Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 75689 

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. 

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. 

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 

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 

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 


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, 

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 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

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 


jdjones on DSK8KYBLC1PROD with NOTICES