National Committee on Vital and Health Statistics: Meeting, 39531 [2010-16729]
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Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices
but not limited to service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant;
(2) that any institution that submits an
application for PHS support for a
research project on which the
Respondent’s participation is proposed
or that uses him in any capacity on
PHS-supported research, or that submits
a report of PHS-funded research in
which he is involved, must concurrently
submit a plan for supervision of his
duties to the funding agency for
approval; the supervisory plan must be
designed to ensure the scientific
integrity of his research contribution. A
copy of the supervisory plan also must
be submitted to ORI by the institution.
Respondent agreed that he will not
participate in any PHS-supported
research until such a supervisory plan is
submitted to ORI.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
John Dahlberg,
Director, Division of Investigative Oversight,
Office of Research Integrity.
[FR Doc. 2010–16824 Filed 7–8–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Meeting
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Name: National Committee on Vital and
Health Statistics (NCVHS) Standards
Subcommittee.
Time and Date: July 19, 2010 9 a.m.–5 p.m.
July 20, 2010 8:30 a.m.–5 p.m. July 21, 2010
9 a.m.–5 p.m. (committee discussion)
Place: Hamilton Crowne Plaza Hotel, 1001
14th Street, NW., Washington, DC 20005,
(202) 682–0111.
Status: Open.
Purpose: The purpose of this upcoming
meeting of the Subcommittee on Standards is
to receive industry input on a unique health
plan identifier to be used in HIPAA standard
transactions, and on new operating rules for
standards, and their authoring organizations.
The Subcommittee will hear testimony from
individuals, organizations and associations
on these matters. The subcommittee will
meet for three consecutive days for which a
variety of panels are scheduled; day one will
focus on the unique health plan identifier,
day two will concentrate on authoring
organizations and operating rules for
eligibility and health claim status, and day
15:17 Jul 08, 2010
Jkt 220001
Dated: June 29, 2010.
James Scanlon,
Deputy Assistant Secretary for Planning and
Evaluation, Science and Data Policy, Office
of the Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2010–16729 Filed 7–8–10; 8:45 am]
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
VerDate Mar<15>2010
three of the meeting will be reserved for
Subcommittee discussion and deliberation.
The NCVHS has been named in the Patient
Protection and Affordable Care Act (ACA) of
2010 to review and make recommendations
on several HIPAA standards and electronic
transactions. This meeting will support these
activities in the development of a set of
recommendations for the Secretary, as
required by section 1104 of the ACA. Text of
the ACA can be found at https://
dpc.senate.gov/dpcdocsen_health_care_bill.cfm.
Contact Person For More Information:
Substantive program information as well as
summaries of meetings and a roster of
committee members may be obtained from
Lorraine Doo, lead staff for the Standards
Subcommittee, NCVHS, Centers for Medicare
and Medicaid Services, Office of E-Health
Standards and Services, 7500 Security
Boulevard, Baltimore, Maryland, 21244,
telephone (410) 786–6597 or Marjorie S.
Greenberg, Executive Secretary, NCVHS,
National Center for Health Statistics, Centers
for Disease Control and Prevention, 3311
Toledo Road, Room 2402, Hyattsville,
Maryland 20782, telephone (301) 458–4245.
Information also is available on the NCVHS
home page of the HHS Web site: https://
www.ncvhs.hhs.gov/, where further
information including an agenda will be
posted when available.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment Opportunity on
(301) 458–4EEO (4336) as soon as possible.
Food and Drug Administration
[Docket No. FDA–2010–N–0174]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Applications for
Food and Drug Administration
Approval to Market a New Drug: Patent
Submission and Listing Requirements
and Application of 30-Month Stays on
Approval of Abbreviated New Drug
Applications Certifying That a Patent
Claiming a Drug Is Invalid or Will Not
Be Infringed
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
PO 00000
Frm 00039
Fmt 4703
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39531
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 9,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0513. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Applications for FDA Approval to
Market a New Drug: Patent Submission
and Listing Requirements and
Application of 30-Month Stays on
Approval of Abbreviated New Drug
Applications Certifying That a Patent
Claiming a Drug Is Invalid or Will Not
Be Infringed—OMB Control Number
0910–0513—Extension
Section 505(b)(1) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 355(b)(1)) requires all new drug
application (NDA) applicants to file, as
part of the NDA, ‘‘the patent number and
the expiration date of any patent which
claims the drug for which the applicant
submitted the application or which
claims a method of using such drug and
with respect to which a claim of patent
infringement could reasonably be
asserted if a person not licensed by the
owner engaged in the manufacture[,]
use, or sale of the drug.’’ Section
505(c)(2) of the act imposes a similar
patent submission obligation on holders
of approved NDAs when the NDA
holder could not have submitted the
patent information with its application.
Under section 505(b)(1) of the act, we
publish patent information after
approval of an NDA in the list entitled
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations’’
E:\FR\FM\09JYN1.SGM
09JYN1
Agencies
[Federal Register Volume 75, Number 131 (Friday, July 9, 2010)]
[Notices]
[Page 39531]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16729]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Committee on Vital and Health Statistics: Meeting
Pursuant to the Federal Advisory Committee Act, the Department of
Health and Human Services (HHS) announces the following advisory
committee meeting.
Name: National Committee on Vital and Health Statistics (NCVHS)
Standards Subcommittee.
Time and Date: July 19, 2010 9 a.m.-5 p.m. July 20, 2010 8:30
a.m.-5 p.m. July 21, 2010 9 a.m.-5 p.m. (committee discussion)
Place: Hamilton Crowne Plaza Hotel, 1001 14th Street, NW.,
Washington, DC 20005, (202) 682-0111.
Status: Open.
Purpose: The purpose of this upcoming meeting of the
Subcommittee on Standards is to receive industry input on a unique
health plan identifier to be used in HIPAA standard transactions,
and on new operating rules for standards, and their authoring
organizations. The Subcommittee will hear testimony from
individuals, organizations and associations on these matters. The
subcommittee will meet for three consecutive days for which a
variety of panels are scheduled; day one will focus on the unique
health plan identifier, day two will concentrate on authoring
organizations and operating rules for eligibility and health claim
status, and day three of the meeting will be reserved for
Subcommittee discussion and deliberation.
The NCVHS has been named in the Patient Protection and
Affordable Care Act (ACA) of 2010 to review and make recommendations
on several HIPAA standards and electronic transactions. This meeting
will support these activities in the development of a set of
recommendations for the Secretary, as required by section 1104 of
the ACA. Text of the ACA can be found at https://dpc.senate.gov/dpcdoc-sen_health_care_bill.cfm.
Contact Person For More Information: Substantive program
information as well as summaries of meetings and a roster of
committee members may be obtained from Lorraine Doo, lead staff for
the Standards Subcommittee, NCVHS, Centers for Medicare and Medicaid
Services, Office of E-Health Standards and Services, 7500 Security
Boulevard, Baltimore, Maryland, 21244, telephone (410) 786-6597 or
Marjorie S. Greenberg, Executive Secretary, NCVHS, National Center
for Health Statistics, Centers for Disease Control and Prevention,
3311 Toledo Road, Room 2402, Hyattsville, Maryland 20782, telephone
(301) 458-4245. Information also is available on the NCVHS home page
of the HHS Web site: https://www.ncvhs.hhs.gov/, where further
information including an agenda will be posted when available.
Should you require reasonable accommodation, please contact the
CDC Office of Equal Employment Opportunity on (301) 458-4EEO (4336)
as soon as possible.
Dated: June 29, 2010.
James Scanlon,
Deputy Assistant Secretary for Planning and Evaluation, Science and
Data Policy, Office of the Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2010-16729 Filed 7-8-10; 8:45 am]
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