National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting, 14390-14391 [2015-06270]
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Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices
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:
Ruth Barratt, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, Rm. 4540, Silver Spring,
MD 20993–0002, 301–796–2600.
SUPPLEMENTARY INFORMATION:
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I. Background
Since publication of the 2011
‘‘Identifying CDER’s Science and
Research Needs’’ report, FDA has been
engaged in efforts to further assess and
prioritize the needs articulated therein.
As part of these efforts, CDER’s Safety
Research Interest Group (SRIG), a
subcommittee of the Science
Prioritization and Review Committee,
assessed CDER’s overall drug safetyrelated regulatory science needs in view
of FDA’s ongoing research efforts and
highlighted areas that would benefit
from additional resources and
collaboration.
The SRIG identified the following
seven overall needs for drug safetyrelated regulatory science:
1. Improve access to postmarket data
sources and explore the feasibility of
their use in safety signal analyses
2. Improve risk assessment and
management strategies to reinforce the
safe use of drugs
3. Evaluate the effectiveness of risk
communications of drug safety
information to health care providers and
the public
4. Improve product quality and
design, manufacturing processes, and
product performance relating to safety
5. Develop and improve predictive
models of safety in humans, including
nonclinical biomarkers
6. Improve clinical trial statistical
analyses for safety, including benefitrisk assessment
7. Investigate clinical biomarkers of
safety, including standards for
qualification.
Particular priorities within the seven
overall needs requiring further resources
and outside participation were also
identified. FDA seeks to stimulate
collaborations with external partners
and stakeholders to address these needs
by asking them to: (1) Submit
descriptions of their ongoing research
and initiatives related to the seven
overall needs, especially the identified
priorities, and (2) indicate their interest
in working with FDA to address these
needs. Outside parties are being asked
to submit comments to the docket and
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email address CDER_Science_Needs@
fda.hhs.gov.
II. Comments
Interested persons may submit either
electronic comments regarding the
report to https://www.regulations.gov
and email address CDER_Science_
Needs@fda.hhs.gov, or written
comments to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the report at https://
www.regulations.gov.
Dated: March 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06288 Filed 3–18–15; 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; NIDDK Ancillary
R01 Telephone Review SEP.
Date: April 3, 2015
Time: 2:30 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).
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Contact Person: Xiaodu Guo, MD, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes Of Health,
Room 761, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–4719,
guox@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; Collaborative
Interdisciplinary Team Science in Diabetes
and Obesity (R24).
Date: April 6, 2015.
Time: 2:30 p.m. to 4:30 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: 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.
(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 13, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–06266 Filed 3–18–15; 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;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Diabetes and Digestive and Kidney
Diseases Special Emphasis Panel, March
31, 2015, 04:00 p.m. to April 01, 2015,
05:00 p.m., Churchill Hotel, 1914
Connecticut Avenue NW., Washington,
DC, 20009 which was published in the
Federal Register on March 09, 2015, 80
FR 12494.
The meeting is being amended to
reflect location change. The new
meeting location is the Hyatt Regency
Bethesda, One Bethesda Metro Center,
Bethesda, MD 20814. The meeting is
closed to the public.
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Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices
Dated: March 13, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–06270 Filed 3–18–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
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Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Advisory Committee on Research on
Women’s Health.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Advisory Committee
on Research on Women’s Health.
Date: April 10, 2014.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: The Committee serves to advise
and make recommendations to the Director,
Office of Research on Women’s Health
(ORWH) on a broad range of topics including,
the current scope of research on women’s
health and the influence of sex and gender
on human health, efforts to understand the
issues related to women in biomedical
careers and their needs, and the current
status of inclusion of women in clinical trials
research.
Place: National Institutes of Health,
Building 35, Room 620/630, 35 Convent
Drive, Bethesda, MD 20892.
Contact Person: Susan E Maier, Ph.D., NIH/
OD, 6707 Democracy Blvd., Room 400,
Bethesda, MD 20852, 301–435–1573,
maiers@mail.nih.gov.
Any interested person may file written
comments for the public record by
submitting their comments to the following
email address ACRWHComments@
sp10mail.nih.gov. Written comments for the
public record must not exceed two singlespaced, typed pages, using a 12-point
typeface and 1 inch margins; it is preferred
that the document be prepared in the MS
Word® format. Only testimony submitted to
this Web site and received in advance of the
meeting are part of the official meeting
record.
Supplementary Information: A draft
agenda for this meeting is posted at
https://orwh.od.nih.gov/about/acrwh/
index.asp. The meeting will be live-video
streamed at https://videocast.nih.gov/.
Individuals who plan to attend the meeting
in person should contact Faith Zeff at
faith.zeff@nih.gov. Members of the media
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will also need to register. In the interest of
security, NIH has instituted stringent
procedures for entrance onto the NIH
campus. All visitor vehicles, including
taxicabs, hotel, and airport shuttles will be
inspected before being allowed on campus.
Visitors will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: March 13, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–06267 Filed 3–18–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
SUMMARY:
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14391
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa-10
et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at Section
2114 of the PHS Act or as set forth at
42 CFR 100.3, as applicable. This Table
lists for each covered childhood vaccine
the conditions that may lead to
compensation and, for each condition,
the time period for occurrence of the
first symptom or manifestation of onset
or of significant aggravation after
vaccine administration. Compensation
may also be awarded for conditions not
listed in the Table and for conditions
that are manifested outside the time
periods specified in the Table, but only
if the petitioner shows that the
condition was caused by one of the
listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa-12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
February 1, 2015, through February 28,
2015. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
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]]>Agencies
[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Notices]
[Pages 14390-14391]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06270]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the National
Institute of Diabetes and Digestive and Kidney Diseases Special
Emphasis Panel, March 31, 2015, 04:00 p.m. to April 01, 2015, 05:00
p.m., Churchill Hotel, 1914 Connecticut Avenue NW., Washington, DC,
20009 which was published in the Federal Register on March 09, 2015, 80
FR 12494.
The meeting is being amended to reflect location change. The new
meeting location is the Hyatt Regency Bethesda, One Bethesda Metro
Center, Bethesda, MD 20814. The meeting is closed to the public.
[[Page 14391]]
Dated: March 13, 2015.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-06270 Filed 3-18-15; 8:45 am]
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