Federal Register / Vol. 65, No. 203 / Thursday, October 19, 2000 / Notices 62723

Location: Quality Suites, Potomac

Ballroom, 3 Research Ct., Rockville, MD.

Contact Person: Nancy Chamberlin or

Jaime Henriquez, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane (for express delivery, 5630

Fishers Lane, rm. 1093), Rockville, MD

20857, 301–827–7001, or e-mail:

CHAMBERLINN@cder.fda.gov, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12539 and

12534. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On November 17, 2000, the

committees will discuss the current

status of, and future plans for, the draft

FDA guidance entitled ‘‘A Guidance for

Industry, Topical Dermatological Drug

Product NDA’s and ANDA’s—In Vivo

Bioavailability, Bioequivalence, In Vitro

Release, and Associated Studies;’’ see

the FDA internet web address

www.fda.gov/cder/guidance/

2481dft.pdf under the heading of

‘‘Biopharmaceutics Draft Guidances.’’ A

proposed research program for

addressing scientific issues related to

this guidance will also be discussed.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by November 6, 2000. Oral

presentations from the public will be

scheduled between approximately 11:15

a.m. to 12:15 p.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before November 6, 2000, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 11, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–26898 Filed 10–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1532]

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH);

Draft Guidances for Industry on

‘‘Effectiveness of Anthelmintics:

Specific Recommendations for

Equine’’ (VICH GL15), ‘‘Effectiveness

of Anthelmintics: Specific

Recommendations for Porcine’’ (VICH

GL16), and ‘‘Effectiveness of

Anthelmintics: Specific

Recommendations for Canine’’ (VICH

GL19); Availability; Request for

Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability for comment of three draft

guidances for industry (Nos. 109, 110,

and 111, respectively) entitled:

‘‘Effectiveness of Anthelmintics:

Specific Recommendations for Equine’’

(VICH GL15), ‘‘Effectiveness of

Anthelmintics: Specific

Recommendations for Porcine’’ (VICH

GL16), and ‘‘Effectiveness of

Anthelmintics: Specific

Recommendations for Canine’’ (VICH

GL19). These related draft guidance

documents have been developed by the

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH).

They are intended to standardize and

simplify methods used in the evaluation

of new anthelmintics submitted for

approval to the European Union, Japan,

and the United States.

DATES: Submit written comments on the

draft guidances by December 18, 2000,

to ensure their adequate consideration

in preparation of the final guidance

document. General comments on agency

guidance documents are welcome at any

time.

ADDRESSES: Copies of the draft

guidances entitled ‘‘Effectiveness of

Anthelmintics: Specific

Recommendations for Equine’’ (VICH

GL15), ‘‘Effectiveness of Anthelmintics:

Specific Recommendations for Porcine’’

(VICH GL16), and ‘‘Effectiveness of

Anthelmintics: Specific

Recommendations for Canine’’ (VICH

GL19) may be obtained on the Internet

from the CVM home page at http://

www.fda.gov/cvm/fda/TOCs/

guideline.html. Persons without Internet

access may submit written requests for

single copies of the draft guidances to

the Communications Staff (HFV–12),

Center for Veterinary Medicine, Food

and Drug Administration, 7500 Standish

Place, Rockville, MD 20855. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Regarding the VICH: Sharon R.

Thompson, Center for Veterinary

Medicine (HFV–3), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1798, email: sthompso@cvm.fda.gov, or Carole

R. Andres, Center for Veterinary

Medicine (HFV–1), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–6524, email: candres1@cvm.fda.gov.

Regarding the draft guidance

documents: Thomas Letonja, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7576, e-mail: tletonja@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important

initiatives have been undertaken by

regulatory authorities and industry

associations to promote the

international harmonization of

regulatory requirements. FDA has

participated in efforts to enhance

harmonization and has expressed its

commitment to seek scientifically based

harmonized technical requirements for

the development of pharmaceutical

products. One of the goals of

harmonization is to identify and then

reduce the differences in technical

requirements for drug development

among regulatory agencies in different

countries.

FDA has actively participated in the

International Conference on

Harmonisation (ICH) of Technical

Requirements for Registration of

Pharmaceuticals for Human Use for

several years to develop harmonized

technical requirements for the approval

of human pharmaceutical and biological

products among the European Union,

Japan, and the United States. The VICH

is a parallel initiative for veterinary

medicinal products. The VICH is

concerned with developing harmonized

technical requirements for the approval

of veterinary medicinal products in the

62724 Federal Register / Vol. 65, No. 203 / Thursday, October 19, 2000 / Notices

European Union, Japan, and the United

States, and includes input from both

regulatory and industry representatives.

The VICH Steering Committee is

composed of member representatives

from the: European Commission;

European Medicines Evaluation Agency;

European Federation of Animal Health;

Committee on Veterinary Medicinal

Products; U.S. FDA; U.S. Department of

Agriculture; Animal Health Institute;

Japanese Veterinary Pharmaceutical

Association; Japanese Association of

Veterinary Biologics; and Japanese

Ministry of Agriculture, Forestry, and

Fisheries.

Two observers are eligible to

participate in the VICH Steering

Committee: One representative from the

Government of Australia/New Zealand

and one representative from the

industry in Australia/New Zealand. The

VICH Secretariat, which coordinates the

preparation of documentation, is

provided by the Confederation

Mondiale de L’Industrie de la Sante

Animale (COMISA). A COMISA

representative also participates in the

VICH Steering Committee meetings.

The VICH Steering Committee held a

meeting on November 16 through 19,

1999, and agreed that the three draft

guidances entitled ‘‘Effectiveness of

Anthelmintics: Specific

Recommendations for Equine’’ (VICH

GL15), ‘‘Effectiveness of Anthelmintics:

Specific Recommendations for Porcine’’

(VICH GL16), and ‘‘Effectiveness of

Anthelmintics: Specific

Recommendations for Canine’’ (VICH

GL19) should be made available for

public comment.

The three draft guidances: VICH

GL15, VICH GL16, and VICH GL19,

should be read in conjunction with the

‘‘Efficacy of Anthelmintics: General

Recommendations (EAGR)’’ announced

in the Federal Register of July 16, 1999

(64 FR 38445). The draft guidances for

equine, porcine, and canine are part of

the EAGR, and the aim of these three

draft guidances is to: (1) Be more

specific for certain issues not discussed

in the general guidance, (2) highlight

differences with the EAGR on

effectiveness data recommendations,

and (3) give explanations for disparities

with the EAGR. Comments about the

draft guidances will be considered by

the FDA and the VICH Anthelmintic

Working Group. Ultimately, FDA

intends to adopt the VICH Steering

Committee’s final guidances and

publish them as future guidances.

These draft guidances, developed

under the VICH process, have been

revised to conform to FDA’s good

guidance practices (65 FR 56468,

September 19, 2000). For example, the

documents have been designated

‘‘guidance’’ rather than ‘‘guideline.’’

Because guidance documents are not

binding, unless specifically supported

by statute or regulation, mandatory

words such as ‘‘must,’’ ‘‘shall,’’ and

‘‘will’’ in the original VICH documents

have been substituted with ‘‘should.’’

Similarly, words such as ‘‘requirement’’

or ‘‘acceptable’’ have been replaced by

‘‘recommendation’’ or ‘‘recommended’’

as appropriate to the context.

These draft guidances represent

current FDA thinking on effectiveness

recommendations for certain veterinary

anthelmintic medicinal products. These

draft guidances do not create or confer

any rights for or on any person and will

not operate to bind FDA or the public.

An alternate method may be used as

long as it satisfies the requirements of

applicable statutes and regulations.

II. Comments

These draft guidances are being

distributed for comment purposes only,

and they are not intended for

implementation at this time. Interested

persons may submit to the Dockets

Management Branch (address above)

written comments regarding the draft

guidance documents by December 18,

2000. 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 guidances

and received comments may be seen in

the Dockets Management Branch

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

through Friday.

Dated: October 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–26897 Filed 10–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–250 through

HCFA–254]

Notice of Emergency Clearance and

Public Meeting: Public Information

Collection Requirements Submitted to

the Office of Management and Budget

(OMB)

AGENCY: Health Care Financing

Administration, DHHS.

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, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this 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.

We are, however, requesting an

emergency review of the information

collections referenced below. In

compliance with the requirement of

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

Reduction Act of 1995, we have

submitted to the Office of Management

and Budget (OMB) the following

requirements for emergency review. We

are requesting an emergency review

because the collection of this

information is needed before the

expiration of the normal time limits

under OMB’s regulations at 5 CFR, Part

1320. A disruption in this collection

activity may cause public harm. This is

due to the potential and unnecessary

loss to the Medicare Trust Fund as the

result of the non-identification of health

insurance coverage that is primary to

Medicare. Collection of this information

allows HCFA to identify those Medicare

beneficiaries who have other group

health insurance that would pay before

Medicare, resulting in savings to the

Medicare Trust Fund. The annual

savings from the Medicare Secondary

Payer (MSP) program are more than $3

billion per year.

Emergency Clearance

HCFA is requesting OMB review and

approval of this collection by November

24, 2000, with a 180-day approval

period. Written comments and

recommendations will be accepted from

the public if received by the individuals

designated below by November 23,

2000. During this 180-day period, we

will publish a separate Federal Register

notice announcing the initiation of an

extensive 60-day agency review and

public comment period on these

requirements. We will submit the

requirements for OMB review and an

extension of this emergency approval.

Type of Information Request: Revision

of a currently approved collection; Title

of Information Collection: Medicare

Secondary Payer Information Collection