67148 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 

Under 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drug was withdrawn from sale for 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.

DYCLONE (dyclonine HCl) 0.5% and 

1.0% Topical Solutions were the subject 

of approved NDA 9–925 held by 

AstraZeneca LP. DYCLONE Topical 

Solutions were labeled for anesthetizing 

accessible mucus membranes prior to 

various endoscopic procedures. 

DYCLONE 0.5% Topical Solution was 

also labeled to block the gag reflex, to 

relieve the pain of oral ulcers or 

stomatitis, and to relieve pain associated 

with ano-genital lesions.

In a citizen petition dated February 3, 

2004 (Docket No. 2004P–0051/CP1), 

submitted under 21 CFR 10.25(a) and 

10.30, Arent Fox, PLLC, requested that 

the agency determine whether 

DYCLONE (dyclonine HCl) 0.5% and 

1.0% Topical Solutions were withdrawn 

from the market for reasons of safety or 

effectiveness. In the Federal Register of 

February 11, 2002 (67 FR 6264), FDA 

withdrew approval of NDA 9–925 for 

DYCLONE 0.5% and 1.0% Topical 

Solutions after AstraZeneca notified the 

agency that DYCLONE was no longer 

being marketed under NDA 9–925 and 

requested withdrawal of that 

application.

The agency has determined that 

DYCLONE 0.5% and 1.0% Topical 

Solutions were not withdrawn from sale 

for reasons of safety or effectiveness. 

The petitioner identified no data or 

other information suggesting that 

DYCLONE was withdrawn from sale as 

a result of safety or effectiveness 

concerns. FDA has independently 

evaluated relevant literature and data 

for adverse event reports and has found 

no information that would indicate that 

these products were withdrawn from 

sale for reasons of safety or 

effectiveness.

After considering the citizen petition 

and reviewing agency records, FDA 

determines that, for the reasons outlined 

in this notice, dyclonine HCl 0.5% and 

1.0% topical solutions approved under 

NDA 9–925 were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the agency 

will continue to list DYCLONE 

(dyclonine HCl) 0.5% and 1.0% Topical 

Solutions 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 DYCLONE 

(dyclonine HCl) 0.5% and 1.0% Topical 

Solutions may be approved by the 

agency.

Dated: November 8, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–25332 Filed 11–15–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13), the Health 

Resources and Services Administration 

(HRSA) publishes periodic summaries 

of proposed projects being developed 

for submission to OMB under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, call the HRSA Reports 

Clearance Officer on (301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Free Clinic—FTCA 

Deeming Application (OMB No. 0915–

0293)—Extension 

Congress legislated FTCA medical 

malpractice protection for free clinic 

volunteer health professionals through 

section 194 of the Health Insurance 

Portability and Accountability Act 

(HIPAA) amending Section 224 of the 

Public Health Service Act. Individuals 

eligible to participate in this program 

are health care practitioners 

volunteering at free clinics who meet 

specific eligibility requirements. If an 

individual meets all the requirements of 

this program they can be ‘‘deemed’’ to 

be a Federal employee. This deemed 

status is specifically to provide 

immunity from medical malpractice 

lawsuits as a result of the performance 

of medical, surgical, dental, or related 

activities within the scope of the 

volunteer’s work at the free clinic. 

The sponsoring free clinic entity must 

submit an application to the Health 

Resources and Services Administration 

(HRSA). This application will require 

information about the sponsoring free 

clinic’s credentialing system, risk 

management practices, and quality 

assurance system in order to ensure the 

Government is not exposed to undue 

liability resulting from the medical 

malpractice coverage of non-qualified 

health care professionals. Attached to 

the application will be a listing of 

specific health care providers for whom 

the sponsoring free clinic is requesting 

deemed status. 

Estimates of annualized reporting 

burden are as follows:

Type of form Number of

respondents 

Responses 

per

respondent 

Total

responses 

Hours per

response 

Total burden 

hours 

FTCA Deeming Application ................................................. 600 1 600 5 3,000 

Total .............................................................................. 600 ........................ 600 ........................ 3,000 

Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 67149

Send comments to Susan G. Queen, 

Ph.D., HRSA Reports Clearance Officer, 

Room 14–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of this notice.

Dated: November 8, 2004. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 04–25403 Filed 11–15–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

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 

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: National Cancer 

Institute Initial Review Group, Subcommittee 

D—Clinical Studies. 

Date: December 8–10, 2004. 

Time: 7 p.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Bethesda North Hotel and 

Conference Ctr., 5701 Marinelli Road, North 

Bethesda, MD 20852. 

Contact Person: William D. Merritt, PhD, 

Scientific Review Administrator, Research 

Programs Review Branch, National Cancer 

Institute, Division of Extramural Activities, 

6116 Executive Blvd., 8th Floor, Bethesda, 

MD 20892–8328, (301) 496–9767, 

wm63f@nih.gov.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS)

Dated: November 8, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–25345 Filed 11–15–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

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 

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: National Cancer 

Institute Initial Review Group Subcommittee 

C—Basic & Preclinical. 

Date: December 8–10, 2004. 

Time: 6 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Bethesda North Hotel and 

Conference Ctr., 5701 Marinelli Road, North 

Bethesda, MD 20852. 

Contact Person: Michael B. Small, PhD, 

Scientific Review Administrator, Research 

Programs Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, Room 8127, Bethesda, 

MD 20892, (301) 402–0996, 

smallm@mail.nih.gov.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS)

Dated: November 8, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–25350 Filed 11–15–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

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 

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: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Review of Research Project Cooperative 

Agreements (U01s). 

Date: December 9, 2004. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: Hotel Rouge, 1315 16th Street, NW., 

Washington, DC 20036. 

Contact Person: Keith A. Mintzer, PhD, 

Scientific Review Administrator, Review 

Branch, Division of Extramural Affairs, 

National Heart, Lung, and Blood Institute, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 7186, MSC 7924, Bethesda, MD 

20892, (301) 435–0280.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.389, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS)

Dated: November 8, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–25349 Filed 11–15–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

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 

meeting.