Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 / Notices 33933

Board of Governors of the Federal Reserve

System, June 17, 1998.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 98–16541 Filed 6–19–98; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0364]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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

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

product specific reports and

recordkeeping requirements for certain

electronic products.

DATES: Submit written comments on the

collection of information by August 21,

1998.

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:

Margaret R. 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.

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 for

Electronic Products: Specific Product

Requirements 21 CFR Parts 1020, 1030,

1040, and 1050 (OMB Control Number

0910–0213—Reinstatement)

Under sections 532 to 542 of the

Federal Food, Drug, and Cosmetic Act

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

has the responsibility to protect the

public from unnecessary exposure to

radiation from electronic products.

Section 532 of the act (21 U.S.C. 360ii)

directs the Secretary of the Department

of Health and Human Services (the

Secretary) to establish and carry out an

electronic product radiation control

program designed to protect the public

health and safety from electronic

radiation by, among other things,

developing and administering

performance standards for electronic

products. Section 534(g) of the act (21

U.S.C. 360kk(g)) directs the Secretary to

review and evaluate industry testing

programs on a continuing basis; and

section 535(e) and (f) of the act (21

U.S.C. 360ll(e) and (f)) directs the

Secretary to immediately notify

manufacturers of, and assure correction

of, radiation defects or noncompliance

with performance standards. The

agency’s authority to require records

and reports is contained in section

537(b) and (c) of the act (21 U.S.C.

360nn(b) and (c)).

Under this authority, FDA issued

regulations detailing 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 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. 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.

The consequence of not obtaining the

required information is that the public

unknowingly may be exposed to

unnecessary radiation hazards

presented by electronic products.

Without this information, FDA could

not adequately make rational decisions

and take appropriate actions to protect

the public from these hazards as called

for in the act.

Respondents to this collection of

information are manufacturers,

importers, and assemblers of electronic

products. Not all of the requirements are

placed on all of these groups.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

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

1020.30(g) 200 1.33 265 35 9,275
33934 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

21 CFR Section 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)2* 200 1.33 265 35 9,275

1020.32(g) and 1020.33(c), (d), (g)(4), (j)(1), and

(j)(2)2* 9 1.00 9 40 360

1020.40(c)(9)(i) and (c)(9)(ii) 8 1.00 8 40 320

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

1030.10(c)(5)(i) through (c)(5)(iv)2* 41 1.61 66 20 1,320

1040.10(h)(1)(i) through (h)(1)(iv) 805 1.00 805 8 6,440

1040.10(h)(2)(i) and (h)(2)(ii)2* 100 1.00 100 8 800

1040.11(a)(2)2* 190 1.00 190 10 1,900

1040.20(d)(1), (d)(2), (e)(1), and (e)(2) 110 1.00 110 10 1,100

1040.30(c)(1) 1 1.00 1 1 1

1050.10(f)(1) and (f)(2)(i) through (f)(2)(iii) 10 1.00 10 56 560

Disclosure Subtotal 1,176 1,896 32,672

1020.30(d)(1) and (d)(2) and Form FDA 2579 2,345 8.96 21,000 .30 6,300

1030.10(c)(6)(iii) and (c)(6)(iv) 1 1.00 1 1 1

1030.10(c)(6)(iv) 1 1.00 1 1 1

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

1040.10(i)—burden in 1002.10 (0910–0025) 0 0 0 0

Reports Subtotal 2,430 21,085 6,551

Total Annual Reporting Burden 3,606 6.37 22,981 1.71 39,223

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

2The total number of respondents in the reporting burden, Table 1, include respondents who have already been included as a subset of another group in the table. The number of firms marked by an asterisk have been included and counted as a subset of the total firms subject to reporting burden. Therefore, the number of firms represented by an asterisk have not been added to the total number of respondents on the entry

for ‘‘Disclosure Subtotal,’’ and are not included in the total listed on the last entry of the reporting burden table entitled ‘‘Total Annual Reporting

Burden.’’ However, any hours of burden generated by these firms were added to the total reporting burden hours on both the disclosure subtotal

and total lines of the reporting burden table.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

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

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

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

Total Annual Recordkeeping Burden 101

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

Certain labeling requirements

included in these regulations are either

exempt from the definition of

‘‘collection of information’’ under 5 CFR

1320.3(c)(2) because they are ‘‘public

disclosure[s] of information originally

supplied by the Federal Government to

the recipient for the purpose of

disclosure to the public’’ or have

negligible burden. For example, 21 CFR

1040.10(g) states that ‘‘in addition to the

requirements of §§ 1010.2 and 1010.3,

each laser product shall be subject to the

applicable labeling requirements of this

paragraph.’’ The provision goes on to

require several cautionary statements in

the labeling of laser products approved

under this regulation, and further

specifies the wording, placement and

label design of the required labeling.

21 CFR 1040.30(c)(1), 1050.10(d)(1)

through (d)(5), and 1020.10(c)(4) are

labeling requirements which are exempt

from OMB.

The burden hour and cost estimates

were derived by consultation with FDA

and industry personnel. 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 .

Dated: June 11, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16503 Filed 6–19–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98C–0431]

EM Industries, Inc.; Filing of Color

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that EM Industries, Inc., has filed a

petition proposing that the color

additive regulations be amended to

provide for the safe use of synthetic iron

oxide to color ingested drugs at levels

higher than the current limit and to

provide for the safe use of mica to color

ingested drugs.