Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices 31939

fdadockets@oc.fda.gov. Comments

should be identified with the full title

of the draft guidance and the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

David N. Heller, Center for Veterinary

Medicine (HFV–510), Food and Drug

Administration, 8401 Muirkirk Rd.,

Laurel, MD 20708, 301–827–8156, email: dheller@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Section 512 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360b) requires FDA to determine

whether each new animal drug

proposed for use in food-producing

animals is safe and effective. In some

cases, the new animal drugs used in

food-producing animals have the

potential to adversely affect the health

of the humans who consume food

derived from these animals. The

sponsor of the new animal drug is

responsible for establishing the safety of

each new animal drug through

appropriate tests.

To determine human food safety of

new animal drugs, FDA evaluates the

information/data, identifies and

characterizes potential hazards, assesses

exposure levels and characterizes the

overall risk. Through this process, FDA

establishes an allowable daily intake

and tolerances (the amount of drug

residue allowed in tissues) for each

drug. Drug sponsors submit to FDA

analytical methods that are designed to

measure the concentration of the

proposed drug in the edible tissues at

the drug’s tolerances. Analytical

methods are used to monitor the

tolerances set by FDA. FDA reviews the

analytical methods during its review of

new animal drug applications (21 CFR

514.1(b)(7)).

Analytical methods may also be used

to monitor safe levels as established by

the agency. Under section 512(a)(4)(B)

of the act and 21 CFR 530.22, the agency

may establish a safe level for extra-label

use of a drug when the agency finds that

there is a reasonable probability that an

extra-label use may result in drug

residues in edible tissue of the treated

animals at a level that may present a

risk to the public health if it was above

the safe level. Under the same

provisions, FDA may require the

development of an acceptable analytical

method for the quantification of

residues above any safe level.

FDA issues guidance recommending

methods of analysis to potential

sponsors to foster timely and objective

review of proposed new animal drugs,

including the review of analytical

methods. In the Federal Register of

December 31, 1987 (52 FR 49589), FDA

announced the availability of a set of

eight guidance documents entitled

‘‘General Principles for Evaluating the

Safety of Compounds Used in FoodProducing Animals’’ (52 FR 49589);

revisions to one of the guidances were

announced in the Federal Register of

July 22, 1994 (59 FR 37499). These

guidances were designed to inform

sponsors of the scientific data that FDA

believes will provide an acceptable

basis for determining the safety of such

compounds, and for designing

analytical methods.

Part V in the above-mentioned set of

guidances, entitled ‘‘Guideline for

Approval of a Method of Analysis for

Residues,’’ recommended that sponsors

develop rugged methods of analysis

designed to exceed rather than meet the

minimal standards of acceptability. This

serves two purposes: (1) To lower the

number of method of analysis

submissions that pass desk review but

fail interlaboratory studies designed to

test their effectiveness, and (2) to

increase the precision and specificity of

safety determination by ensuring a

higher quality assay. The guidance then

explained the evaluation criteria and

data needed for approval of a method of

analysis.

The draft guidance entitled

‘‘Guidance for Industry: Mass

Spectrometry for Confirmation of the

Identity of Animal Drug Residues’’ is

designed to complement part V of

‘‘General Principles for Evaluating the

Safety of Compounds Used in FoodProducing Animals.’’ The purpose of

this document is to facilitate and

expedite coordination between FDA’s

Center for Veterinary Medicine (CVM)

and sponsors so the development,

evaluation, and application of

qualitative mass spectrometric methods

will be completed in a consistent and

timely manner.

This draft document is intended for

technical professionals familiar with

mass spectrometry. A glossary at the

end of the draft guidance defines key

terms used throughout the document.

This draft guidance should be used in

the development of new methods, the

review of methods submitted to CVM,

and in the laboratory trial of methods

submitted to CVM. The document also

should help in making decisions about

appropriate methodology in various

regulatory situations and ensuring

consistency in work done for CVM’s

purposes.

The draft guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). This

draft guidance describes the basic

principles the agency recommends for

development, evaluation, or application

of qualitative mass spectrometric

methods for confirming the identity of

new animal drug residues. 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 statute and regulations.

Information collection provisions

described in this guidance have been

approved under OMB control numbers

0910–0032 and 0910–0325.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

draft guidance by September 11, 2001.

Two copies of any 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. A copy of the draft guidance

and received comments may be seen in

the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

III. Electronic Access

Comments on the draft guidance may

be electronically submitted at http://

www.accessdata.fda.gov/scripts/oc/

dockets/comments/commentdocket.cfm.

Electronic copies of the draft guidance

and other guidances discussed in this

notice may be obtained at http://

www.fda.gov/cvm.

Dated: May 30, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–14813 Filed 6–12–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–297]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

31940 Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Existing collection in use

without an OMB control number; Title

of Information Collection: Request for

Employment Information; Form No.:

HCFA–R–297 (OMB# 0938–0787); Use:

This form is needed to determine

whether a beneficiary can enroll in Part

B Medicare and/or qualify for premium

reduction. This form is used by the

Social Security Administration to obtain

information from employers regarding

whether a Medicare beneficiary’s

coverage under a group health plan is

based on current employment.;

Frequency: On occasion; Affected

Public: Business or other for-profit;

Number of Respondents: 5,000; Total

Annual Responses: 5,000; Total Annual

Hours: 750.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s web site address at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC 20503.

Dated: June 5, 2001.

John P. Burke, III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–14884 Filed 6–12–01; 8:45 am]

BILLING CODE 4120–03–P

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, Pub.

L. 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: The National Health

Service Corps (NHSC) and Native

Hawaiian Health (NHH) Scholarship

Programs Data Collection Worksheets

(OMB No. 0915–0226)—Extension

The NHSC and NHH Scholarship

Programs were established to assure an

adequate supply of trained primary care

health professionals to the neediest

communities in the Health Professional

Shortage Areas (HPSAs) of the United

States. Under these programs, allopathic

physicians, osteopathic physicians,

dentists, nurse practitioners, nurse

midwives, physician assistants, and, if

needed by the NHSC or NHH program,

students of other health professions are

offered the opportunity to enter into a

contractual agreement with the

Secretary under which the Public

Health Service agrees to pay the total

school tuition, required fees, other

reasonable costs (ORC) and a stipend for

living expenses. In exchange, the

scholarship recipients agrees to provide

full-time clinical services at a site in a

federally designated HPSA.

In order to accurately determine the

amount of scholarship support that

students will need during their

academic training the Bureau of Primary

Health Care must contact each

scholars’s school for an estimate of

tuition, fees, and ORC. The Data

Collection Worksheet collects these

itemized costs for both resident and

nonresident students.

Estimated Burden Hours

HRSA form Number of respondents

Responses

per respondent

Total responsesHours per responsesTotal burden

hours

Worksheet ............................................................................ 600 1 600 .50 300

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: June 6, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–14866 Filed 6–12–01; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice of Meeting.