Agency Information Collection Activities: Submission for OMB Review; Comment Request, 80665-80666 [2016-27455]
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Federal Register / Vol. 81, No. 221 / Wednesday, November 16, 2016 / Notices
following topics: Biosafety and
biosecurity regulations; radiation threat
preparedness and response; medical
countermeasures; and risk
communications.
CONTACT PERSON FOR MORE INFORMATION:
Dometa Ouisley, Office of Science and
Public Health Practice, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., Mailstop D–44,
Atlanta, Georgia 30329–4027,
Telephone: (404) 639–7450; Facsimile:
(404)639–7977; Email:
OPHPR.BSC.Questions@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both the
Centers for Disease Control and
Prevention, and Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Service
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2016–27493 Filed 11–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Council for the Elimination of
Tuberculosis Meeting (ACET)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
Times and Dates: 8:30 a.m.–5:00 p.m.,
EST, December 12, 2016; 8:30 a.m.–
12:00 p.m., EST, December 13, 2016.
Place: Corporate Square, Building 8,
1st Floor Conference Room, Atlanta,
Georgia 30329, telephone (404) 639–
8317.
This meeting is also accessible by
Webinar:
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December 12, 2016
For Participants:
URL: https://www.mymeetings.com/nc/
join/
Conference number: PW1642870
Audience passcode: 4727233
Participants can join the event directly
at: https://www.mymeetings.com/nc/
join.php?i=PW1642870&
p=4727233&t=c
USA Toll-free +1 (877) 951–7311,
Participant code: 4727233
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Prevention and the Agency for Toxic
Substances and Disease Registry.
December 13, 2016
For Participants:
URL: https://www.mymeetings.com/nc/
join/
Conference number: PW1642897
Audience passcode: 4727233
Participants can join the event directly
at: https://www.mymeetings.com/nc/
join.php?i=PW1642897&
p=4727233&t=c
USA Toll-free +1 (877) 951–7311,
Participant code: 4727233
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 100
people. Persons who desire to make an
oral statement, may request it at the
time of the public comment period on
December 13, 2016 at 11:40 a.m., (EDT).
Public participation and ability to
comment will be limited to space and
time as it permits.
Purpose: This Council advises and
makes recommendations to the
Secretary of Health and Human
Services, the Assistant Secretary for
Health, and the Director, CDC, regarding
the elimination of tuberculosis.
Specifically, the Council makes
recommendations regarding policies,
strategies, objectives, and priorities;
addresses the development and
application of new technologies; and
reviews the extent to which progress has
been made toward eliminating
tuberculosis.
Matters for Discussion: Agenda items
include the following topics: (1)
Recently Published Data on TB in Jails
and Prisons in the United States; (2)
Expanded Latent TB Infection (LTBI)
Testing and Treatment Plans
(Massachusetts Demonstration Project);
(3) Update on the National Center for
HIV/AIDS, Viral Hepatitis, STD and TB
Prevention Economic Modeling
Agreement (NEEMA) TB Projects; (4)
Updates from Workgroups; and (5) other
tuberculosis-related issues. Agenda
items are subject to change as priorities
dictate.
Contact Person for More Information:
Margie Scott-Cseh, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE., M/S E–07, Atlanta, Georgia
30333, telephone (404) 639–8317.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
Notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
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Elaine L. Baker,
Director, Management Analysis and Services
Office,Centers for Disease Control and
Prevention.
[FR Doc. 2016–27492 Filed 11–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers CMS–10287]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by December 16, 2016.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions:
OMB, Office of Information and
Regulatory Affairs
Attention: CMS Desk Officer
SUMMARY:
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80666
Federal Register / Vol. 81, No. 221 / Wednesday, November 16, 2016 / Notices
Fax Number: (202) 395–5806 OR
Email: OIRA_submission@
omb.eop.gov
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
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. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Quality of Care Complaint Form; Use: In
accordance with Section 1154(a)(14) of
the Social Security Act, Quality
Improvement Organizations (QIOs) are
required to conduct appropriate reviews
of all written complaints submitted by
beneficiaries concerning the quality of
care received. The Medicare Quality of
Care Complaint Form will be used by
Medicare beneficiaries to submit quality
of care complaints. This form will
establish a standard form for all
beneficiaries to utilize and ensure
pertinent information is obtained by
QIOs to effectively process these
complaints. Form Number: CMS–10287
(OMB control number: 0938–1102);
Frequency: Occasionally; Affected
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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Public: Individuals and Households;
Number of Respondents: 3,500; Total
Annual Responses: 3,500; Total Annual
Hours: 583. (For policy questions
regarding this collection contact
Winsome Higgins at 410–786–1835.)
Dated: November 9, 2016
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–27455 Filed 11–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3744]
Site Visit Training Program for Office
of Pharmaceutical Quality Staff;
Information Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Center for Drug
Evaluation and Research (CDER) in the
Food and Drug Administration (FDA) is
announcing the 2017 CDER Office of
Pharmaceutical Quality (OPQ) Staff
Experiential Learning Site Visit
Program. The purpose of this document
is to invite pharmaceutical companies
interested in participating in this
program to submit a site visit proposal
to CDER’s OPQ.
DATES: Submit either an electronic or
written proposal to participate in this
program by January 17, 2017. See
section IV of this document for
information on what to include in such
proposals.
FOR FURTHER INFORMATION CONTACT:
Janet Wilson, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 4642, Silver Spring,
MD 20993–0002, 240–402–3969, email:
CDEROPQSiteVisits@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
A critical part of the commitment by
CDER to make safe and effective highquality drugs available to the American
public is gaining an understanding of all
aspects of drug development and a
drug’s commercial life cycle, including
the variety of drug manufacturing
operations. To support this
commitment, CDER has initiated
various training and development
programs, including the 2017 OPQ Staff
Experiential Learning Site Visit
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Program. This site visit program is
designed to offer experiential and
firsthand learning opportunities that
will provide OPQ staff with a better
understanding of the pharmaceutical
industry and its operations, as well as
of the challenges that impact a drug’s
development program and commercial
life cycle. The goal of these visits is to
provide OPQ staff exposure to the drug
development and manufacturing
processes in industry; therefore, a tour
of pharmaceutical company facilities is
an integral part of the program.
II. The Site Visit Program
In this site visit program, groups of
OPQ staff—who have experience in a
variety of backgrounds, including
science, statistics, manufacturing,
engineering and testing—will observe
operations of commercial
manufacturing, pilot plants, and testing
over a 1- to 2-day period. To facilitate
the learning process for OPQ staff,
overview presentations by industry
related to drug development and
manufacturing may be provided, which
may allow the participating sites to
benefit by having an opportunity to
showcase their technologies and
manufacturing processes.
OPQ encourages companies engaging
in the development and manufacturing
of both drug substances and drug
products to respond. However, please
note that this site visit program is not
intended to supplement or to replace a
regulatory inspection, e.g., a
preapproval inspection, pre-license
inspection or a surveillance inspection.
OPQ staff participating in this program
will grow professionally by gaining a
better understanding of current industry
practices, processes, and procedures.
Although observation of all aspects of
drug development and production
would be beneficial to OPQ staff, OPQ
has identified a number of areas of
particular interest to its staff. The
following list identifies some of these
areas but is not intended to be
exhaustive or to limit industry response:
• Drug products and active
pharmaceutical ingredients
Æ Solutions, suspensions, emulsions,
and semisolids
Æ Sustained, modified, and immediate
release formulations
Æ Drug-device combination products,
particularly inhalation, transdermal,
iontophoretic, and implant
formulations
Æ Biotechnology products
• Design, development, manufacturing,
and controls
Æ Engineering controls for aseptic
formulations
Æ Unique delivery technologies
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Agencies
[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Notices]
[Pages 80665-80666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27455]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers CMS-10287]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by December 16, 2016.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions:
OMB, Office of Information and Regulatory Affairs
Attention: CMS Desk Officer
[[Page 80666]]
Fax Number: (202) 395-5806 OR
Email: OIRA_submission@omb.eop.gov
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
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. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare Quality
of Care Complaint Form; Use: In accordance with Section 1154(a)(14) of
the Social Security Act, Quality Improvement Organizations (QIOs) are
required to conduct appropriate reviews of all written complaints
submitted by beneficiaries concerning the quality of care received. The
Medicare Quality of Care Complaint Form will be used by Medicare
beneficiaries to submit quality of care complaints. This form will
establish a standard form for all beneficiaries to utilize and ensure
pertinent information is obtained by QIOs to effectively process these
complaints. Form Number: CMS-10287 (OMB control number: 0938-1102);
Frequency: Occasionally; Affected Public: Individuals and Households;
Number of Respondents: 3,500; Total Annual Responses: 3,500; Total
Annual Hours: 583. (For policy questions regarding this collection
contact Winsome Higgins at 410-786-1835.)
Dated: November 9, 2016
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2016-27455 Filed 11-15-16; 8:45 am]
BILLING CODE 4120-01-P