69374 Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Notices 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness, or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (§ 314.162) (21 

CFR 314.162)).

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug.

The drug products 7.5% and 8.4% 

sodium bicarbonate injection in PET 

Abboject vials are the subject of 

approved NDA 19–443 held by Abbott 

Laboratories. The drug products 7.5% 

and 8.4% sodium bicarbonate injection 

in PET Abboject vials are indicated for 

the treatment of metabolic acidosis, 

certain drug overdosage, and severe 

diarrhea. The holder of the application 

for 7.5% and 8.4% sodium bicarbonate 

injection in PET Abboject vials 

requested a voluntary withdrawal and 

the marketing of the drug products was 

discontinued (61 FR 40649, August 5, 

1996). In a citizen petition dated March 

18, 2004 (Docket No. 2004P–0141), 

submitted under 21 CFR 10.30 and 

314.122, Abbott Laboratories requested 

that the agency determine whether 7.5% 

and 8.4% sodium bicarbonate injection 

in PET Abboject vials were withdrawn 

from sale for reasons of safety or 

effectiveness.

The agency has determined that 

Abbott Laboratories’ 7.5% and 8.4% 

sodium bicarbonate injection in PET 

Abboject vials were not withdrawn from 

sale for reasons of safety or 

effectiveness. FDA has independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

event reports and has found no 

information that would indicate that 

these products were withdrawn for 

reasons of safety or effectiveness.

For the reasons outlined, FDA 

determines that Abbott Laboratories’

7.5% and 8.4% sodium bicarbonate 

injection in PET Abboject vials were not 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

agency will continue to list 7.5% and 

8.4% sodium bicarbonate injection in 

the ‘‘Discontinued Drug Product List’’

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to 7.5% and 8.4% sodium bicarbonate 

injection may be approved by the 

agency.

Dated: November 18, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26271 Filed 11–26–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0484]

Draft Guidance for Industry on the 

Role of Human Immunodeficiency 

Virus Drug Resistance Testing in 

Antiretroviral Drug Development; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Role of HIV Drug 

Resistance Testing in Antiretroviral 

Drug Development.’’ This draft guidance 

is intended to assist sponsors in the 

clinical development of drugs for the 

treatment of human immunodeficiency 

virus (HIV) infection. Specifically, the 

draft guidance addresses the role of HIV 

resistance testing during antiretroviral 

drug development and postmarketing. 

The draft guidance is also intended to 

serve as a focus for continued 

discussions among the Division of 

Antiviral Drug Product (DAVDP) in 

FDA’s Center for Drug Evaluation and 

Research, pharmaceutical sponsors, the 

academic community, and the public.

DATES: Submit written or electronic 

comments on the draft guidance by 

February 28, 2005. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 

the Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Jeffrey S. Murray, or Kimberly A. 

Struble Center for Drug Evaluation and 

Research (HFD–530), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–2330.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Role of HIV Drug Resistance Testing in 

Antiretroviral Drug Development.’’ This 

draft guidance addresses the role of HIV 

resistance testing during antiretroviral 

drug development and postmarketing. 

The draft guidance is based on the 

following: (1) A 2-day session of the 

Antiviral Drug Product advisory 

committee convened November 2 and 3, 

1999, to address issues relating to HIV 

resistance testing; (2) the DAVDP’s 

experience with reviewing resistance 

data for antiretroviral drugs; and (3) 

input from pharmaceutical sponsors and 

the HIV community.

The draft guidance discusses the 

nonclinical studies (mechanism of 

action; antiviral activity in vitro; 

cytotoxicity/therapeutic index; and the 

effects of serum protein binding on 

antiviral activity) we recommend be 

completed prior to the initiation of 

phase 1 clinical studies in HIV-infected 

patients. In addition, the draft guidance 

addresses the use of resistance testing in 

the clinical phases of drug development 

and recommends the type of 

information that should be collected 

and the types of analyses that should be 

conducted to characterize an 

antiretroviral’s resistance profile. The 

draft guidance also reviews the role of 

resistance testing in initial activity and 

dose-finding, for study enrollment 

criteria, for background regimen 

selection, and to establish an indication. 

Included in this draft guidance are two 

appendices: (1) A template for 

submitting HIV resistance data and (2) 

information on the genetic threshold for 

resistance.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance represents the 

agency’s current thinking on the role of 

HIV resistance testing in antiretroviral 

drug development. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations.

Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Notices 69375

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3520). The collection of 

information in this guidance was 

approved under the OMB control 

number 0910–0014 (until January 31, 

2006).

IV. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: November 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26272 Filed 11–26–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Funding for the Pathways for Health 

Professions Program, HRSA–05–118

AGENCY: Health Resources and Services 

Administration, HHS.

ACTION: Notice of posting of availability 

of funds. 

SUMMARY: This notice announces the 

posting of a funding opportunity 

(Guidance HRSA–05–118) for the 

Pathways to Health Professions Program 

(PHPP) on the Health Resources and 

Services Administration (HRSA) 

Guidance and Fedgrants.gov Web sites. 

Funding is being made available for a 

competitive grant program that supports 

the continuation and development of 

innovative, culturally competent 

approaches that encourage 

underrepresented minority and 

disadvantaged students in colleges and 

universities, community colleges, 

elementary, middle, and high schools to 

pursue a career in a health or allied 

health field. This program consists of 

two distinct grants: (1) Primary 

Pathways—Promotes academic 

achievement and exposes students in 

grades K–12 to health and allied health 

professions through innovative, nontraditional methods, with an emphasis 

on health professions that are 

experiencing severe shortages across the 

country; and (2) Advanced Pathways—

Promotes academic achievement and 

exposes and prepares high school and 

undergraduate students to pursue 

careers in health and allied health 

professions, including faculty 

membership and research. 

Name of Grant Program: Pathways to 

Health Professions Program. 

Program Authorization: Section 739 

of the Public Health Service Act, 42 

U.S.C. 293. 

Amount of Funding Available:

$400,000. We expect that fiscal year 

2005 funding for the Primary Pathways 

Program will be approximately $200,000 

and approximately $200,000 for the 

Advanced Pathways grant program. It is 

anticipated that four awards will be 

made. 

Eligible Applicants: Eligible 

applicants are elementary, middle, and 

high schools, community colleges, 

colleges and universities, and 

institutions of higher education, nonprofit community-based organizations, 

including faith-based organizations, 

Tribes, Tribal organizations, and health 

or educational professional 

organizations. Eligible participants 

include underrepresented minorities, 

educationally and economically 

disadvantaged elementary, middle, high 

school, community college, and 

undergraduate students. They must be 

U.S. citizens, non-citizen nationals, or 

those foreign nationals who possess a 

visa permitting permanent residence in 

the U.S. 

Guidance Availability: Guidance 

availability is currently posted on the 

HRSA Web site at: http://www.hrsa.gov/

grants/preview/guidanceprofessions/

hrsa05118.htm and on Fedgrants.gov at: 

http://fedgrants.gov/Applicants/HHS/

HRSA/GAC/HRSA–05–118/listing.html.

Application Deadline: December 17, 

2004.

Dated: November 22, 2004. 

Elizabeth M. Duke, 

Administrator.

[FR Doc. 04–26274 Filed 11–26–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings 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: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, Udall Center Review. 

Date: December 2, 2004. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Joann McConnell, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NIH/NINDS/Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, (301) 

496–5324, mcconnej@ninds.nih.gov.

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, NINDS T32 Review. 

Date: December 7, 2004. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Joann McConnell, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NIH/NINDS/Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, (301) 

496–5324, mcconnej@ninds.nih.gov.

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, Neural Control of Motor 

Systems. 

Date: December 16, 2004. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call).