Proposed Data Collection Submitted for Public Comment and Recommendations, 56836-56837 [2023-17925]
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56836
Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
Aim 1 participants—YMSM; General
public, adults.
Aim 2 participants—YMSM; General
public, adults.
Aim 2 participants—YMSM; General
public, adults.
Aim 2 participants—YMSM; General
public, adults.
Aim 3 participants—providers; General public, adults.
Aim 3 participants—providers; General public, adults.
Aim 3 participants—providers; General public, adults.
Aim 3 participant—clinic staff respondent, 1 per clinic site; General public, adults.
Total ...........................................
4
30/60
268
Aim 2 Participant Eligibility Screener
20
1
5/60
2
Aim 2 Participant Locator Form .......
10
1
5/60
1
Aim 2 Participant Interview Guide ...
10
1
1.0
10
Aim 3 Participant Eligibility Screener
14
1
5/60
2
Aim 3 Participant Locator Form .......
7
1
5/60
1
Aim 3 Participant Interview Guide ...
7
1
1.0
7
Aim 3 Clinic Assessment .................
4
2
30/60
4
...........................................................
........................
........................
........................
441
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–1319; Docket No. CDC–2023–
0073]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled National
Surveillance of Community Water
Systems and Corresponding Populations
with the Recommended Fluoridation
Level. This surveillance collects the
fluoridation status of, and population
served by the nation’s 52,000
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Total burden
(in hr)
134
[FR Doc. 2023–17921 Filed 8–18–23; 8:45 am]
18:17 Aug 18, 2023
Average
burden per
response
(in hr)
Aim 1 Participant Follow-up Survey
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
VerDate Sep<11>2014
Number of
responses per
respondent
Number of
respondents
Form name
Jkt 259001
community water systems (CWS) which
serve the 50 States and the District of
Columbia.
DATES: CDC must receive written
comments on or before October 20,
2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2023–
0073 by either of the following methods:
• Federal eRulemaking Portal:
www.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 H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.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 Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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;
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; and
5. Assess information collection costs.
E:\FR\FM\21AUN1.SGM
21AUN1
56837
Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices
Proposed Project
National Surveillance of Community
Water Systems and Corresponding
Populations with the Recommended
Fluoridation Level (OMB Control No.
0920–1319, Exp. 2/29/2024)—
Extension—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Community water fluoridation is the
process of adjusting the fluoride
concentration of a community water
system (CWS) to the level beneficial for
prevention of dental caries as
recommended by the U.S. Public Health
Service (PHS). Community water
fluoridation is a major factor
programs. CDC uses the Water
Fluoridation Reporting System (WFRS)
to collect water fluoridation coverage
and quality throughout the U.S. This
data allows CDC and States to monitor
the performance and efficiency of their
water fluoridation programs, which will
improve and extend program delivery.
Respondents to the information
collection are State fluoridation
managers or other State government
officials designated by the State dental
director or drinking water administrator.
State participation in the data collection
is voluntary.
CDC requests OMB approval for an
estimated 2,824 annual burden hours.
There is no cost to respondents other
than their time to participate.
contributing to the large decline in
caries in the U.S. in the past 75 years
and is recognized as one of 10 great
public health achievements of the
twentieth century. Community water
fluoridation reduces dental caries by
25% and is a safe and the cost-effective
way to deliver fluoride to people of all
ages, regardless of education and
income level. It is especially important
for populations with limited access to
preventive dental measures.
CDC is authorized to collect the
information under the U.S. Public
Health Service Act. This data collection
aligns with CDC’s strategy to use public
health surveillance to inform programs
and policies to improve the oral health
of the nation by reducing disparities and
expanding access to effective prevention
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
State Official ......................................
State Official ......................................
Fluoridation status and population ...
Fluoride testing data ........................
50
33
1
1
38
28
1,900
924
Total ...........................................
...........................................................
........................
........................
........................
2,824
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–17925 Filed 8–18–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3240]
List of Bulk Drug Substances for
Which There is a Clinical Need Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is evaluating substances that have
been nominated for inclusion on a list
of bulk drug substances (active
pharmaceutical ingredients) for which
there is a clinical need (the 503B Bulks
List). Drug products that outsourcing
facilities compound using bulk drug
substances on the 503B Bulks List can
qualify for certain exemptions from the
Federal Food, Drug, and Cosmetic Act
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Type of respondents
VerDate Sep<11>2014
18:17 Aug 18, 2023
Jkt 259001
(FD&C Act) provided certain conditions
are met. This notice identifies two bulk
drug substances that FDA has
considered and is not including on the
list at this time: ephedrine sulfate and
hydroxychloroquine sulfate. Additional
bulk drug substances nominated by the
public for inclusion on this list are
currently under consideration and will
be the subject of future notices.
DATES: The announcement of the notice
is published in the Federal Register on
August 21, 2023.
ADDRESSES: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts,
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Tracy Rupp, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Silver Spring, MD 20993,
301–796–3100.
SUPPLEMENTARY INFORMATION:
I. Background
Section 503B of the FD&C Act (21
U.S.C. 353b) describes the conditions
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
that must be satisfied for drug products
compounded in an outsourcing facility
to be exempt from section 505 (21
U.S.C. 355) (concerning the approval of
drugs under new drug applications
(NDAs) or abbreviated new drug
applications (ANDAs)), section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate
directions for use), and section 582 of
the FD&C Act (21 U.S.C. 360eee–1)
(concerning drug supply chain security
requirements).1
Compounded drug products that meet
the conditions set forth in section 503B
are not exempt from current good
manufacturing practice (CGMP)
requirements in section 501(a)(2)(B) of
the FD&C Act (21 U.S.C. 351(a)(2)(B)).2
Outsourcing facilities are also subject to
FDA inspections according to a riskbased schedule, adverse event reporting
requirements, and other conditions that
help to mitigate the risks of the drug
products they compound.3 Outsourcing
facilities may or may not obtain
prescriptions for identified individual
patients and can, therefore, distribute
compounded drugs to healthcare
1 Section
503B(a) of the FD&C Act.
section 503A(a) of the FD&C Act (21
U.S.C. 353a(a) (exempting drugs compounded in
accordance with that section)) with section 503B(a)
of the FD&C Act (not providing an exemption from
CGMP requirements).
3 Section 503B(b)(4) and (5) of the FD&C Act.
2 Compare
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Notices]
[Pages 56836-56837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17925]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-1319; Docket No. CDC-2023-0073]
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 the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled National Surveillance of Community Water Systems and
Corresponding Populations with the Recommended Fluoridation Level. This
surveillance collects the fluoridation status of, and population served
by the nation's 52,000 community water systems (CWS) which serve the 50
States and the District of Columbia.
DATES: CDC must receive written comments on or before October 20, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0073 by either of the following methods:
Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.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 Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 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;
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; and
5. Assess information collection costs.
[[Page 56837]]
Proposed Project
National Surveillance of Community Water Systems and Corresponding
Populations with the Recommended Fluoridation Level (OMB Control No.
0920-1319, Exp. 2/29/2024)--Extension--National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Community water fluoridation is the process of adjusting the
fluoride concentration of a community water system (CWS) to the level
beneficial for prevention of dental caries as recommended by the U.S.
Public Health Service (PHS). Community water fluoridation is a major
factor contributing to the large decline in caries in the U.S. in the
past 75 years and is recognized as one of 10 great public health
achievements of the twentieth century. Community water fluoridation
reduces dental caries by 25% and is a safe and the cost-effective way
to deliver fluoride to people of all ages, regardless of education and
income level. It is especially important for populations with limited
access to preventive dental measures.
CDC is authorized to collect the information under the U.S. Public
Health Service Act. This data collection aligns with CDC's strategy to
use public health surveillance to inform programs and policies to
improve the oral health of the nation by reducing disparities and
expanding access to effective prevention programs. CDC uses the Water
Fluoridation Reporting System (WFRS) to collect water fluoridation
coverage and quality throughout the U.S. This data allows CDC and
States to monitor the performance and efficiency of their water
fluoridation programs, which will improve and extend program delivery.
Respondents to the information collection are State fluoridation
managers or other State government officials designated by the State
dental director or drinking water administrator. State participation in
the data collection is voluntary.
CDC requests OMB approval for an estimated 2,824 annual burden
hours. There is no cost to respondents other than their time to
participate.
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)
----------------------------------------------------------------------------------------------------------------
State Official................ Fluoridation 50 1 38 1,900
status and
population.
State Official................ Fluoride testing 33 1 28 924
data.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 2,824
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2023-17925 Filed 8-18-23; 8:45 am]
BILLING CODE 4163-18-P
