National Advisory Council on Nurse Education and Practice; Notice for Request for Nominations, 75689-75690 [2010-30445]
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Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices
reclassification, and has availed itself of
two opportunities to comment on and
object to FDA’s proposal: (1) On August
9, 2000, in response to FDA’s May 2000
proposal, and (2) on April 28, 2003, in
response to FDA’s NOOH (68 FR 8908).
FDA has not deprived Delmont of fair
notice, nor has FDA precluded Delmont
from seeking judicial review.
D. Denial of Hearing Request
For the reasons stated previously in
this document, the Commissioner of
Food and Drugs (Commissioner)
determines that Delmont has failed to
raise a genuine and substantial issue of
fact to justify a hearing on the proposed
revocation of U.S. License No. 299
issued to Delmont Laboratories, Inc. for
Polyvalent Bacterial Antigens with ‘‘no
U.S. Standard of Potency’’ (Staphage
Lysate), and, therefore, denies
Delmont’s request for a hearing. The
Commissioner also determines that
Delmont’s procedural arguments do not
provide a basis for a hearing.
jdjones on DSK8KYBLC1PROD with NOTICES
IV. Categorization of Products—Final
Order
The Commissioner has considered all
relevant information regarding the four
Category IIIA bacterial vaccines and
bacterial antigens subject to
reclassification and concludes that
FDA’s proposal for the reclassification
of Category IIIA products into Category
I or Category II is adopted as set forth
in this section of this document and
hereby formally classifies:
Category I—Biological products
determined to be safe, effective, and not
misbranded, and which may continue to
be introduced into interstate commerce.
Sanofi Pasteur Inc., U.S. License No.
1725:
Tetanus Toxoid Adsorbed (primary
and booster use), and
Tetanus and Diphtheria Toxoids
Adsorbed For Adult Use
(DECAVACTM) (primary and
booster use).
Category II—Biological products
determined to be unsafe, ineffective, or
misbranded, and which may not
continue to be introduced into interstate
commerce.
Delmont Laboratories Inc., U.S. License
No. 299:
Polyvalent Bacterial Antigens with
‘‘No U.S. Standard of Potency’’
Staphage Lysate® (SPL)
V. License Revocation—Final Order
For the reasons set forth in this
document, under section 351 of the
Public Health Service Act (42 U.S.C.
262) and 21 CFR 601.5(b)(1)(vi), the
Commissioner revokes the license (U.S.
VerDate Mar<15>2010
15:27 Dec 03, 2010
Jkt 223001
License No. 299) issued to Delmont
Laboratories, Inc., for Polyvalent
Bacterial Antigens with ‘‘No U.S.
Standard of Potency’’ Staphage Lysate®
(SPL).
VI. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Final Report: Addendum to Previous
Panel Reports for the Reclassification of
Category IIIA Biologics, VRBPAC, 1984.
2. Fujino, Ryuichi; Yuji Sugisaki; Junko
Nakagawa; Masana Komatsu; and
Hachihiko Hirayama, ‘‘Chronic Toxicity
Test of SPL in Rats,’’ Fujizoki
Pharmaceutical Co., Ltd., Shinjuku-ku,
Tokyo.
3. Fujino, Ryuichi; Yuji Sugisaki; Junko
Nakagawa; Masana Komatsu; ‘‘Acute and
Subacute Toxicity Tests of SPL,’’ Fujizoki
Pharmaceutical Co., Ltd., Shinjuku-ku,
Tokyo.
4. Hirayama, Hachihiko, ‘‘Teratologenicity
Study of SPL in Rats and Rabbits,’’
Fujizoki Pharmaceutical Co., Ltd.,
Nerima-ku, Tokyo.
5. ‘‘Effect of SPL on the Development of
Skin Lesion in Mice after Inoculation
with Herpes Simplex Virus,’’ Department
of Microbiology, School of Medicine,
Kyushu University, Fukuoka, Japan.
6. ‘‘Chemotactic Accumulation of
Macrophages in the Peritoneal Cavity
after Inoculation of SPL and their
Antitumor Activity,’’ Department of
Microbiology, School of Medicine,
Kyushu University, Fukuoka, Japan.
7. ‘‘S–27: Summary of Results of Tests
Conducted at Fuji-Zoki Pharmaceutical
Research Division,’’ Fujizoki
Pharmaceutical Co., Ltd., Tokyo.
8. Shigeno, N.; T. Mitsuma; and K. Kojima,
‘‘Susceptibility of Staphylococcus aureus
Clinical Isolates to Gratia Bacteriophage,’’
Junior College of Medical Technology
and Nursing affiliated with Niigata
University.
9. Mitsuma, T.; N. Shigeno; K. Kojima; and
M. Tanaka, ‘‘Influence of Staphage
Lysates (SPL) on Immune Responses In
Vitro,’’ Junior College of Medical
Technology and Nursing affiliated with
Niigata University and Santo Hospital.
10. Azuma, C.; Y. Tokuda; and T. Shibata,
‘‘Immunopotiator Activity of Staphage
Lysate (Mudd),’’ Department of
Dermatology, Tokyo College of Medicine,
Tokyo.
11. Tsuda, Shingo and Kikuo Minami,
‘‘Immunochemotherapy for Infections—
With Particular Reference to Staphage
Lysate,’’ Department of Dermatology,
Kurume University, School of Medicine,
Kurume, Fukuoka Prefecture.
12. Salmon, G.G. and M. Symonds,
‘‘Staphage Lysate Therapy in Chronic
Staphylococcal Infections,’’ Journal of
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
75689
the Medical Society of New Jersey,
60:180–193 (1963).
13. Rank, Dale, ‘‘Immune Stimulation
Therapy for Inflammatory Disease of the
Gut,’’ and ‘‘Immune Stimulation for
Aphthous (Herpetic) Stomatitis &
Rhinitis,’’ (Study Nov. 1975 to Dec.
1977).
14. Rank, Dale, ‘‘Immune Stimulation for
Aphthous (Herpetic) Stomatitis &
Rhinitis,’’ (Jan. 1976 to Jan. 1978).
Dated: November 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30441 Filed 12–3–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Nurse
Education and Practice; Notice for
Request for Nominations
The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill eight
vacancies on the National Advisory
Council on Nurse Education and
Practice (NACNEP).
SUMMARY:
Authority: 42 U.S.C. 297t, section 851 of
the Public Health Service (PHS) Act, as
amended by the Affordable Care Act. The
NACNEP is governed by the Federal
Advisory Committee Act, Public Law (Pub.
L.) 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
The Agency must receive
nominations on or before December 22,
2010. Addresses: All nominations are to
be submitted either by mail to Lakisha
Smith, MPH, Designated Federal
Official, NACNEP, Division of Nursing,
Bureau of Health Professions (BHPr),
Health Resources and Services
Administration (HRSA), Parklawn
Building, Room 9B–45, 5600 Fishers
Lane, Rockville, MD 20857 or e-mail at
Lsmith2@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: For
additional information contact, Lakisha
Smith, Executive Secretary, National
Advisory Council on Nurse Education
and Practice, by e-mail at
Lsmith2@hrsa.gov or telephone at (301)
443–5688. A copy of the current
committee membership, charter and
reports can be obtained by accessing the
NACNEP Web site at https://
bhpr.hrsa.gov/nursing/nacnep.htm.
SUPPLEMENTARY INFORMATION: Under the
authorities that established the NACNEP
and the Federal Advisory Committee
Act, HRSA is requesting nominations
DATES:
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jdjones on DSK8KYBLC1PROD with NOTICES
75690
Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices
for eight committee members. The
NACNEP advises and makes
recommendations to the Secretary and
Congress on policy matters arising in
the administration of Title VIII,
including the range of issues relating to
the nurse workforce, nursing education
and nursing practice improvement. The
Advisory Council may make specific
recommendations to the Secretary and
Congress regarding programs
administered by the Division of
Nursing, Bureau of Health Professions,
Health Resources and Services
Administration. The Advisory Council
provides advice to the Secretary and
Congress in preparation of general
regulations and with respect to policy
matters in the administration of this
Title including the range of issues
relating to nurse supply, education, and
practice improvement. The Advisory
Council shall annually prepare and
submit to the Secretary, the Committee
on Health, Education, Labor, and
Pensions of the Senate and the
Committee on Energy and Commerce of
the House of Representatives, a report
describing the activities of the Advisory
Council including its findings and
recommendations.
The Department of Health and Human
Services is requesting a total of eight
nominations for members of the
NACNEP who represent any of the
following groups: Full-time students
representing various levels of education
in schools of nursing; the general
public; practicing professional nurses;
leading authorities in the various fields
of nursing, higher secondary education
and associate degree schools of nursing;
and representatives of advanced
education nursing groups (such as nurse
practitioners, nurse midwives, and
nurse anesthetists), hospitals, and other
institutions and organizations which
provide nursing services. The majority
of members of the fully constituted
Council shall be nurses.
The Department is legally required to
ensure that the membership of HHS
Federal advisory committees is fairly
balanced in terms of points of view
represented and the functions to be
performed by the advisory committee.
Every effort is made to ensure that the
views of women, all ethnic and racial
groups, and people with disabilities are
represented on all HHS Federal advisory
committees and, therefore the
Department encourages nominations of
qualified candidates from these groups.
The Department also encourages
geographic diversity in Council
composition. Appointment to this
Council shall be made without
discrimination on the basis of age, race,
ethnicity, gender, sexual orientations,
VerDate Mar<15>2010
15:27 Dec 03, 2010
Jkt 223001
disability, culture, religion or
socioeconomic status.
Interested persons may nominate one
or more qualified persons for
membership. Self-nominations are also
accepted. Nominations must be
typewritten. The following information
should be included in the package of
materials submitted for each individual
being nominated: (1) A letter of
nomination that clearly states the name
and affiliation of the nominee, the basis
for the nomination (i.e., specific
attributes that qualify the nominee for
services in this capacity as described
above), a statement that the nominee is
willing to serve as a member of the
NACNEP and appears to have no
conflict of interest that would preclude
this Council membership. Potential
candidates will be asked to provide
detailed information concerning such
matters as financial holdings,
consultancies, research grants, and/or
contracts to permit an evaluation of
possible sources of conflicts of interest;
and (2) the nominator’s name, address
and daytime telephone number; the
home/or work address, and telephone
number; and finally, the e-mail address
of the individual being nominated.
HRSA requests inclusion of a current
copy of the nominee’s curriculum vitae
and a statement of interest from the
nominee which demonstrates
experience working with or interest in
Title VIII nursing programs; expertise in
the field (if applying as a nursing
candidate) or understanding of nursing
issues (if applying as a general public
candidate); and a personal desire to
participate on a National Advisory
Council. Members will receive a stipend
for each day (including travel time)
during which they are in attendance at
official meetings of the Council, as well
as per diem and travel expenses as
authorized by section 5 U.S.C. 5703 for
persons employed intermittently in
government service. Qualified
candidates will be invited to serve a
four-year term.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
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 meeting.
The meeting 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: Center for Scientific
Review Special Emphasis Panel Member
Conflict: Cancer Immunotherapy.
Date: December 13, 2010.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call).
Contact Person: Syed M. Quadri, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6210,
MSC 7804, Bethesda, MD 20892. 301–435–
1211. quadris@csr.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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 29, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–30458 Filed 12–3–10; 8:45 am]
BILLING CODE 4140–01–P
Dated: November 30, 2010.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–30445 Filed 12–3–10; 8:45 am]
National Institutes of Health
BILLING CODE 4165–15–P
National Cancer Institute; Notice of
Meeting
PO 00000
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
National Cancer Institute Clinical Trials
Frm 00029
Fmt 4703
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06DEN1
Agencies
[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75689-75690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30445]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Council on Nurse Education and Practice; Notice
for Request for Nominations
SUMMARY: The Health Resources and Services Administration (HRSA) is
requesting nominations to fill eight vacancies on the National Advisory
Council on Nurse Education and Practice (NACNEP).
Authority: 42 U.S.C. 297t, section 851 of the Public Health
Service (PHS) Act, as amended by the Affordable Care Act. The NACNEP
is governed by the Federal Advisory Committee Act, Public Law (Pub.
L.) 92-463, as amended (5 U.S.C. Appendix 2), which sets forth
standards for the formation and use of advisory committees.
DATES: The Agency must receive nominations on or before December 22,
2010. Addresses: All nominations are to be submitted either by mail to
Lakisha Smith, MPH, Designated Federal Official, NACNEP, Division of
Nursing, Bureau of Health Professions (BHPr), Health Resources and
Services Administration (HRSA), Parklawn Building, Room 9B-45, 5600
Fishers Lane, Rockville, MD 20857 or e-mail at Lsmith2@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: For additional information contact,
Lakisha Smith, Executive Secretary, National Advisory Council on Nurse
Education and Practice, by e-mail at Lsmith2@hrsa.gov or telephone at
(301) 443-5688. A copy of the current committee membership, charter and
reports can be obtained by accessing the NACNEP Web site at https://bhpr.hrsa.gov/nursing/nacnep.htm.
SUPPLEMENTARY INFORMATION: Under the authorities that established the
NACNEP and the Federal Advisory Committee Act, HRSA is requesting
nominations
[[Page 75690]]
for eight committee members. The NACNEP advises and makes
recommendations to the Secretary and Congress on policy matters arising
in the administration of Title VIII, including the range of issues
relating to the nurse workforce, nursing education and nursing practice
improvement. The Advisory Council may make specific recommendations to
the Secretary and Congress regarding programs administered by the
Division of Nursing, Bureau of Health Professions, Health Resources and
Services Administration. The Advisory Council provides advice to the
Secretary and Congress in preparation of general regulations and with
respect to policy matters in the administration of this Title including
the range of issues relating to nurse supply, education, and practice
improvement. The Advisory Council shall annually prepare and submit to
the Secretary, the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce of the House of
Representatives, a report describing the activities of the Advisory
Council including its findings and recommendations.
The Department of Health and Human Services is requesting a total
of eight nominations for members of the NACNEP who represent any of the
following groups: Full-time students representing various levels of
education in schools of nursing; the general public; practicing
professional nurses; leading authorities in the various fields of
nursing, higher secondary education and associate degree schools of
nursing; and representatives of advanced education nursing groups (such
as nurse practitioners, nurse midwives, and nurse anesthetists),
hospitals, and other institutions and organizations which provide
nursing services. The majority of members of the fully constituted
Council shall be nurses.
The Department is legally required to ensure that the membership of
HHS Federal advisory committees is fairly balanced in terms of points
of view represented and the functions to be performed by the advisory
committee. Every effort is made to ensure that the views of women, all
ethnic and racial groups, and people with disabilities are represented
on all HHS Federal advisory committees and, therefore the Department
encourages nominations of qualified candidates from these groups. The
Department also encourages geographic diversity in Council composition.
Appointment to this Council shall be made without discrimination on the
basis of age, race, ethnicity, gender, sexual orientations, disability,
culture, religion or socioeconomic status.
Interested persons may nominate one or more qualified persons for
membership. Self-nominations are also accepted. Nominations must be
typewritten. The following information should be included in the
package of materials submitted for each individual being nominated: (1)
A letter of nomination that clearly states the name and affiliation of
the nominee, the basis for the nomination (i.e., specific attributes
that qualify the nominee for services in this capacity as described
above), a statement that the nominee is willing to serve as a member of
the NACNEP and appears to have no conflict of interest that would
preclude this Council membership. Potential candidates will be asked to
provide detailed information concerning such matters as financial
holdings, consultancies, research grants, and/or contracts to permit an
evaluation of possible sources of conflicts of interest; and (2) the
nominator's name, address and daytime telephone number; the home/or
work address, and telephone number; and finally, the e-mail address of
the individual being nominated. HRSA requests inclusion of a current
copy of the nominee's curriculum vitae and a statement of interest from
the nominee which demonstrates experience working with or interest in
Title VIII nursing programs; expertise in the field (if applying as a
nursing candidate) or understanding of nursing issues (if applying as a
general public candidate); and a personal desire to participate on a
National Advisory Council. Members will receive a stipend for each day
(including travel time) during which they are in attendance at official
meetings of the Council, as well as per diem and travel expenses as
authorized by section 5 U.S.C. 5703 for persons employed intermittently
in government service. Qualified candidates will be invited to serve a
four-year term.
Dated: November 30, 2010.
Robert Hendricks,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-30445 Filed 12-3-10; 8:45 am]
BILLING CODE 4165-15-P