67388 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices

the pilot protocols will be included in

the ClinicalTrials.gov data bank, the

estimated annual burden for the first

year will be reduced by the number of

protocols included in the pilot.

FDA estimates the burden of the

collection of information as follows:

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN 1

New Protocols Protocol

Changes

New

Investigators

Total Annual

Responses

Hours per

Response Total Hours

CDER 200 400 600 1,200 5.6 6,720

CBER 50 100 150 300 5.6 1,680

Total 8,400

1There are no capital and startup, or operation and maintenance costs associated with this collection of information.

Dated: November 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28851 Filed 11–8–00; 8:45 am]

BILLING CODE 4160–01–F /

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1441]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Infant

Formula Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by December

11, 2000.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Infant Formula Requirements (OMB

Control Number 0910–0256)—Extension

Statutory requirements for infant

formula under the Federal Food, Drug,

and Cosmetic Act (the act) are intended

to protect the health of infants and

include a number of reporting and

recordkeeping requirements. Among

other things, section 412 of the act (21

U.S.C. 350a) requires manufacturers of

infant formula to: (1) Establish and

adhere to quality control procedures, (2)

notify FDA when a batch of infant

formula that has left the manufacturers’

control may be adulterated or

misbranded, and (3) keep records of

distribution. FDA has issued regulations

to implement the act’s requirements for

infant formula in parts 106 and 107 (21

CFR parts 106 and 107). FDA also

regulates the labeling of infant formula

under the authority of section 403 of the

act (21 U.S.C. 343). Under the labeling

regulations for infant formula in part

107, the label of an infant formula must

include nutrient information and

directions for use. The purpose of these

labeling requirements is to ensure that

consumers have the information they

need to prepare and use infant formula

appropriately. In a document published

in the Federal Register of July 9, 1996

(61 FR 36154), FDA proposed changes

in the infant formula regulations,

including some of those listed in tables

1 and 2 of this document. The document

included revised burden estimates for

the proposed changes and solicited

public comment. In the interim,

however, FDA is seeking an extension of

OMB approval for the current

regulations so that it can continue to

collect information while the proposal

is pending.

In the Federal Register of August 18,

2000 (65 FR 50539), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Federal Food, Drug, and Cosmetic Act (the Act) or

21 CFR Section

No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Section 412(d) of the act 4 7 28 10 280

106.120(b) 4 0.25 1 4 4

107.10(a) and 107.20 4 7 28 8 224

107.50(b)(3) and (b)(4) 3 4 12 4 48

107.50(e)(2) 3 0.33 1 4 4

Total 560

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices 67389

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

106.100 4 10 40 4,000 16,000

107.50(c)(3) 3 10 30 3,000 9,000

Total 25,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

In compiling these estimates, FDA

consulted its records of the number of

infant formula submissions received in

the past. The figures for hours per

response are based on estimates from

experienced persons in the agency and

in industry.

Dated: November 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28852 Filed 11–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Radiological Health Reengineering;

Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public workshop.

The Food and Drug Administration

(FDA), Center for Devices and

Radiological Health (CDRH), is

announcing a public workshop intended

to gather information regarding its

radiological health programs. The topic

to be discussed is reengineering of

electronic product radiation control

processes with attention to

prioritization, information exchange on

new technology and public health

issues, standards, and product testing.

Date and Time: The public workshop

will be held on November 15 and 16,

2000, 8:30 a.m. to 4:30 p.m.

Location: The public workshop will

be held at the Holiday Inn, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact: Joanne Barron, Center for

Devices and Radiological Health (HFZ–

342), Food and Drug Administration,

2094 Gaither Rd., Rockville, MD 20850,

301–594–4654, FAX 301–594–4672, email: jxb@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION: At the

workshop, FDA would like to hear

whether certain radiological health

programs and processes would benefit

from changes and, if so, which changes

would be most effective. The purpose of

reengineering the radiological health

processes is to make the best use of FDA

expertise and resources in performing

activities that best fulfill FDA’s role in

radiation protection. While

reengineering provides opportunities to

shift priorities, FDA also would like to

establish partnerships with others who

have a role in radiation protection from

electronic products.

During the past 2 years, FDA obtained

comments from stakeholders on

improvements needed in the

radiological health program. Comments

received suggested four areas for

improvement: (1) Prioritization, (2)

information exchange, (3) standards,

and (4) product testing. Several FDA

teams considered the ideas and now

would like public participation in

revising the processes. CDRH must

prioritize the use of limited resources to

effectively and efficiently address these

public health concerns. To that end,

FDA issues recommendations and

guidance and develops and enforces

regulatory performance standards for

radiation-emitting electronic products to

minimize exposures to unnecessary

radiation. FDA develops test methods

and tests electronic products to ensure

conformance to standards, identify

nationwide exposure trends, and

provide a basis for analyzing new

technologies. FDA and stakeholders

need information on product emissions,

exposures, use, and health effects as a

basis for decisions and actions. CDRH

expects this public workshop to benefit

the radiological health reengineering

effort by developing practical solutions

to the following questions:

1. How should CDRH choose and

implement specific radiological health

activities and set priorities?

2. How can CDRH optimize and

improve the development/

administration of electronic product

radiation standards, recommendations,

and guidances?

3. How can CDRH optimize and

improve the evaluation of radiation

emissions and exposures from

electronic products?

4. How can CDRH better communicate

and network with partners (States, other

Federal agencies, industry, health

professionals, standards organizations,

etc.) regarding its radiological health

program?

FDA will conduct concurrent

breakout sessions on each of the four

topics during this public workshop.

Registration and Requests for Oral

Presentations: Send registration

information (including name, title, firm

name, address, telephone, fax number,

and e-mail address), and written

material and requests to make oral

presentations to Diarra Hall at Laurel

Consulting Group, 14504 Greenview Dr.,

suite 500, Laurel, MD 20708, 301–490–

5500, FAX 301–490–7260 by November

13, 2000; or complete the registration

form that is available at http://

www.fda.gov/cdrh/reenging/radhlth/

index.html.

If you need special accommodations

due to a disability, please contact Diarra

Hall in advance.

Transcripts: Transcripts of the public

workshop may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

public workshop at a cost of 10 cents

per page.

Dated: November 2, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–28694 Filed 11–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1562]

Draft Guidance for Industry on Cancer

Drug and Biological Products—Clinical

Data in Marketing Applications;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the