Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Notices 9793

Wisconsin

Martha Kerner, Section Chief, State/Federal

Relations, Wisconsin Department of

Administration, 101 East Wilson Street—

6th Floor, P.O. Box 7868, Madison,

Wisconsin 53707, Telephone: (608) 266–

2125, Fax: (608) 267–6931

Wyoming

Sheryl Jeffries, State Single Point of Contact,

Office of the Governor, State Capital, Room

124, Cheyenne, Wyoming 82002,

Telephone: (307) 777–5930, Fax: (307)

632–3909

Territories

Guam

Mr. Giovanni T. Sgambellluri, Director,

Bureau of Budget and Management

Research, Office of the Governor, P.O. Box

2950, Agana, Guam 96910, Telephone:

011–671–472–2285, Fax: 011–671–472–

2825

Puerto Rico

Norma Burgos/Jose E. Caro, Chairwoman/

Director, Puerto Rico Planning Board,

Federal Proposals Review Office, Minillas

Government Center, P.O. Box 41119, San

Juan, Puerto Rico 00940–1119, Telephone:

(809) 727–4444, (809) 723–6190, Fax: (809)

724–3270, (809) 724–3103

North Mariana Islands

Mr. Alvaro A. Santos, Executive Officer, State

Single Point of Contact, Office of

Management and Budget, Office of the

Governor, Saipan, MP, Telephone: (670)

664–2256, Fax: (670) 664–2272

Contact Person: Ms. Jacoba T. Seman, Federal

Programs Coordinator, Telephone: (670)

644–2289, Fax: (670) 644–2272

Virgin Islands

Jose George, Director, Office of Management

and Budget, #41 Norregade Emancipation

Garden Station, Second Floor, Saint

Thomas, Virgin Islands 00802

Please direct all questions and

correspondence about intergovernmental

review to: Linda Clarke, Telephone: (809)

774–0750, Fax: (809) 776–0069.

[FR Doc. 97–5300 Filed 3–3–97; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

[Docket No. 96N–0496]

Agency Information Collection

Activities: Proposed Collection;

Reinstatement

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 a notice in the Federal Register

concerning each proposed collection of

information, including each proposed

reinstatement of an existing collection

of information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the reporting and recordkeeping

requirements for manufacturers and

distributors of electronic products set

forth in the regulations.

DATES: Submit written comments on the

collection of information by April 3,

1997.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Judith V. Bigelow, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1479.

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.

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 reinstatement

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 listed below.

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 for Manufacturers and

Distributors of Electronic Products—21

CFR Parts 1002–1010, FDA Forms 2877,

3147, and 766 (OMB Control Number

0910–0025—Reinstatement)

Sections 532 through 542 (21 U.S.C.

360ii through ss) of the Federal Food,

Drug, and Cosmetic Act (the act) direct

the Secretary of the Department of

Health and Human Services (the

Secretary) to establish and carry out an

electronic product radiation control

program to protect the public from

unnecessary radiation from electronic

products. Such program shall include

the development, issuance, and

administration of performance

standards to control the emission of

electronic product radiation from

electronic 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 direct the

Secretary to immediately notify

manufacturers of, and assure correction

of, radiation defects or noncompliances

with performance standards. The

authority for records and reports is

contained in section 537(b) and (c) of

the act.

The regulations implementing these

statutory provisions are found in parts

1002 through 1010 (21 CFR parts 1002

through 1010). Section 1002.3 requires

manufacturers, when directed by FDA,

to provide technical and safety

information to users. Section 1002.10(a)

through (k) requires manufacturers to

submit to FDA product reports

containing identification, design,

operation and testing, quality control

procedures, test results, and product

labeling prior to the entry of the product

into commerce. Section 1002.11(a) and

(b) requires manufacturers to submit

supplemental reports to FDA if

modifications in product safety or

testing of electronic products affect

actual or potential radiation emission.

Section 1002.12(a) through (e) requires

manufacturers to submit abbreviated

information on product safety and

testing. Section 1002.13(a) through (c)

requires manufacturers to report

annually to FDA a summary of

manufacturer records maintained in

accordance with § 1002.30, and provide

quarterly updates of models instead of

§ 1002.10 or § 1002.11 reports. Section

1002.20(a) through (c) requires

manufacturers to report to FDA the

circumstances, amount of exposure, and
9794 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Notices

remedial actions taken concerning any

accidental radiation occurrence

involving their electronic products. If a

firm is also required to report the

incident under 21 CFR part 803, those

regulations take precedence. Section

1002.30(a) and (b) requires

manufacturers to keep records on test

data and procedures, correspondence

regarding radiation safety, and

distribution records. Section 1002.31(a)

requires manufacturers to maintain

records required to be kept under part

1002 for 5 years. Section 1002.31(c)

requires manufacturers, when requested

by FDA, to provide copies of the

distribution records required to be

maintained by § 1002.30(b). Section

1002.40(a) through (c) requires dealers

and distributors to retain first purchaser

information, to be used by

manufacturers when a product recall is

instituted to ensure the radiation safety

of a product. Section 1002.41(a) and (b)

specifies that the dealer/distributor

records in § 1002.40 may be retained by

the dealer or forwarded to the

manufacturer for retention and that the

manufacturer or dealer shall retain

distribution records for 5 years. Section

1002.50(a) specifies criteria by which

manufacturers may request exemption

from reporting and recordkeeping

requirements when there is a low risk of

injury, and § 1002.51 specifies criteria

by which manufacturers may request

exemption from reporting and

recordkeeping requirements under

certain circumstances if the product is

intended for U.S. Government use. The

burden is combined with § 1002.50(a),

because the processes and procedures

are identical.

Section 1003.10(a) and (c) requires

manufacturers to notify FDA when their

product has a defect or fails to comply

with applicable performance standards.

Also, under § 1003.10(b) manufacturers

must notify purchasers, dealers, and

distributors of product defects or

noncompliance. Section 1003.11(a)(3)

specifies criteria by which

manufacturers may refute FDA’s notice

of defective or noncompliant product,

and § 1003.11(b) states that

manufacturers, when notified by FDA,

must provide information on the

number of defective products

introduced into commerce. Section

1003.20(a) through (h) specifies

information to be provided by

manufacturers to FDA when the

manufacturer discovers a defect or

failure to comply. Section 1003.21(a)

through (d) specifies the content and

format of the notification by

manufacturers to affected persons

required by § 1003.10(a). Under

§ 1003.22(a) and (b), manufacturers

must provide to FDA copies of the

§ 1003.10 disclosure sent to purchasers,

dealers or distributors. Section

1003.30(a) and (b) specifies criteria by

which manufacturers may request an

exemption from the § 1003.10 disclosure

and possible product recall and

§ 1003.31(a) and (b) specifies the

content of the § 1003.30 report and the

procedure that the agency will follow in

reviewing exemption requests. Sections

1004.2(a) through (i), 1004.3(a) through

(i), and 1004.4(a) through (h) require

manufacturers to report to FDA every

plan to remedy a product defect or

noncompliance through repair or

replacement or refund.

Section 1005.21(a) through (c)

specifies criteria for manufacturers or

importers to request correction of

noncompliant products for importation

into the United States, including

specific corrections, timeframe, and

location for completion. Such requests

are made on Form FDA 766,

Application for Authorization to Relabel

or to perform other action of the Federal

Food, Drug, and Cosmetic Act and other

related Acts. Section 1005.25(a) and (b)

requires importers to report

identification information and

compliance status of products to FDA.

Initial designations are provided in the

§§ 1002.10, 1002.11, and 1002.12

reports, so that burden is included in

those sections. For each shipment,

identification is made on Form FDA

2877. Form FDA 2877, Declaration for

Products Subject to Radiation Control

Standards, is used to collect this

information.

Part 1010 prescribes performance

standards for electronic products, under

section 534 of the act, to which

manufacturers must certify. Section

1010.2(d) specifies criteria for

manufacturers to request alternate

means of certification to a performance

standard. Section 1010.3(a) through (c)

requires manufacturers to provide to

FDA the coding systems if information

on labels is coded and to identify each

brand name, and the name and address

of the individual or company for whom

each product so branded is

manufactured. Because firms provide

such information in the §§ 1002.10,

1002.11, and 1002.12 reports, the

burden is included in those sections.

Section 1010.4(b) specifies criteria for

manufacturers to petition FDA for a

variance from a performance standard.

Form FDA 3147, Application for a

Variance from 21 CFR 1040.11(c) for

Laser Light Shows, is used only by

manufacturers of laser products to

submit the information. Since the vast

majority of variances are submitted by

this industry, this form was developed

to reduce the burden and timeframe for

approvals. Section 1010.5(c) and (d)

specifies criteria by which

manufacturers or U.S. Government

agencies may request an exemption (or

amendment or extension) from

performance standards when a product

is to be used exclusively by a part of the

U.S. Government and has adequate

radiation emission specifications.

Section 1010.13 provides that

manufacturers may request alternate test

procedures from those specified in a

performance standard. The burden is

combined with § 1010.5(c) and (d)

because the processes and procedures

are identical.

The information collections are

placed upon manufacturers, importers,

assemblers, distributors and dealers of

electronic products. Not all of the

requirements are placed on all of these

groups. The data reported to FDA and

the records that are 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. The

reports are reviewed by FDA staff to

determine product safety and adequacy

of quality control testing. Potential and

actual problems are resolved with the

individual firm. Each firm’s quality

control staff reviews the test records to

maintain production of safe and

compliant products. The data provided

to users and others are intended to

encourage actions to reduce or eliminate

radiation exposures.

If FDA did not collect this

information, FDA may not have

sufficient information to take

appropriate actions to protect the public

from unnecessary radiation hazards

presented by electronic products.

FDA estimates the burden of this

collection of information as follows:
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Notices 9795

ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section/Form NumberNo. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours Total Operating &Maintenance Costs

1002.3 10 1 10 12 120 $2,940

1002.10, 1010.3 540 1.6 850 24 20,400 $499,800

1002.11 1,000 1.5 1,500 0.5 750 $18,375

1002.12 150 1 150 5 750 $18,375

1002.13 Annual 900 1 900 26 23,400 $573,300

1002.13 Quarterly 250 2.4 600 0.5 300 $7,350

1002.20 40 1 40 2 80 $1,960

1002.50(a), 1002.51 10 1.5 15 1 15 $367.50

Form FDA 2877 600 32 19,200 0.2 3,840 $94,080

1010.2 1 1 1 5 5 $122.50

1010.4 and Form FDA 3147 53 2.1 115 0.5 58 $1,421

1010.4—Other 1 1 1 120 120 $2,940

1010.5, 1010.13 3 1 3 22 66 $1,617

Totals 1,760 23,385 49,904 $1,222,648

There are no capital costs associated with this collection.

ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours Total Operating &Maintenance Costs

1002.30, 1002.31(a) 1,150 1,655.5 1,903,825 198.7 228,505 $5,598,373

1002.40, 1002.41 2,950 49.2 145,140 2.4 7,080 $173,460

Totals 4,100 235,585

There are no capital costs associated with this collection.

These burden estimates are based on

comments from industry and interviews

with industry personnel.

Several requirements are not included

in the burden chart because they are

exempt under 5 CFR 1320.4. These

exempt requirements are: Sections

1002.31(c), 1003.10(a) and (c),

1003.10(b), 1003.11(a)(3), 1003.11(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). Other requirements are not

included because they constitute a

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)).

Dated: February 24, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–5211 Filed 3–3–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995 for

opportunity for public comment on

proposed data collection projects, the

Health Resources and Services

Administration (HRSA) will publish

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, 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: Grantee Reporting

Requirements for the Rural Health

Network Grant Program; New

The Rural Health Network Grant

Program is authorized by Section 330A

of the Public Health Service Act as

amended by the Health Centers

Consolidation Act of 1996 ( Public Law

104–229). The purpose of the program is

to assist in the development of vertically

integrated networks of health care

providers in rural communities.

Grantees will be working to change the

delivery system in their service areas

and will be using the federal funds to

develop network capabilities.

Grantees will be asked to submit

semiannual reports which provide

information on progress towards goals

and objectives of the network, progress

toward developing the governance and

organizational arrangements for the

network, specific network activities,

certain financial data related to the grant

budget, and health care services

provided by the network.

The information will be used to

evaluate progress on the grants, to

understand barriers to network

development in rural areas, to identify

grantees in need of technical assistance,

and to identify best practices in the

development of provider networks in

rural communities. The information will