22586 Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices

availability of a draft guidance for

industry entitled ‘‘Providing Regulatory

Submissions in Electronic Format—

Postmarketing Expedited Safety

Reports.’’ This is one in a series of

guidance documents on providing

regulatory submissions to FDA in

electronic format. This specific

guidance discusses issues related to the

electronic submission of postmarketing

expedited safety reports for drug

products marketed for human use with

new drug applications (NDAs) and

abbreviated new drug applications

(ANDAs), prescription drug products

marketed for human use without an

approved NDA or ANDA, and

therapeutic biological products

marketed for human use with biologic

license applications (BLAs). This

guidance does not apply to vaccines.

The submission of these reports in an

electronic format will significantly

improve the agency’s efficiency in

processing, archiving, and reviewing the

reports.

DATES: Submit written comments on the

draft guidance by July 3, 2001. General

comments on agency guidance

documents are welcome at any time.

ADDRESSES: Submit written requests for

single copies of the draft guidance to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, or the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance

document.

FOR FURTHER INFORMATION CONTACT:

Deborah Yaplee, Center for Drug

Evaluation and Research (HFD–

400), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

3237, aersesub@cder.fda.gov; or

Michael Fauntleroy, Center for

Biologics Evaluation and Research

(HFM–588), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301–

827–5101, Fauntleroy@cber.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

FDA is announcing the availability of

a draft guidance for industry entitled

‘‘Providing Regulatory Submissions in

Electronic Format—Postmarketing

Expedited Safety Reports.’’ FDA has

cooperated with industry associations

and the regulatory authorities of certain

other nations to promote international

harmonization of regulatory

requirements. Much of this effort has

been coordinated through the

International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH).

Under the auspices of the ICH,

standards for electronic submission of

safety information for human drug and

biological products have been

developed, including a standard

medical terminology for regulatory

purposes, ICH M1; electronic standards

for the transfer of regulatory

information, ICH M2; and standardized

data elements for transmission of

individual case safety reports, ICH E2B

and E2BM formats.

This draft guidance is intended to

provide guidance to industry regarding

submission of postmarketing expedited

safety reports to FDA electronically

using the standards established by the

ICH. FDA believes the changes

recommended by the ICH will result in

more effective and efficient safety

reporting to regulatory authorities

worldwide.

This draft guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

draft guidance represents the agency’s

current thinking on providing

postmarketing expedited safety reports

in an electronic format. 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.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. 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. The draft

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

III. Paperwork Reduction Act of 1995

This notice contains no new

collections of information. The

information requested for marketed

human drug and biological products is

already covered by the collection of

information on postmarketing safety

reporting regulations (21 CFR 310.305,

314.80, and 600.80) submitted to the

Office of Management and Budget

(OMB) for review and clearance. This

notice merely provides applicants with

an alternative mechanism for submitting

postmarketing expedited safety reports

to the agency.

In accordance with the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520), OMB approved the information

collection for MedWatch—The FDA

Medical Products Reporting Program

(Forms FDA 3500 and FDA 3500A) and

assigned it OMB control number 0910–

0291. The approval for 0910–0291

expires on April 30, 2003.

OMB also approved the information

collection for adverse experience

reporting for marketed drugs and

licensed biological products and

assigned them OMB control numbers

0910–0230 and 0910–0308, respectively.

The approval for 0910–0230 expires on

May 31, 2002, and the approval for

0910–0308 expires on April 30, 2003.

IV. Electronic Access

Persons with access to the Internet

may obtain the document at http://

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

or at http://www.fda.gov/cber/

guidelines.htm.

Dated: April 27, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–11235 Filed 5–3–01; 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 the 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

Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices 22587

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 at (301) 443–1129.

Comments are invited on (a) whether

the agency needs to collect the proposed

information to properly perform its

functions and whether the information

has any practical utility; (b) whether the

agency’s estimate of the burden of the

proposed collection of information is

accurate; (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 for

respondents (e.g., by using automated

collection techniques or other forms of

information technology).

Proposed Project: Ryan White CARE

Act Dental Reimbursement Program

(OMB No. 0915–0151)—Revision

The Dental Reimbursement Program

(DRP) under Part F of the Ryan White

CARE Act offers grants to accredited

dental schools and programs that

provide non-reimbursed oral health care

to patients with HIV disease. The Ryan

White CARE Act Amendments of 2000

expanded eligibility of this program to

accredited schools of dental hygiene, in

addition to previously funded schools of

dentistry and post-doctoral dental

education programs.

HRSA requests a revision to the DRP

Application that schools and programs

use to apply for funding of nonreimbursed costs incurred in providing

oral health care to patients with HIV.

Awards are authorized under section

776(b) of the Public Health Service Act

(42 U.S.C. 294n). The 2001 DRP

Application is intended to collect data

in three different areas: program

information, patient demographics and

services, and reimbursement and

funding. It also requests applicants to

provide narrative descriptions of their

services and facilities, as well as their

links and collaboration with

community-based providers of oral

health services.

The primary purpose of collecting this

information annually, as part of the DRP

Application, is to verify eligibility and

determine the reimbursement amount

each applicant should receive. This

information also allows HRSA to learn

about (1) the extent of the involvement

of dental schools and programs in

treating patients with HIV, (2) the

number and characteristics of clients

who receive CARE Act-supported oral

health services, (3) the types and

frequency of the provision of these

services, (4) the non-reimbursed costs of

oral health care provided to patients

with HIV, and (5) how applicants intend

to use DRP funds once they are

received. In addition to meeting the goal

of accountability to Congress, clients,

advocacy groups, and the general

public, information collected in the DRP

Application is critical for HRSA, State

and local grantees, and individual

providers, to help assess the status of

existing HIV-related health service

delivery systems.

The reporting burden for reviewing

the DRP Application Instructions and

completing the Application Form is

estimated as:

Collection Number of

responsents

Hours per

application

Total burden hours

Reimbursement Request ......................................................................................................................... 125 20 2500

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: April 30, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–11236 Filed 5–3–01; 8:45 am]

BILLING CODE 4160–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases

(NIDDK): Opportunity for Cooperative

Research and Development

Agreements (CRADAs) To Perform

Intervention Studies To Preserve

Pancreatic Beta Cell Function and

Prevent Type 1 Diabetes

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institute of

Diabetes and Digestive and Kidney

Diseases (NIDDK) of the National

Institutes of Health (NIH) is seeking

proposals in the form of capability

statements from potential collaborators

for a Cooperative Research and

Development Agreement (CRADA) to

perform intervention studies to preserve

pancreatic beta cell function and

prevent type 1 diabetes. The clinical

research will execute pilot and

expanded studies of new agents to

prevent or ameliorate type 1 diabetes in

populations screened for or enrolled in

these studies.

Pursuant to the Federal Technology

Transfer Act of 1986 (FTTA, 15 U.S.C.

3710; and Executive Order 12591 of

April 10, 1987, as amended by the

National Technology Transfer and

Advancement Act of 1995), the National

Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK) of the

National Institutes of Health (NIH) of

the Public Health Service (PHS) of the

Department of Health and Human

Services (DHHS) seeks a Cooperative

Research and Development Agreement

(CRADA) with a pharmaceutical or

biotechnology company to perform

intervention studies to preserve

pancreatic beta cell function and

prevent type 1 diabetes.

The potential Collaborator(s)

capability statement should provide

proof of expertise in the design and

implementation of new intervention

studies of Type 1 Diabetes and should

include the scientific rationale for the

study proposed, the population to be

studied, eligibility and exclusion

criteria for the study, possible strategies

for patient recruitment and data

collection methods, primary and

secondary endpoints to be determined,

and a discussion of the sample size

required given associated assumptions.

The scientific rationale should include

a discussion of what is the current

‘‘state-of-the-art’’, future opportunities,

and obstacles in the prevention of type

1 diabetes, and discuss how the field

may best be moved forward.

DATES: Only written CRADA capability

statements received by the NIDDK on or

before July 1, 2001 will be considered;

confidential information must be clearly

labeled. Potential Collaborators may be

invited to meet with the Selection

Committee at the Collaborator’s expense

to provide additional information. The

Institute may issue an additional notice

of CRADA opportunity. This notice is

directed toward companies with

resources to support collaborations.