Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 67147

rates of interest prevailing on the date 

that HHS becomes entitled to recovery. 

The rate generally cannot be lower than 

the Department of Treasury’s current 

value of funds rate or the applicable rate 

determined from the ‘‘Schedule of 

Certified Interest Rates with Range of 

Maturities.’’ This rate may be revised 

quarterly by the Secretary of the 

Treasury and shall be published 

quarterly by the Department of Health 

and Human Services in the Federal 

Register. 

The Secretary of the Treasury has 

certified a rate of 12% for the quarter 

ended September 30, 2004. This interest 

rate will remain in effect until such time 

as the Secretary of the Treasury notifies 

HHS of the change.

Dated: November 8, 2004. 

George Strader, 

Deputy Assistant Secretary, Finance.

[FR Doc. 04–25357 Filed 11–15–04; 8:45 am] 

BILLING CODE 4150–02–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Low Income Home Energy 

Assistance Program (LIHEAP) Grantee 

Survey. 

OMB No.: 0970–0076. 

Description: The LIHEAP Grantee 

Survey is an annual data collection 

activity, which is sent to the 50 States 

and the District of Columbia grantees 

administering the Low Income Home 

Energy Assistance Program (LIHEAP). 

The survey is mandatory in order that 

national estimates of the sources and 

uses of LIHEAP funds can be calculated 

in a timely manner; a range can be 

calculated of state average LIHEAP 

benefits; and maximum income cutoffs 

for 4-person households can be obtained 

for estimating the number of lowincome households that are income 

eligible for LIHEAP under State income 

standards. 

Respondents: 50 States and the 

District of Columbia. 

Annual Burden Estimates:

Instrument Number of

respondents 

Number of

responses per 

respondent 

Average

burden hours

per response 

Total burden 

hours 

Survey .............................................................................................................. 51 1 3.4 173.4

Estimated Total Annual Burden 

Hours: 173.4. 

Additional Information: The need for 

the survey is to provide the 

Administration and Congress with fiscal 

estimates in time for hearings about 

LIHEAP appropriations and program 

performance. The information also is 

included in the Department’s annual 

LIHEAP Report to Congress. Survey 

information also will be posted on 

Office of Community Services LIHEAP 

web site for access by grantees and other 

interested parties. 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All request should be identified 

by the title of the information collection. 

E-mail address: grjohnson@acf.hhs.gov.

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Attn: Desk Officer for 

ACF, e-mail address: 

Katherine_T._Astrich@omb.eop.gov.

Dated: November 9, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–25341 Filed 11–15–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004P–0051]

Determination That DYCLONE 

(Dyclonine Hydrochloride) 0.5% and 

1.0% Topical Solutions Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that DYCLONE (dyclonine 

hydrochloride (HCl)) 0.5% and 1.0% 

Topical Solutions were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for 

DYCLONE HCl 0.5 and 1.0% Topical 

Solutions.

FOR FURTHER INFORMATION CONTACT:

Mary Catchings, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

sponsors must, with certain exceptions, 

show that the drug for which they are 

seeking approval contains the same 

active ingredient in the same strength 

and dosage form as the ‘‘listed drug,’’

which is a version of the drug that was 

previously approved. Sponsors of 

ANDAs do not have to repeat the 

extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug.

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

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 (21 CFR 314.162).

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