Submission for OMB Review; Comment Request, 20136-20137 [2019-09413]
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20136
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–09463 Filed 5–7–19; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2019–0039]
Vessel Sanitation Program: Annual
Program Status Meeting; Request for
Comment
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of public meeting and
request for comment.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces the
2019 annual Vessel Sanitation Program
(VSP) public meeting. The annual
meeting serves as a forum for HHS/CDC
to update cruise industry
representatives and other interested
persons on work completed in 2018 and
plans for future activities. HHS/CDC is
also opening a public docket so that
written comments and materials
regarding VSP’s 2018 and future work
may be submitted. The official record of
this meeting will remain open through
July 26, 2019, so that comments related
to the topics discussed at the meeting
may be submitted and made part of the
record.
DATES: Written comments must be
received on or before July 26, 2019.
The meeting will be held from 9:00
a.m. to 4:30 p.m. on June 27, 2019, in
the Ballroom at the DoubleTree Grand
Hotel Biscayne Bay, 1717 North
Bayshore Drive, Miami, FL 33132.
Information regarding logistics is
available on the VSP website
(www.cdc.gov/nceh/vsp).
Deadline for Requests for Special
Accommodations: Persons wishing to
participate in the public meeting who
need special accommodations should
contact Commander Aimee Treffiletti
(vsp@cdc.gov or 954–356–6650 or 770–
488–3141) by June 25, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0039, by any of the following methods:
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SUMMARY:
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• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Vessel Sanitation Program,
National Center for Environmental
Health, Centers for Disease Control and
Prevention, 4770 Buford Highway NE,
MS F–58, Atlanta, Georgia 30341.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to www.regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Commander Aimee Treffiletti, Vessel
Sanitation Program, National Center for
Environmental Health, Centers for
Disease Control and Prevention, 4770
Buford Highway NE, MS F–58, Atlanta,
Georgia 30341; phone: 954–356–6650 or
770–488–3141; email: vsp@cdc.gov.
The
purpose of the meeting is to inform the
public of VSP’s activities to help the
cruise industry prevent the introduction
and spread of gastrointestinal (GI)
illness to U.S. ports from ships under
VSP’s jurisdiction. Ships under VSP
jurisdiction have 13 or more passengers
and an itinerary that includes foreign
and U.S. ports.
The meeting will include a review of
HHS/CDC’s public health support
activities from 2018, provide
perspective on VSP’s approach to vessel
sanitation, and offer industry the
opportunity to provide input regarding
industry efforts to exceed VSP
requirements. Presentations will clarify
the roles and responsibilities of VSP,
cruise line public health management,
and shipyards constructing cruise ships.
Presentations will also include
initiatives for improved epidemiologic
study of disease outbreaks and strategic
approaches to public health risk
reduction for 2020 and the future.
SUPPLEMENTARY INFORMATION:
Matters To Be Discussed
• VSP year in review: Operational and
construction inspections, budget, and
vessel sanitation training
• GI illness data and epidemiology
projects: VSP review and progress
report
• VSP 2018 Operations Manual and
Construction Guidelines:
Implementation of the new guidance
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• Shipyard construction: How to
strengthen public health through
engineering controls
Meeting Accessibility: The meeting is
open to the public, but space is limited
to approximately 70 people. Advanced
registration is required. Information
regarding logistics is available on the
VSP website (www.cdc.gov/nceh/vsp).
Attendees at the annual meeting
normally include cruise ship industry
officials, private sanitation consultants,
and other interested parties.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2019–09393 Filed 5–7–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No.: 0970–0379]
Submission for OMB Review;
Comment Request
Title: ANA Project Outcome
Assessment Survey.
Description: The information
collected by the Project Outcome
Assessment Survey is needed for two
main reasons: 1) To collect crucial
information required to report on the
Administration for Native Americans’
(ANA) established Government
Performance and Results Act (GPRA)
measures, and 2) to properly abide by
ANA’s congressionally-mandated
statute (42 United States Code 2991 et
seq.) found within the Native American
Programs Act of 1974, as amended,
which states that ANA will evaluate
projects assisted through ANA grant
dollars ‘‘including evaluations that
describe and measure the impact of
such projects, their effectiveness in
achieving stated goals, their impact on
related programs, and their structure
and mechanisms for delivery of
services.’’ The information collected
with this survey will fulfill ANA’s
statutory requirement and will also
serve as an important planning and
performance tool for ANA.
Respondents: Tribal Governments,
Native American nonprofit
organizations, and Tribal Colleges and
Universities.
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20137
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ANA Project Outcome Assessment Survey ....................................................
85
1
6
510
Estimated Total Annual Burden
Hours: 510.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–09413 Filed 5–7–19; 8:45 am]
BILLING CODE 4184–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2973]
khammond on DSKBBV9HB2PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Obtaining
Information for Evaluating Nominated
Bulk Drug Substances for Use in
Compounding Drug Products 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) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 7,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Obtaining Information for
Evaluating Nominated Bulk Drug
Substances for Use in Compounding
Drug Products Under Section 503B of
the Federal Food, Drug, and Cosmetic
Act.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
Clinical Use of Bulk Drug Substances
Nominated for Use in Compounding by
Outsourcing Facilities OMB Control
Number 0910—NEW
This information collection supports
Agency-sponsored research. Section
503B of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
353b) requires FDA to develop a list of
bulk drug substances that may be used
in compounding under that section
(503B bulks list). Section 503B defines
compounding to include the combining,
admixing, mixing, diluting, pooling,
reconstituting, or otherwise altering of a
drug or bulk drug substance to create a
drug. Compounded drugs are not FDAapproved. If the conditions under
section 503B are met, drug products
compounded by entities known as
outsourcing facilities are exempt from
the following requirements of the FD&C
Act: requirements for FDA approval of
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drugs in section 505 of the FD&C Act
(21 U.S.C. 355), labeling with adequate
directions for use under section
502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)), and drug supply chain
security requirements under section 582
(21 U.S.C. 360eee-1). One of the
conditions that must be met for a drug
product compounded by an outsourcing
facility to qualify for these exemptions
is that the outsourcing facility may not
compound a drug using a bulk drug
substance unless (1) the bulk drug
substance appears on a list established
by the Secretary identifying bulk drug
substances for which there is a clinical
need (‘‘bulks list’’); or (2) the substance
appears on the drug shortage list in
effect under section 506E of the FD&C
Act (21 U.S.C. 356e) at the time of
compounding, distribution, and
dispensing.
Many bulk drug substances have been
nominated by the public for use in
compounding by outsourcing facilities
with adequate supporting information
for FDA to evaluate them. The
substances were nominated to treat a
variety of conditions. To inform our
evaluation of bulk drug substances for
inclusion on the 503B bulks list, we
have entered into a research study with
the University of Maryland (UMD)
Center of Excellence in Regulatory
Science and Innovation (CERSI) and the
Johns Hopkins University (JHU) CERSI.
FDA intends to use a two-part
analysis in evaluating substances
nominated for placement on the 503B
bulks list to determine whether there is
a clinical need. The collaboration with
CERSI–UMD and CERSI–JHU pertains to
part 2 of the analysis, which applies to
bulk drug substances that are not
components of FDA-approved drug
products, as well as certain bulk drug
substances that are components of FDAapproved drug products that have gone
through part 1 and warrant further
evaluation under part 2 of the analysis.
One of the factors that FDA considers
under part 2 is ‘‘current and historical
use of the substance in compounded
drug products, including information
about the medical condition(s) that the
substance has been used to treat and any
references in peer-reviewed medical
literature.’’
Researchers may use surveys,
interviews, focus groups, and other
E:\FR\FM\08MYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20136-20137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09413]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB No.: 0970-0379]
Submission for OMB Review; Comment Request
Title: ANA Project Outcome Assessment Survey.
Description: The information collected by the Project Outcome
Assessment Survey is needed for two main reasons: 1) To collect crucial
information required to report on the Administration for Native
Americans' (ANA) established Government Performance and Results Act
(GPRA) measures, and 2) to properly abide by ANA's congressionally-
mandated statute (42 United States Code 2991 et seq.) found within the
Native American Programs Act of 1974, as amended, which states that ANA
will evaluate projects assisted through ANA grant dollars ``including
evaluations that describe and measure the impact of such projects,
their effectiveness in achieving stated goals, their impact on related
programs, and their structure and mechanisms for delivery of
services.'' The information collected with this survey will fulfill
ANA's statutory requirement and will also serve as an important
planning and performance tool for ANA.
Respondents: Tribal Governments, Native American nonprofit
organizations, and Tribal Colleges and Universities.
[[Page 20137]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ANA Project Outcome Assessment Survey....... 85 1 6 510
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 510.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 330 C Street SW,
Washington, DC 20201. Attention Reports Clearance Officer. All requests
should be identified by the title of the information collection. Email
address: [email protected].
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Email:
[email protected], Attn: Desk Officer for the Administration
for Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-09413 Filed 5-7-19; 8:45 am]
BILLING CODE 4184-34-P
