National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 12489-12490 [2015-05306]
Download as PDF
Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number llll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
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/Paperwork
ReductionActof1995.
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:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
mstockstill on DSK4VPTVN1PROD with NOTICES
CMS–10555 Small Business Health
Options Program (SHOP) Effective Date
and Termination Notice Requirements
Under the 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
requires federal agencies to publish a
60-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.
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Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Small Business
Health Options Program (SHOP)
Effective Date and Termination Notice
Requirements; Use: We are requiring
that for plan years beginning on or after
January 1, 2017, the Small Business
Health Options Program (SHOP) must
ensure that a qualified health plan
(QHP) issuer notifies qualified
employees, enrollees, and new enrollees
in a QHP through the SHOP of the
effective date of coverage. As required
by the Patient Protection and Affordable
Care Act; HHS Notice of Benefit and
Payment Parameter for 2016 (CMS–
9944–F), which published February 27,
2015, if any enrollee’s coverage through
the SHOP is terminated due to nonpayment of premiums or a loss of the
enrollee’s or employer group’s eligibility
to participate in the SHOP, the SHOP
must notify the enrollee or the qualified
employer of the termination of such
coverage. In the termination of coverage
the SHOP must include the termination
date and reason for termination to the
enrollee or qualified employer. Form
Number: CMS–10555 (OMB Control
Number: 0938–New); Frequency:
Annually; Affected Public: Private
sector (Business or other for profits and
Not-for-profit institutions); Number of
Respondents: 445; Total Annual
Responses: 1,335; Total Annual Hours:
46,725. (For policy questions regarding
this collection contact Christelle Jang at
(410) 786–8438).
Dated: March 4, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–05420 Filed 3–6–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Organ
Transplantation (ACOT)
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice; correction.
AGENCY:
The Health Resources and
Services Administration published a
notice in the Federal Register, FR 2015–
03929 (February 26, 2015), announcing
the meeting for the Advisory Committee
SUMMARY:
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12489
on Organ Transplantation (ACOT). This
action is to add dial-in information.
Correction: In the Federal Register,
FR 2015–03929 (February 26, 2015),
please make the following addition:
Participants can also join this meeting via
conference call by calling the toll-free phone
number 888–324–4391 and providing the
participant pass code 7744447.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–05415 Filed 3–6–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Collaborative
Interdisciplinary Team Science in NIDDK
Research Areas (R24)–Hematopoiesis.
Date: March 20, 2015.
Time: 2:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Paul A. Rushing, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 747, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8895,
rushingp@extra.niddk.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK14–011
Chronic Kidney Disease Biomarkers
Consortium (CKD BioCon) (U01).
Date: March 24, 2015.
Time: 11:30 a.m. to 3:30 p.m.
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12490
Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Ann A. Jerkins, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 759, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, 301–594–2242,
jerkinsa@niddk.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; HIV-Associated
Nephropathy Program Project.
Date: March 30, 2015.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Michele L. Barnard, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 753, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 594–8898,
barnardm@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK R24 Review.
Date: March 30, 2015.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Robert Wellner, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 706, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, 301–594–4721,
rw175w@nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Building a Kidney:
Cells to Organ.
Date: April 7, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Marriott at Metro
Center, 775 12th St. NW., Washington, DC
20005.
Contact Person: Paul A. Rushing, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 747, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8895,
rushingp@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK R24 Grant
Review.
Date: April 8, 2015.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Robert Wellner, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 706, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, 301–594–4721
rw175w@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: March 3, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–05306 Filed 3–6–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0165]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Studies
To Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs
in Food-Producing Animals: Validation
of Analytical Methods Used in Residue
Depletion Studies; Revised Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised guidance for
industry (GFI #208) entitled ‘‘Studies to
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Animals: Validation of
Analytical Methods Used in Residue
Depletion Studies’’ (VICH GL49(R)).
This revised guidance, which provides
minor updates to a final guidance on the
same topic for which a notice of
availability was published in the
Federal Register of September 15, 2011,
has been developed for veterinary use
by the International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
This revised VICH guidance document
is intended to provide a general
description of the criteria that have been
found by the European Union, Japan,
United States, Australia, New Zealand,
SUMMARY:
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and Canada to be suitable for the
validation of analytical methods used in
veterinary drug residue depletion
studies.
Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
revised guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Julia
Oriani, Center for Veterinary Medicine
(HFV–151), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0788,
julia.oriani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote the
international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based
harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify, and then
reduce, differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
E:\FR\FM\09MRN1.SGM
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Agencies
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12489-12490]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05306]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; Collaborative
Interdisciplinary Team Science in NIDDK Research Areas (R24)-
Hematopoiesis.
Date: March 20, 2015.
Time: 2:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Paul A. Rushing, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 747, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301)
594-8895, rushingp@extra.niddk.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; RFA-DK14-011 Chronic
Kidney Disease Biomarkers Consortium (CKD BioCon) (U01).
Date: March 24, 2015.
Time: 11:30 a.m. to 3:30 p.m.
[[Page 12490]]
Agenda: To review and evaluate cooperative agreement
applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference
Call).
Contact Person: Ann A. Jerkins, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 759, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, 301-
594-2242, jerkinsa@niddk.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; HIV-Associated
Nephropathy Program Project.
Date: March 30, 2015.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Michele L. Barnard, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 753, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301)
594-8898, barnardm@extra.niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; NIDDK R24 Review.
Date: March 30, 2015.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Robert Wellner, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 706, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, 301-
594-4721, rw175w@nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; Building a Kidney: Cells
to Organ.
Date: April 7, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Washington Marriott at Metro Center, 775 12th St. NW.,
Washington, DC 20005.
Contact Person: Paul A. Rushing, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 747, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301)
594-8895, rushingp@extra.niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; NIDDK R24 Grant Review.
Date: April 8, 2015.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Robert Wellner, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 706, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, 301-
594-4721 rw175w@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
Dated: March 3, 2015.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-05306 Filed 3-6-15; 8:45 am]
BILLING CODE 4140-01-P