYN1

Federal Register / Vol. 83, No. 103 / Tuesday, May 29, 2018 / Notices 24479 goals, such as reducing new HIV be transferred to secure, encrypted data behavior related to the risk of HIV and infections, increasing the use of servers. Data will be stored at CDC and other sexually transmitted diseases, (2) condoms, and targeting high risk groups shared with local health departments in prior testing for HIV, (3) and use of HIV by describing and monitoring the HIV accordance with existing data use prevention services. All persons risk behaviors, HIV seroprevalence and agreements and the Assurance of interviewed will also be offered an HIV incidence, and HIV prevention Confidentiality for HIV/AIDS test, and will participate in a pre-test experiences of persons at highest risk Surveillance Data. Data will be counseling session. No other federal for HIV infection. disseminated in aggregate through agency systematically collects this type The Centers for Disease Control and academic and agency publications, of information from persons at risk for Prevention request two year approval presentations, and reports. All data HIV infection. These data have for a new information collection. Data collection and activities will be substantial impact on prevention will be collected through anonymous, anonymous. program development and monitoring at in-person interviews conducted with Personally identifiable information the local, state, and national levels. persons systematically selected from (PII) is not included in the data The Burden Table below shows the nine Metropolitan Statistical Areas collection. The CDC Privacy Officer has estimated annualized burden hours for (MSAs) throughout the United States; assessed this package for applicability of the participants’ time. Annually, 990 these nine MSAs were chosen based on 5 U.S.C. 552a. The Privacy Act is not participants will complete an eligibility having high HIV prevalence. A brief applicable because PII is not being screener (an average of 5 minutes to screening interview will be used to collected under this CDC funded complete), 900 participants will determine eligibility for participation in activity. The NHBS-Trans formative complete the Behavioral Assessment (an the behavioral assessment. Participants interview and optional HIV testing are average of 40 minutes to complete), and will be recruited through respondent- anonymous (neither names nor Social 900 will complete the Recruiter driven sampling, a scientifically proven Security numbers are collected). Data Debriefing Form (an average of two recruitment strategy for reaching that will be collected through NHBS- minutes to complete). The estimated hidden, hard-to-reach, or stigmatized Trans, while sensitive, are not total annualized burden would be 713 populations. Interview data will be personally identifying. hours. Participation of respondents is recorded on secure portable computers, The data from the behavioral voluntary. There are no costs to without internet connections. Data will assessment will provide estimates of (1) respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Total Number of burden per Type of respondents Form name responses per burden respondents response respondent (in hours) (in hours) Persons Screened ............................. Eligibility Screener ........................... 990 1 5/60 83 Eligible Participant ............................. Behavioral Assessment ................... 900 1 40/60 600 Peer Recruiters ................................. Recruiter Debriefing ......................... 900 1 2/60 30 Total ........................................... .......................................................... ........................ ........................ ........................ 713 Jeffrey M. Zirger, SUMMARY: The Food and Drug • Federal eRulemaking Portal: Acting Chief, Information Collection Review Administration (FDA or we) is https://www.regulations.gov. Follow the Office, Office of Scientific Integrity, Office announcing the availability of a final instructions for submitting comments. of the Associate Director for Science, Office guidance for industry entitled Comments submitted electronically, of the Director, Centers for Disease Control ‘‘Registration of Food Facilities: What including attachments, to https:// and Prevention. You Need To Know About the FDA www.regulations.gov will be posted to [FR Doc. 2018–11399 Filed 5–25–18; 8:45 am] Regulation—Small Entity Compliance the docket unchanged. Because your BILLING CODE 4163–18–P Guide.’’ The small entity compliance comment will be made public, you are guide (SECG) is intended to help small solely responsible for ensuring that your entities comply with a final rule we comment does not include any DEPARTMENT OF HEALTH AND issued in the Federal Register of July confidential information that you or a HUMAN SERVICES 14, 2016, entitled ‘‘Amendments to third party may not wish to be posted, Registration of Food Facilities.’’ The such as medical information, your or Food and Drug Administration final rule amends the registration of anyone else’s Social Security number, or food facilities regulations. confidential business information, such [Docket No. FDA–2018–D–1468] as a manufacturing process. Please note DATES: The announcement of the Registration of Food Facilities: What guidance is published in the Federal that if you include your name, contact You Need To Know About the Food Register on May 29, 2018. information, or other information that and Drug Administration Regulation; ADDRESSES: You may submit either identifies you in the body of your daltland on DSKBBV9HB2PROD with NOTICES Small Entity Compliance Guide; electronic or written comments on comments, that information will be Availability Agency guidances at any time as posted on https://www.regulations.gov. follows: • If you want to submit a comment AGENCY: Food and Drug Administration, with confidential information that you HHS. Electronic Submissions do not wish to be made available to the Submit electronic comments in the public, submit the comment as a ACTION: Notification of availability. following way: written/paper submission and in the VerDate Sep<11>2014 16:39 May 25, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\29MYN1.SGM 29MYN1


Document Created: 2018-05-26 00:48:08
Document Modified: 2018-05-26 00:48:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesCDC must receive written comments on or before July 30, 2018.
ContactTo 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 Citation83 FR 24478 
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