35648 Federal Register / Vol. 65, No. 108 / Monday, June 5, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Disease, Disability, and Injury

Prevention and Control Special

Emphasis Panel (SEP): Incidence of

Needlestick and Sharps Injuries and

Medical Safety Device Availability/Use

Among Non-Hospital Health Care

Workers, RFA–OH–00–004

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following meeting.

Name: Disease, Disability, and Injury

Prevention and Control Special Emphasis

Panel (SEP): Incidence of Needlestick and

Sharps Injuries and Medical Safety Device

Availability/Use Among Non-Hospital Health

Care Workers, RFA–OH–00–004.

Times and Date: 8 a.m.–8:30 a.m., July 25,

2000 (Open); 8:30 a.m.–4:30 p.m., July 25,

2000 (Closed).

Place: Embassy Suites, 1900 Diagonal

Road, Alexandria, Virginia 22314.

Status: Portions of the meeting will be

closed to the public in accordance with

provisions set forth in section 552b(c)(4) and

(6), Title 5 U.S.C., and the Determination of

the Associate Director for Management and

Operations, CDC, pursuant to Public Law 92–

463.

Matters to be Discussed: The meeting will

include the review, discussion, and

evaluation of applications received in

response to RFA–OH–00–004

Contact Person for More Information: Price

Connor, Ph.D., National Institute for

Occupational Safety and Health, CDC, 1600

Clifton Road, NE., m/s D30 Atlanta, Georgia

30333. Telephone 404/639–2383, e-mail

spc3@cdc.gov.

The Director, Management Analysis and

Services office has been delegated the

authority to sign Federal Register notices

pertaining to announcements of meetings and

other committee management activities, for

both the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: May 30, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention CDC.

[FR Doc. 00–13940 Filed 6–2–00; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Disease, Disability, and Injury

Prevention and Control Special

Emphasis Panel (SEP): Effects of

Mixed Dusts on Pulmonary

Inflammation, Airway Reactivity and

Susceptibility to Pulmonary Infection,

RFA# OH–00–009

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following meeting.

Name: Disease, Disability, and Injury

Prevention and Control Special Emphasis

Panel (SEP): Effects of Mixed Dusts on

Pulmonary Inflammation, Airway Reactivity

and Susceptibility to Pulmonary Infection,

RFA# OH–00–009.

Times and Date: 8 a.m.–8:30 a.m., July 26,

2000 (Open); 8:30 a.m.–5 p.m., July 26, 2000

(Closed).

Place: Embassy Suites, 1900 Diagonal

Road, Alexandria, Virginia 22314.

Status: Portions of the meeting will be

closed to the public in accordance with

provisions set forth in section 552b(c)(4) and

(6), Title 5 U.S.C., and the Determination of

the Associate Director for Management and

Operations, CDC, pursuant to Public Law 92–

463.

Matters to be Discussed: The meeting will

include the review, discussion, and

evaluation of applications received in

response to RFA–OH–00–009.

Contact Person for More Information:

Michael J. Galvin, Jr., Ph.D., Health Science

Administrator, Centers for Disease Control

and Prevention, National Institute for

Occupational Safety and Health, 1600 Clifton

Road, NE., m/s D30 Atlanta, Georgia 30333.

Telephone 404/639–3525, e-mail

mtg3@cdc.gov.

The Director, Management Analysis and

Services office has been delegated the

authority to sign Federal Register notices

pertaining to announcements of meetings and

other committee management activities, for

both the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: May 30, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention CDC.

[FR Doc. 00–13941 Filed 6–2–00; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1283]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Reporting and

Recordkeeping Requirements and

Availability of Sample Electronic

Products for Manufacturers and

Distributors of Electronic Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

information collection requirements for

reporting and recordkeeping, general

and specific requirements, and the

availability of sample electronic

products for manufacturers and

distributors of electronic products.

DATES: Submit written comments on the

collection of information by August 4,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

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: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Federal Register / Vol. 65, No. 108 / Monday, June 5, 2000 / Notices 35649

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Reporting and Recordkeeping

Requirements and Availability of

Sample Electronic Products for

Manufacturers and Distributors of

Electronic Products; 21 CFR Parts 1002,

1010, 1020, 1030, 1040, and 1050; FDA

Forms 2579, 2767, 2877, and 3147

(OMB Control No. 0910–0025)—

Extension

Under sections 532 through 542 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360ii through ss),

FDA has the responsibility to protect the

public from unnecessary exposure from

radiation from electronic products. The

regulations issued under these

authorities are listed in the Code of

Federal Regulations, title 21, chapter I,

subchapter J. Specifically, subchapter A

regulations, 21 CFR 5.10(a)(3), 5.25(b),

5.35(a)(1), and 5.86 through 5.92,

delegate administrative authorities to

FDA.

Section 532 of the act directs the

Secretary of the Department of Health

and Human Services (the Secretary) to

establish and carry out an electronic

product radiation control program,

including the development, issuance,

and administration of performance

standards to control the emission of

electronic product radiation from

electronic products. The program is

designed to protect the public health

and safety from electronic radiation, and

the act authorizes the Secretary to

procure (by negotiation or otherwise)

electronic products for research and

testing purposes and to sell or otherwise

dispose of such products.

Section 534(g) of the act directs the

Secretary to review and evaluate

industry testing programs on a

continuing basis; and section 535(e) and

(f) of the act directs the Secretary to

immediately notify manufacturers of,

and ensure correction of, radiation

defects or noncompliances with

performance standards.

Section 537(b) of the act contains the

authority to establish and maintain

records (including testing records),

make reports, and provide information

to determine whether the manufacturer

has acted in compliance.

Parts 1002 through 1010 (21 CFR parts

1002 through 1010) specify reports to be

provided by manufacturers and

distributors to FDA and records to be

maintained in the event of an

investigation of a safety concern or a

product recall.

FDA conducts laboratory compliance

testing of products covered by

regulations for product standards in

parts 1020, 1030, 1040, and 1050 (21

CFR parts 1020, 1030, 1040, and 1050).

FDA details product-specific

performance standards that specify

information to be supplied with the

product or require specific reports. The

information collections are either

specifically called for in the act or were

developed to aid the agency in

performing its obligations under the act.

The data reported to FDA and the

records maintained are used by FDA

and the industry to make decisions and

take actions that protect the public from

radiation hazards presented by

electronic products. This information

refers to the identification of, location

of, operational characteristics of, quality

assurance programs for, and problem

identification and correction of

electronic products. The data provided

to users and others are intended to

encourage actions to reduce or eliminate

radiation exposures.

FDA uses the following forms to aid

respondents in the submission of

information for this information

collection: (1) Form FDA 2767, ‘‘Notice

of Availability of Sample Electronic

Product,’’ (2) Form FDA 2877,

‘‘Declaration for Imported Electronic

Products Subject to Radiation Control

Standards,’’ and (3) Form FDA 3147,

‘‘Application for a Variance From 21

CFR 1040.11(c) for a Laser Light Show,

Display, or Device.’’

The most likely respondents to this

information collection will be electronic

product and x-ray manufacturers,

importers, and assemblers.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form No. No. of

Respondents;

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

1002.3 10 1 10 12 120

1002.10 and 1010.3 540 1.6 850 24 20,400

1002.11 1,000 1.5 1,500 0.5 750

1002.12 150 1 150 5 750

1002.13 (Annual) 900 1 900 26 23,400

1002.13 (Quarterly) 250 2.4 600 0.5 300

1002.20 40 1 40 2 80

1002.50(a) and 1002.51 10 1.5 15 1 15

FDA 2877 600 32 19,200 0.2 3,840

1010.2 1 1 1 5 5

1010.4(b) 1 1 1 120 120

1010.5 and 1010.13 3 1 3 22 66

FDA 2767 145 11.03 1,600 0.09 144

1020.20(c)(4) 1 1 1 1 1

1020.30(d), (d)(1), and

(d)(2) FDA 2579 2,345 8.96 21,000 0.30 6,300

1020.30(g) 200 1.33 265 35 9,275

35650 Federal Register / Vol. 65, No. 108 / Monday, June 5, 2000 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

21 CFR Section Form No. No. of

Respondents;

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

1020.30(h)(1) through

(h)(4) and 1020.32(a)(1)

and (g) 200 1.33 265 35 9,275

1020.32(g) and

1020.33(c), (d), (g)(4),

(j)(1), and (j)(2) 9 1 9 40 360

1020.40(c)(9)(i) and

(c)(9)(ii) 8 1 8 40 320

1030.10(c)(4) 41 1.61 66 20 1,320

1030.10(c)(5)(i) through

(c)(5)(iv) 41 1.61 66 20 1,320

1030.10(c)(6)(iii) and

(c)(6)(iv) 1 1 1 1 1

1040.10(a)(3)(i) 83 1 83 3 249

1040.10(h)(1)(i) through

(h)(1)(vi) 805 1 805 8 6,440

1040.10(h)(2)(i) and

(h)(2)(ii) 100 1 100 8 800

1040.11(a)(2) 190 1 190 10 1,900

1040.11(c) FDA 3147 53 2.2 115 0.5 58

1040.20(d), (e)(1), and

(e)(2) 110 1 110 10 1,100

1040.30(c)(1) 1 1 1 1 1

1040.30(c)(2) 7 1 7 1 7

1050.10(f)(1) through

(f)(2)(iii) 10 1 10 56 560

Total 89,278

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

1002.30 and 1002.31(a) 1,150 1,655.5 1,903,825 198.7 228,505

1002.40 and 1002.41 2,950 49.2 145,140 2.4 7,080

1020.30(g)(2) 22 1 22 0.5 11

1040.10(a)(3)(ii) 83 1 83 1.0 83

Total 235,679

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

The burden estimates were derived by

consultation with FDA and industry

personnel and actual data collected

from industry over the past 3 years. An

evaluation of the type and scope of

information requested was also used to

derive some time estimates. For

example, disclosure information

primarily requires time only to update

and maintain existing manuals. Initial

development of manuals has been

performed except for new firms entering

the industry. When information is

generally provided to users, assemblers,

or dealers in the same manual, they

have been grouped together in the

‘‘Estimated Annual Reporting Burden’’

table.

The following information collection

requirements are not subject to review

by OMB because they do not constitute

a ‘‘collection of information’’ under the

PRA: Sections 1002.31(c); 1003.10(a),

(b), and (c); 1003.11(a)(3) and (b);

1003.20(a) through (h); 1003.21(a)

through (d); 1003.22(a) and (b);

1003.30(a) and (b); 1003.31(a) and (b);

1004.2(a) through (i); 1004.3(a) through

(i); 1004.4(a) through (h); and 1005.21(a)

through (c). These requirements ‘‘apply

to the collection of information during

the conduct of general investigations or

audits’’ (5 CFR 1320.4(b)). The following

labeling requirements are also not

subject to review under the PRA

because they are a public disclosure of

information originally supplied by the

Federal Government to the recipient for

the purpose of disclosure to the public

(5 CFR 1320.3(c)(2)): Sections

1020.10(c)(4), 1030.10(c)(6), 1040.10(g),

1040.30(c)(1), and 1050.10(d)(1).

Dated: May 26, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–13892 Filed 6–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–0529]

Agency Information Collection

Activities; Announcement of OMB

Approval; Changes to an Approved

NDA or ANDA

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.