42560 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

Finally, the comment stated that

FDA’s reporting burden estimate is too

low because successful telephone

contact typically requires multiple

attempts. FDA disagrees with this

comment for two reasons: First, the

burden of making multiple attempts to

contact a potential survey respondent

will fall on FDA, not on the potential

respondent. Second, the burden

estimate already includes time to be

spent by respondents to set up a

subsequent interview.

FDA estimates the burden of this

survey as follows:

ESTIMATED ANNUAL REPORTING BURDEN

Burden Element No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Part 1—Computer Assisted Telephone Interview

(CATI)

Respond to initial recruitment telephone call 1,231 1 1,231 0.2 246.2

Receive and read introductory letter, key term

definitions 1,231 1 1,231 0.25 307.75

Obtain data to prepare for the telephone interview 1,231 1 1,231 0.35 430.85

Respond to telephone interview 1,231 1 1,231 0.5 615.50

Totals 1 1,600.3

Part 2—Onsite Cost Interview

Receive initial recruitment telephone call 17 1 17 0.2 3.4

Receive and read introductory letter and materials 17 1 17 0.25 4.25

Obtain data to prepare for the site visit 17 1 17 0.5 8.5

Respond to questions during site visit 17 1 17 3.0 51.0

Followup questions 17 1 17 0.25 4.25

Total burden hours, onsite interviews 71.4

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

The total burden hours for Part 1—

CATI and Part 2—Onsite Cost Interview

are 1,671.7.

The burden hour estimates are based

on a pretest conducted with three focus

groups.

Dated: July 30, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20754 Filed 8–6–97; 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; 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 September

8, 1997.

ADDRESSES: Submit written comments

on the collection of information to the

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. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, 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.

Interstate Shellfish Dealers

Certificate—(OMB Control Number

0910– 0021)—Reinstatement

Under 42 U.S.C. 243, FDA is required

to cooperate with and aid State and

local authorities in the enforcement of

their health regulations and is

authorized to assist States in the

prevention and suppression of

communicable diseases. Under this

authority, FDA participates with State

regulatory agencies, some foreign

nations, and the molluscan shellfish

industry in the National Shellfish

Sanitation Program (NSSP). The NSSP is

a voluntary, cooperative program to

promote the safety of molluscan

shellfish by providing for the

classification and patrol of shellfish

growing waters and for the inspection

and certification of shellfish processors.

Each participating State and foreign

nation monitors its molluscan shellfish

processors and issues certificates for

those that meet the State or foreign

shellfish control authority’s criteria.

Each participating State and nation

provides a certificate of its certified

shellfish processors to FDA on Form

FDA 3038, ‘‘Interstate Shellfish Dealer’s

Certificate.’’ FDA uses this information

to publish the ‘‘Interstate Certified

Shellfish Shippers List,’’ a monthly

comprehensive listing of all molluscan

shellfish processors certified under the

cooperative program. If FDA did not

collect the information necessary to

compile this list, participating States

would not be able to identify and keep

out shellfish processed by uncertified

processors in other States and foreign

nations. Consequently, the NSSP would

not be able to control the distribution of

uncertified and possibly unsafe shellfish

in interstate commerce, and its

effectiveness would be nullified.
Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42561

ESTIMATED ANNUAL REPORTING BURDEN

Form No. No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

FDA 3038 33 70 2,310 .10 231

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

This estimate is based on the number

of certificates received in 1996.

Dated: July 31, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20868 Filed 8–6–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0143]

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

‘‘Citizen Petition’’ 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. Wolff, 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 April 28, 1997 (62

FR 22959), 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). OMB has now

approved the information collection and

has assigned OMB control number

0910–0183. The approval expires on

June 30, 2000. 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.

Dated: July 31, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20869 Filed 8–6–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0323]

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 September

8, 1997.

ADDRESSES: Submit written comments

on the collection of information to the

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:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane, rm.

16B–19, Rockville, MD 20857, 301–827–

4659.

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.

Notice of Participation—(21 CFR 12.45)

(OMB Control Number 0910–0191—

Reinstatement)

Under part 12 (21 CFR part 12)

regulations issued under sections 201–

903 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321–393), any

interested person may participate in a

formal evidentiary hearing, either

personally or through a representative

by filing a notice of participation under

§ 12.45. Section 12.45 requires that any

person filing a notice of participation

state the person’s specific interest in the

proceedings, including the specific

issues of fact about which the person

desires to be heard. This section also

requires that the notice include a

statement that the person will present

documentary evidence on testimony at

the hearing and will comply with

specific requirements in § 12.85 or, in

the case of a hearing before a Public

Board of Inquiry, in 21 CFR 13.25,

concerning disclosure of data and

information by participants. A

participant’s appearance can be struck

by the presiding officer in accordance

with § 12.45(e).

The information obtained is used by

the presiding officer and other

participants in a hearing to identify

specific interests to be presented. This

preliminary information serves to

expedite the prehearing conference and

commits participation.

The affected respondents are

individuals or households, State or local

governments, not-for-profit institutions

and businesses or other for-profit groups

and institutions.

FDA estimates the burden of this

collection of information as follows:

ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

12.45 92 1 92 3 276

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