66634 Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices

supplied by the Federal Government to

the recipient for the purpose of

disclosure to the public is not a

collection of information.

Dated: December 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33091 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0309]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the

collection of information by January 20,

1998.

ADDRESSES: Submit written comments

on the collection of information to

Office of Information and Regulatory

Affairs, OMB, New Executive Office

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

Washington, DC 20503, Attn: Desk

Officer for FDA.

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: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Infant Formula Requirements (21 CFR

106.100, 21 CFR 106.120(b), 21 CFR

107.10(a), 21 CFR 107.20, 21 CFR

107.50(e)(2), 21 CFR 107.50(b)(3), 21

CFR 107.50(b)(4), 21 CFR

107.50(c)(3))—(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 establish and adhere to

quality control procedures, notify FDA

when a batch of infant formula that has

left the manufacturer’s control may be

adulterated or misbranded, and keep

records of distribution. FDA has issued

regulations to implement the act’s

requirements for infant formula in 21

CFR parts 106 and 107.

FDA also regulates the labeling of

infant formula under the authority of

section 403 (21 U.S.C. 343). Under the

labeling regulations for infant formula

in 21 CFR 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 below. 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.

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

106.120(b) 4 7 28 0 0

107.10(a) 107.20 4 7 28 8 224

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

107.50(e)(2) 3 4 12 0 0

Total 272

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

106.100 4 10 40 4,000 16,000

107.50(c)(3) 4 10 40 0 0

Total 16,000

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. Because these infant

formula regulations implement statutory

information collection requirements,

only the additional burden attributable

to the regulations has been included in

the estimates.

Due to clerical error, the burden

estimates that appeared in FDA’s

previous notice soliciting comments on

this collection of information (62 FR

42256, August 6, 1997) were incorrect.

The tables above contain the correct

estimates.
Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices 66635

Dated: December 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33092 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Dental Products Panel of the Medical

Devices Advisory Committee; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Dental Products

Panel of the Medical Devices Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on January 12, 1998, 10:15 a.m. to

5 p.m., and January 13, 1998, 8 a.m. to

5 p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Pamela D. Scott,

Center for Devices and Radiological

Health (HFZ–480), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–827–5283, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12518. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On January 12, 1998, the

committee will discuss and vote on a

premarket approval application for a

bone filling and augmentation device for

periodontal use. On January 13, 1998,

the committee will discuss and make

recommendations to FDA regarding the

reclassification of subgroups of

endosseous dental implant devices. The

following subgroups of endosseous

implants will be included: Coated and

uncoated root form implants, coated and

uncoated blade-type implants,

temporary implants, and implants with

special enhanced retention features.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by December 29, 1997. Oral

presentations from the public will be

scheduled between approximately 10:30

a.m. and 11:30 a.m. on January 12, 1998,

and between approximately 8:10 a.m.

and 9:10 a.m. on January 13, 1998. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before January 5, 1998,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: December 12, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–33096 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0317]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled,

‘‘Interstate Shellfish Dealers

Certificate,’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 7, 1997 (62

FR 42560), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has approved the information

collection and has assigned OMB

control number 0910–0021. The

approval expires on September 30,

2000.

Dated: December 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33093 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 95N–0245 and 94P–0110]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Food Labeling; Statement of Identity,

Nutrition Labeling and Ingredient

Labeling of Dietary Supplements;

Compliance Policy Guide, Revocation’’

has been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(the PRA).

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: In the

Federal Register of September 23, 1997

(62 FR 49826), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0351. The

approval expires on November 30, 2000.

Dated: December 11, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33094 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F