National Advisory Council on Nurse Education and Practice; Notice for Request for Nominations, 75689-75690 [2010-30445]

Download as PDF 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 http:// 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: E:\FR\FM\06DEN1.SGM 06DEN1 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 Sfmt 4703 E:\FR\FM\06DEN1.SGM 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 http://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