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.
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 / Notices 33935

FOR FURTHER INFORMATION CONTACT:

Aydin O ̈ rstan, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3076.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 721(d)(1) (21 U.S.C. 379e(d)(1))),

notice is given that a color additive

petition (CAP 8C0257) has been filed by

EM Industries, Inc., 7 Skyline Dr.,

Hawthorne, NY 10532. The petition

proposes to amend the color additive

regulations 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.

The agency has determined under 21

CFR 25.32(r) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: June 10, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–16504 Filed 6–19–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food And Drug Administration

[Docket No. 98F–0432]

Ticona; Filing of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Ticona has filed a petition

proposing that the food additive

regulations be amended to provide for

the safe use of chromium oxide green,

Cr2O3 (C.I. Pigment Green 17) as a

colorant for polymers intended for use

in contact with food.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8B4603) has been filed by

Ticona, c/o Keller and Heckman, 1001

G St. NW., suite 500 West, Washington,

DC 20001. The petition proposes to

amend the food additive regulations to

provide for the safe use of chromium

oxide green, Cr2O3 (C.I. Pigment Green

17) as a colorant for polymers intended

for use in contact with food. The agency

has determined under 21 CFR 25.32(i)

that this action is of the type that does

not individually or cumulatively have a

significant effect on the human

environment. Therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

Dated: June 4, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–16505 Filed 6–19–98; 8:45 am]

BILLING CODE 4160–01–F

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 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, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA) will

publish periodic summaries of proposed

projects being developed for submission

to the Office of Management and Budget

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 the use of

automated collection techniques or

other forms of information technology.

Proposed Project: Application for NHSC

Recruitment and Retention Assistance

and Waiver of NHSC Site Bill—(in use

Without Approval)

The National Health Service Corps

(NHSC) of the HRSA’s Bureau of

Primary Health Care, assists

underserved communities through the

development, recruitment, and retention

of primary health care clinicians

dedicated to serving people in health

professional shortage areas.

The Application for NHSC

Recruitment and Retention Assistance

submitted by sites or clinicians requests

information on the practice site,

sponsoring agency, recruitment contact,

staffing levels, service users, site’s 5-

year infant mortality or low birth rate

averages, and next nearest site.

Assistance in completing the

application may be obtained through the

appropriate State Primary Care Offices,

State Primary Care Associations and

HRSA field offices. A form requesting a

waiver of the NHSC site bill for a

calendar year may be requested at the

same time. The information on the

application is used for determining

eligibility of sites and to verify the need

for NHSC providers. Sites must submit

applications annually or when they

need a provider. The request for a

waiver is used to suspend the

educational and loan repayment costs of

NHSC providers.

Estimates of annualized reporting

burden are as follows:

Type of report Number of

respondents

Hours per

response

Total burden hour

Application ................................................................................................................................................ 1,000 .75 750

Waiver ...................................................................................................................................................... 738 4 2,952

Total ............................................................................................................................................... 1,000 .................... 3,702