Advisory Committee; Allergenic Products Advisory Committee, Renewal, 34343-34344 [2016-12636]
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Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
DELTA FOCUS Awardees (SDVC executive directors,
SDVC project coordinators, SDVC empowerment evaluators, and SDVC-funded CCR project coordinators).
DELTA FOCUS Survey .........
59
1
1
Leroy A. Richardson,
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. 2016–12706 Filed 5–27–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–855(A, B, I)]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
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 a 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 June 30, 2016.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
sradovich on DSK3TPTVN1PROD with NOTICES
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20:07 May 27, 2016
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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, 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
Enrollment Application; Use: The
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primary function of the CMS–855
Medicare enrollment application is to
gather information from a provider or
supplier that tells us who it is, whether
it meets certain qualifications to be a
health care provider or supplier, where
it practices or renders its services, the
identity of the owners of the enrolling
entity, and other information necessary
to establish correct claims payments. No
comments were received during the 60day comment period (April 1, 2016 (81
FR 18855)). Form Number: CMS–855(A,
B, I) (OMB control number: 0938–0685);
Frequency: Annually; Affected Public:
Private Sector; Business or other forprofit and not-for-profit institutions;
Number of Respondents: 1,735,800;
Total Annual Responses: 86,480; Total
Annual Hours: 290,193. (For policy
questions regarding this collection
contact Kimberly McPhillips at 410–
786–5374.)
Dated: May 25, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–12694 Filed 5–27–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Allergenic
Products Advisory Committee,
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Allergenic Products
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Allergenic
Products Advisory Committee for an
additional 2 years beyond the charter
SUMMARY:
E:\FR\FM\31MYN1.SGM
31MYN1
sradovich on DSK3TPTVN1PROD with NOTICES
34344
Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
expiration date. The new charter will be
in effect until July 9, 2018.
DATES: Authority for the Allergenic
Products Advisory Committee will
expire on July 9, 2016, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Janie Kim, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6129, Silver Spring, MD 20993–0002;
301–796–9016, Janie.kim@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Allergenic Products Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety,
effectiveness, and adequacy of labeling
of marketed and investigational
allergenic biological products or
materials that are administered to
humans for the diagnosis, prevention, or
treatment of allergies and allergic
disease, and makes appropriate
recommendations to the Commissioner
of its findings regarding the affirmation
or revocation of biological product
licenses, on the safety, effectiveness,
and labeling of the products, on clinical
and laboratory studies of such products,
on amendments or revisions to
regulations governing the manufacture,
testing, and licensing of allergenic
biological products, and on the quality
and relevance of FDA’s research
programs which provide the scientific
support for regulating these agents.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of allergy,
immunology, pediatrics, internal
medicine, biochemistry, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
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Jkt 238001
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/
AllergenicProductsAdvisoryCommittee/
ucm129360.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–12636 Filed 5–27–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee;
Psychopharmacologic Drugs Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Psychopharmacologic
Drugs Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the
Psychopharmacologic Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
June 4, 2018.
DATES: Authority for the
Psychopharmacologic Drugs Advisory
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Committee will expire on June 4, 2016,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, PDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Psychopharmacologic Drugs Advisory
Committee. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The
Psychopharmacologic Drugs Advisory
Committee advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
the Food and Drug Administration has
regulatory responsibility. The
Committee reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the practice of
psychiatry and related fields and make
appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
psychopharmacology, psychiatry,
epidemiology or statistics, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
PsychopharmacologicDrugsAdvisory
Committee/ucm107528.htm or by
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34343-34344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12636]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Allergenic Products Advisory Committee,
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Allergenic Products Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the Allergenic
Products Advisory Committee for an additional 2 years beyond the
charter
[[Page 34344]]
expiration date. The new charter will be in effect until July 9, 2018.
DATES: Authority for the Allergenic Products Advisory Committee will
expire on July 9, 2016, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Janie Kim, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
6129, Silver Spring, MD 20993-0002; 301-796-9016,
Janie.kim@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Allergenic Products Advisory Committee (the Committee).
The Committee is a discretionary Federal advisory committee established
to provide advice to the Commissioner. The Committee advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective drugs for human use and, as
required, any other product for which FDA has regulatory
responsibility.
The Committee reviews and evaluates available data concerning the
safety, effectiveness, and adequacy of labeling of marketed and
investigational allergenic biological products or materials that are
administered to humans for the diagnosis, prevention, or treatment of
allergies and allergic disease, and makes appropriate recommendations
to the Commissioner of its findings regarding the affirmation or
revocation of biological product licenses, on the safety,
effectiveness, and labeling of the products, on clinical and laboratory
studies of such products, on amendments or revisions to regulations
governing the manufacture, testing, and licensing of allergenic
biological products, and on the quality and relevance of FDA's research
programs which provide the scientific support for regulating these
agents.
The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of allergy, immunology, pediatrics, internal medicine,
biochemistry, and related specialties. Members will be invited to serve
for overlapping terms of up to 4 years. Almost all non-Federal members
of this committee serve as Special Government Employees. The core of
voting members may include one technically qualified member, selected
by the Commissioner or designee, who is identified with consumer
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons. In addition to the
voting members, the Committee may include one non-voting member who is
identified with industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/ucm129360.htm or by contacting the
Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In
light of the fact that no change has been made to the committee name or
description of duties, no amendment will be made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-12636 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P
