Agency Forms Undergoing Paperwork Reduction Act Review, 49849-49850 [2022-17358]
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49849
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–17360 Filed 8–11–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–0770]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘National HIV
Behavioral Surveillance System
(NHBS)’’ to the Office of Management
and Budget (OMB) for review and
approval. CDC previously published a
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on May 13,
2022 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
jspears on DSK121TN23PROD with NOTICES
(a) 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;
(b) Evaluate the accuracy of the agencies
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and assumptions
used;
(c) Enhance the quality, utility, and clarity
of the information to be collected;
(d) 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 submission of
responses; and
(e) Assess information collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
National HIV Behavioral Surveillance
System (NHBS) (OMB Control No.
0920–0770, Exp. 01/31/2023)—
Revision—National Center for HIV,
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 of persons at high
risk for infection that are related to
Human Immunodeficiency Virus (HIV)
transmission and prevention in the
United States. The primary objectives of
the NHBS are to obtain data from
samples of persons at risk to: (a)
describe the prevalence and trends in
risk behaviors; (b) describe the
prevalence of and trends in HIV testing
and HIV infection; (c) describe the
prevalence of and trends in use of HIV
prevention services; and (d) identify met
and unmet needs for HIV prevention
services in order to inform health
departments, community based
organizations, community planning
groups and other stakeholders.
By describing and monitoring the HIV
risk behaviors, HIV seroprevalence and
incidence, and HIV prevention
experiences of persons at highest risk
for HIV infection, NHBS provides an
important data source for evaluating
progress towards national public health
initiatives, such as reducing new
infections, increasing the use of
condoms, and targeting populations at
high risk.
The Centers for Disease Control and
Prevention requests approval for a threeyear Revision of this information
collection. Data are collected through
in-person interviews conducted with
persons systematically selected from 20
Metropolitan Statistical Areas (MSAs)
throughout the United States; these 20
MSAs are chosen based on highest
number of HIV infections diagnosed.
Persons at risk for HIV infection to be
interviewed for NHBS include men who
have sex with men (MSM), persons who
inject drugs (PWID), and heterosexually
active persons at increased risk of HIV
infection (HET). A brief screening
interview will be used to determine
eligibility for participation in the
behavioral assessment.
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; and (3) 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. CDC estimates that
NHBS will involve, per year, in up to 20
MSAs, eligibility screening for 125
persons and eligibility screening plus
the behavioral assessment with 500
eligible respondents, resulting in a total
of 30,000 eligible survey respondents
and 7,500 ineligible screened persons
during a three-year period. Data
collection will rotate such that
interviews will be conducted among one
group per year: MSM in Year 1, PWID
in Year 2, and HET in Year 3. The type
of data collected for each group will
vary slightly due to different sampling
methods and risk characteristics of the
group.
Participation of respondents is
voluntary and there is no cost to the
respondents other than their time. CDC
requests OMB approval for an estimated
6,600 annual burden hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Persons Screened ..........................................
Eligible Participants .........................................
Eligibility Screener ..........................................
Behavioral Assessment MSM ........................
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12,500
3,333
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Number of
responses per
respondent
1
1
Average
burden
per response
(in hours)
5/60
24/60
49850
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondents
Form name
Eligible Participants .........................................
Eligible Participant ..........................................
Peer Recruiters ...............................................
Behavioral Assessment PWID .......................
Behavioral Assessment HET .........................
Recruiter Debriefing .......................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–17358 Filed 8–11–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No. 0970–0577]
Proposed Information Collection
Activity; Evaluation of LifeSet
Correction
In notice document 2022–16791,
appearing on pages 48033 through
48034 in the issue of Friday, August 5,
2022, make the following corrections:
1. On page 48034, in the table, on the
third row, in the second cell, ‘‘LifeSet
Team
Supervisors’’ should appear below
‘‘LifeSet Specialists’’.
2. On the same page, in the same
table, remove the fourth row including
the text ‘‘LifeSet Team Supervisors’’.
[FR Doc. C1–2022–16791 Filed 8–11–22; 8:45 am]
Submit written comments
(including recommendations) on the
collection of information by September
12, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0823. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DATES:
Medical Device Accessories
BILLING CODE 0099–10–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1593]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Accessories
AGENCY:
Food and Drug Administration,
HHS.
jspears on DSK121TN23PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
VerDate Sep<11>2014
17:38 Aug 11, 2022
Jkt 256001
OMB Control Number 0910–0823—
Extension
FDA’s guidance document entitled
‘‘Medical Device Accessories—
Describing Accessories and
Classification Pathways’’ 1 is intended to
provide guidance to industry and FDA
staff about the regulation of accessories
to medical devices, to describe FDA’s
policy concerning the classification of
accessories, and to discuss the
application of this policy to devices that
are commonly used as accessories to
other medical devices. In addition, the
guidance explains what devices FDA
generally considers an ‘‘accessory’’ and
describes the processes under section
513(f)(6) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(f)(6)) to
1 The guidance document is available on FDA’s
website (https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/
medical-device-accessories-describing-accessoriesand-classification-pathways).
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
3,333
3,333
3,333
Number of
responses per
respondent
1
1
1
Average
burden
per response
(in hours)
43/60
31/60
2/60
allow requests for risk- and regulatory
control-based classification of
accessories.
The FDA Reauthorization Act of 2017
(FDARA) (Pub. L. 115–52) changed how
FDA regulates medical device
accessories. Specifically, section 707 of
FDARA added section 513(f)(6) to the
statute and requires that FDA, upon
request, classify existing and new
accessories notwithstanding the
classification of any other device with
which such accessory is intended to be
used. This means that the classification
of an accessory may not be the same as
its parent device, depending on the risks
of the accessory when used as intended
and the level of regulatory controls
necessary for reasonable assurance of
safety and effectiveness of the accessory.
Until an accessory is distinctly
classified, its existing classification will
continue to apply. This provision does
not preclude a manufacturer from
submitting a De Novo request for an
accessory.
Depending on an accessory’s
regulatory history, there are different
submission types, tracking mechanisms,
and deadlines:
(1) Existing accessory types are those
that have been identified in a
classification regulation or granted
marketing authorization as part of a
510(k), premarket approval application
(PMA), or De Novo request (approved
under OMB control numbers 0910–
0120, 0910–0231, and 0910–0844,
respectively). Manufacturers with
marketing authorization for an existing
accessory may request appropriate
classification through a new stand-alone
premarket submission (Existing
Accessory Request). Upon request, FDA
is required to meet with a manufacturer
or importer to discuss the appropriate
classification of an existing accessory
prior to submitting a written request.
Existing Accessory Requests will be
initially tracked as ‘‘Q-submissions’’
(approved under OMB control number
0910–0756). FDA has a statutory
deadline of 85 calendar days to respond
to an Existing Accessory Request.
(2) New accessory types are those that
have not been granted marketing
authorization as part of a 510(k), PMA,
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49849-49850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17358]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-0770]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``National HIV Behavioral Surveillance System
(NHBS)'' to the Office of Management and Budget (OMB) for review and
approval. CDC previously published a ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' notice on May 13,
2022 to obtain comments from the public and affected agencies. CDC did
not receive comments related to the previous notice. This notice serves
to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information
to be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
National HIV Behavioral Surveillance System (NHBS) (OMB Control No.
0920-0770, Exp. 01/31/2023)--Revision--National Center for HIV, 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 of
persons at high risk for infection that are related to Human
Immunodeficiency Virus (HIV) transmission and prevention in the United
States. The primary objectives of the NHBS are to obtain data from
samples of persons at risk to: (a) describe the prevalence and trends
in risk behaviors; (b) describe the prevalence of and trends in HIV
testing and HIV infection; (c) describe the prevalence of and trends in
use of HIV prevention services; and (d) identify met and unmet needs
for HIV prevention services in order to inform health departments,
community based organizations, community planning groups and other
stakeholders.
By describing and monitoring the HIV risk behaviors, HIV
seroprevalence and incidence, and HIV prevention experiences of persons
at highest risk for HIV infection, NHBS provides an important data
source for evaluating progress towards national public health
initiatives, such as reducing new infections, increasing the use of
condoms, and targeting populations at high risk.
The Centers for Disease Control and Prevention requests approval
for a three-year Revision of this information collection. Data are
collected through in-person interviews conducted with persons
systematically selected from 20 Metropolitan Statistical Areas (MSAs)
throughout the United States; these 20 MSAs are chosen based on highest
number of HIV infections diagnosed. Persons at risk for HIV infection
to be interviewed for NHBS include men who have sex with men (MSM),
persons who inject drugs (PWID), and heterosexually active persons at
increased risk of HIV infection (HET). A brief screening interview will
be used to determine eligibility for participation in the behavioral
assessment.
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; and (3) 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. CDC estimates that NHBS will involve, per year, in up to 20
MSAs, eligibility screening for 125 persons and eligibility screening
plus the behavioral assessment with 500 eligible respondents, resulting
in a total of 30,000 eligible survey respondents and 7,500 ineligible
screened persons during a three-year period. Data collection will
rotate such that interviews will be conducted among one group per year:
MSM in Year 1, PWID in Year 2, and HET in Year 3. The type of data
collected for each group will vary slightly due to different sampling
methods and risk characteristics of the group.
Participation of respondents is voluntary and there is no cost to
the respondents other than their time. CDC requests OMB approval for an
estimated 6,600 annual burden hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Persons Screened...................... Eligibility Screener.... 12,500 1 5/60
Eligible Participants................. Behavioral Assessment 3,333 1 24/60
MSM.
[[Page 49850]]
Eligible Participants................. Behavioral Assessment 3,333 1 43/60
PWID.
Eligible Participant.................. Behavioral Assessment 3,333 1 31/60
HET.
Peer Recruiters....................... Recruiter Debriefing.... 3,333 1 2/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-17358 Filed 8-11-22; 8:45 am]
BILLING CODE 4163-18-P
