80 FR 14390 - National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 53 (March 19, 2015)

Page Range		14390-14391
FR Document		2015-06270

Federal Register, Volume 80 Issue 53 (Thursday, March 19, 2015)

[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Notices]
[Pages 14390-14391]
From the Federal Register Online  [www.thefederalregister.org]
[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]
BILLING CODE 4140-01-P

14390 Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices

Submit written comments to the email address CDER_Science_Needs@ Contact Person: Xiaodu Guo, MD, Ph.D.,
Division of Dockets Management (HFA– fda.hhs.gov. Scientific Review Officer, Review Branch,
305), Food and Drug Administration, DEA, NIDDK, National Institutes Of Health,
II. Comments Room 761, 6707 Democracy Boulevard,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Interested persons may submit either Bethesda, MD 20892–5452, (301) 594–4719,
electronic comments regarding the guox@extra.niddk.nih.gov.
FOR FURTHER INFORMATION CONTACT:
Ruth Barratt, Center for Drug Evaluation report to http://www.regulations.gov This notice is being published less than 15
and Research, Food and Drug and email address CDER_Science_ days prior to the meeting due to the timing
Needs@fda.hhs.gov, or written limitations imposed by the review and
Administration, 10903 New Hampshire
comments to the Division of Dockets funding cycle.
Ave., Bldg. 21, Rm. 4540, Silver Spring,
MD 20993–0002, 301–796–2600. Management (see ADDRESSES). It is only Name of Committee: National Institute of
necessary to send one set of comments. Diabetes and Digestive and Kidney Diseases
SUPPLEMENTARY INFORMATION: Special Emphasis Panel; Collaborative
Identify comments with the docket
I. Background number found in brackets in the Interdisciplinary Team Science in Diabetes
heading of this document. Received and Obesity (R24).
Since publication of the 2011 Date: April 6, 2015.
comments may be seen in the Division
‘‘Identifying CDER’s Science and Time: 2:30 p.m. to 4:30 p.m.
of Dockets Management between 9 a.m.
Research Needs’’ report, FDA has been Agenda: To review and evaluate grant
and 4 p.m., Monday through Friday, and
engaged in efforts to further assess and applications.
will be posted to the docket at http://
prioritize the needs articulated therein. Place: National Institutes of Health, Two
www.regulations.gov.
As part of these efforts, CDER’s Safety Democracy Plaza, 6707 Democracy
Research Interest Group (SRIG), a III. Electronic Access Boulevard, Bethesda, MD 20892, (Telephone
subcommittee of the Science Conference Call).
Persons with access to the Internet
Prioritization and Review Committee, Contact Person: Ann A. Jerkins, Ph.D.,
may obtain the report at http://
assessed CDER’s overall drug safety- Scientific Review Officer, Review Branch,
www.regulations.gov. DEA, NIDDK, National Institutes of Health,
related regulatory science needs in view
of FDA’s ongoing research efforts and Dated: March 13, 2015. Room 759, 6707 Democracy Boulevard,
highlighted areas that would benefit Leslie Kux, Bethesda, MD 20892–5452, 301–594–2242,
Associate Commissioner for Policy. jerkinsa@niddk.nih.gov.
from additional resources and
collaboration. [FR Doc. 2015–06288 Filed 3–18–15; 8:45 am] (Catalogue of Federal Domestic Assistance
The SRIG identified the following BILLING CODE 4164–01–P
Program Nos. 93.847, Diabetes,
seven overall needs for drug safety- Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
related regulatory science:
DEPARTMENT OF HEALTH AND Research; 93.849, Kidney Diseases, Urology
1. Improve access to postmarket data and Hematology Research, National Institutes
sources and explore the feasibility of HUMAN SERVICES
of Health, HHS)
their use in safety signal analyses
2. Improve risk assessment and National Institutes of Health Dated: March 13, 2015.
management strategies to reinforce the David Clary,
National Institute of Diabetes and
safe use of drugs Digestive and Kidney Diseases; Notice Program Analyst, Office of Federal Advisory
3. Evaluate the effectiveness of risk Committee Policy.
of Closed Meetings
communications of drug safety [FR Doc. 2015–06266 Filed 3–18–15; 8:45 am]
information to health care providers and Pursuant to section 10(d) of the BILLING CODE 4140–01–P
the public Federal Advisory Committee Act, as
4. Improve product quality and amended (5 U.S.C. App.), notice is
design, manufacturing processes, and hereby given of the following meetings. DEPARTMENT OF HEALTH AND
product performance relating to safety The meetings will be closed to the HUMAN SERVICES
5. Develop and improve predictive public in accordance with the
models of safety in humans, including provisions set forth in sections National Institutes of Health
nonclinical biomarkers 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
6. Improve clinical trial statistical as amended. The grant applications and National Institute of Diabetes and
analyses for safety, including benefit- the discussions could disclose Digestive and Kidney Diseases;
risk assessment confidential trade secrets or commercial Amended Notice of Meeting
7. Investigate clinical biomarkers of property such as patentable material,
safety, including standards for and personal information concerning Notice is hereby given of a change in
qualification. individuals associated with the grant the meeting of the National Institute of
Particular priorities within the seven applications, the disclosure of which Diabetes and Digestive and Kidney
overall needs requiring further resources would constitute a clearly unwarranted Diseases Special Emphasis Panel, March
and outside participation were also invasion of personal privacy. 31, 2015, 04:00 p.m. to April 01, 2015,
identified. FDA seeks to stimulate 05:00 p.m., Churchill Hotel, 1914
Name of Committee: National Institute of
collaborations with external partners Diabetes and Digestive and Kidney Diseases
Connecticut Avenue NW., Washington,
and stakeholders to address these needs Special Emphasis Panel; NIDDK Ancillary DC, 20009 which was published in the
by asking them to: (1) Submit R01 Telephone Review SEP. Federal Register on March 09, 2015, 80
Rmajette on DSK2VPTVN1PROD with NOTICES

descriptions of their ongoing research Date: April 3, 2015 FR 12494.
and initiatives related to the seven Time: 2:30 p.m. to 3:30 p.m. The meeting is being amended to
Agenda: To review and evaluate grant
overall needs, especially the identified applications.
reflect location change. The new
priorities, and (2) indicate their interest Place: National Institutes of Health, Two meeting location is the Hyatt Regency
in working with FDA to address these Democracy Plaza, 6707 Democracy Bethesda, One Bethesda Metro Center,
needs. Outside parties are being asked Boulevard, Bethesda, MD 20892, (Telephone Bethesda, MD 20814. The meeting is
to submit comments to the docket and Conference Call). closed to the public.

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Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices 14391

Dated: March 13, 2015. will also need to register. In the interest of Lane, Room 11C–26, Rockville, MD
David Clary, security, NIH has instituted stringent 20857; (301) 443–6593.
procedures for entrance onto the NIH
Program Analyst, Office of Federal Advisory SUPPLEMENTARY INFORMATION: The
campus. All visitor vehicles, including
Committee Policy. Program provides a system of no-fault
taxicabs, hotel, and airport shuttles will be
[FR Doc. 2015–06270 Filed 3–18–15; 8:45 am] inspected before being allowed on campus. compensation for certain individuals
BILLING CODE 4140–01–P Visitors will be asked to show one form of who have been injured by specified
identification (for example, a government- childhood vaccines. Subtitle 2 of Title
issued photo ID, driver’s license, or passport) XXI of the PHS Act, 42 U.S.C. 300aa-10
DEPARTMENT OF HEALTH AND and to state the purpose of their visit. et seq., provides that those seeking
HUMAN SERVICES (Catalogue of Federal Domestic Assistance compensation are to file a petition with
Program Nos. 93.14, Intramural Research the U.S. Court of Federal Claims and to
National Institutes of Health Training Award; 93.22, Clinical Research serve a copy of the petition on the
Loan Repayment Program for Individuals Secretary of Health and Human
Office of the Director, National from Disadvantaged Backgrounds; 93.232,
Institutes of Health; Notice of Meeting Loan Repayment Program for Research
Services, who is named as the
Generally; 93.39, Academic Research respondent in each proceeding. The
Pursuant to section 10(a) of the Enhancement Award; 93.936, NIH Acquired Secretary has delegated this
Federal Advisory Committee Act, as Immunodeficiency Syndrome Research Loan responsibility under the Program to
amended (5 U.S.C. App.), notice is Repayment Program; 93.187, Undergraduate HRSA. The Court is directed by statute
hereby given of a meeting of the Scholarship Program for Individuals from to appoint special masters who take
Advisory Committee on Research on Disadvantaged Backgrounds, National evidence, conduct hearings as
Women’s Health. Institutes of Health, HHS) appropriate, and make initial decisions
The meeting will be open to the Dated: March 13, 2015. as to eligibility for, and amount of,
public, with attendance limited to space Carolyn Baum, compensation.
available. Individuals who plan to Program Analyst, Office of Federal Advisory A petition may be filed with respect
attend and need special assistance, such Committee Policy. to injuries, disabilities, illnesses,
as sign language interpretation or other [FR Doc. 2015–06267 Filed 3–18–15; 8:45 am] conditions, and deaths resulting from
reasonable accommodations, should BILLING CODE 4140–01–P
vaccines described in the Vaccine Injury
notify the Contact Person listed below Table (the Table) set forth at Section
in advance of the meeting. 2114 of the PHS Act or as set forth at
Name of Committee: Advisory Committee DEPARTMENT OF HEALTH AND 42 CFR 100.3, as applicable. This Table
on Research on Women’s Health. HUMAN SERVICES lists for each covered childhood vaccine
Date: April 10, 2014. the conditions that may lead to
Time: 9:00 a.m. to 4:00 p.m. Health Resources and Services compensation and, for each condition,
Agenda: The Committee serves to advise Administration the time period for occurrence of the
and make recommendations to the Director, first symptom or manifestation of onset
Office of Research on Women’s Health National Vaccine Injury Compensation or of significant aggravation after
(ORWH) on a broad range of topics including, Program; List of Petitions Received
the current scope of research on women’s
vaccine administration. Compensation
health and the influence of sex and gender may also be awarded for conditions not
AGENCY: Health Resources and Services
on human health, efforts to understand the listed in the Table and for conditions
Administration, HHS.
issues related to women in biomedical that are manifested outside the time
careers and their needs, and the current ACTION: Notice. periods specified in the Table, but only
status of inclusion of women in clinical trials if the petitioner shows that the
research. SUMMARY: The Health Resources and condition was caused by one of the
Place: National Institutes of Health, Services Administration (HRSA) is listed vaccines.
Building 35, Room 620/630, 35 Convent publishing this notice of petitions Section 2112(b)(2) of the PHS Act, 42
Drive, Bethesda, MD 20892. received under the National Vaccine
Contact Person: Susan E Maier, Ph.D., NIH/
U.S.C. 300aa-12(b)(2), requires that
Injury Compensation Program (the ‘‘[w]ithin 30 days after the Secretary
OD, 6707 Democracy Blvd., Room 400, Program), as required by Section
Bethesda, MD 20852, 301–435–1573, receives service of any petition filed
maiers@mail.nih.gov.
2112(b)(2) of the Public Health Service under section 2111 the Secretary shall
Any interested person may file written (PHS) Act, as amended. While the publish notice of such petition in the
comments for the public record by Secretary of Health and Human Services Federal Register.’’ Set forth below is a
submitting their comments to the following is named as the respondent in all list of petitions received by HRSA on
email address ACRWHComments@ proceedings brought by the filing of February 1, 2015, through February 28,
sp10mail.nih.gov. Written comments for the petitions for compensation under the 2015. This list provides the name of
public record must not exceed two single- Program, the United States Court of
spaced, typed pages, using a 12-point
petitioner, city and state of vaccination
Federal Claims is charged by statute (if unknown then city and state of
typeface and 1 inch margins; it is preferred with responsibility for considering and
that the document be prepared in the MS person or attorney filing claim), and
Word® format. Only testimony submitted to
acting upon the petitions. case number. In cases where the Court
this Web site and received in advance of the FOR FURTHER INFORMATION CONTACT: For has redacted the name of a petitioner
meeting are part of the official meeting information about requirements for and/or the case number, the list reflects
record. filing petitions, and the Program in such redaction.
Rmajette on DSK2VPTVN1PROD with NOTICES

Supplementary Information: A draft general, contact the Clerk, United States Section 2112(b)(2) also provides that
agenda for this meeting is posted at Court of Federal Claims, 717 Madison the special master ‘‘shall afford all
http://orwh.od.nih.gov/about/acrwh/
index.asp. The meeting will be live-video
Place NW., Washington, DC 20005, interested persons an opportunity to
streamed at http://videocast.nih.gov/. (202) 357–6400. For information on submit relevant, written information’’
Individuals who plan to attend the meeting HRSA’s role in the Program, contact the relating to the following:
in person should contact Faith Zeff at Director, National Vaccine Injury 1. The existence of evidence ‘‘that
faith.zeff@nih.gov. Members of the media Compensation Program, 5600 Fishers there is not a preponderance of the

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Document Created: 2018-02-21 09:42:07
Document Modified: 2018-02-21 09:42:07

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 14390

80 FR 14390 - National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 53 (March 19, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health