35650 Federal Register / Vol. 65, No. 108 / Monday, June 5, 2000 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

21 CFR Section Form No. 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) 200 1.33 265 35 9,275

1020.32(g) and

1020.33(c), (d), (g)(4),

(j)(1), and (j)(2) 9 1 9 40 360

1020.40(c)(9)(i) and

(c)(9)(ii) 8 1 8 40 320

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

1030.10(c)(5)(i) through

(c)(5)(iv) 41 1.61 66 20 1,320

1030.10(c)(6)(iii) and

(c)(6)(iv) 1 1 1 1 1

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

1040.10(h)(1)(i) through

(h)(1)(vi) 805 1 805 8 6,440

1040.10(h)(2)(i) and

(h)(2)(ii) 100 1 100 8 800

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

1040.11(c) FDA 3147 53 2.2 115 0.5 58

1040.20(d), (e)(1), and

(e)(2) 110 1 110 10 1,100

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

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

1050.10(f)(1) through

(f)(2)(iii) 10 1 10 56 560

Total 89,278

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

1002.30 and 1002.31(a) 1,150 1,655.5 1,903,825 198.7 228,505

1002.40 and 1002.41 2,950 49.2 145,140 2.4 7,080

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

1040.10(a)(3)(ii) 83 1 83 1.0 83

Total 235,679

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

The burden estimates were derived by

consultation with FDA and industry

personnel and actual data collected

from industry over the past 3 years. 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.

The following information collection

requirements are not subject to review

by OMB because they do not constitute

a ‘‘collection of information’’ under the

PRA: Sections 1002.31(c); 1003.10(a),

(b), and (c); 1003.11(a)(3) and (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). These requirements ‘‘apply

to the collection of information during

the conduct of general investigations or

audits’’ (5 CFR 1320.4(b)). The following

labeling requirements are also not

subject to review under the PRA

because they are a public 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)): Sections

1020.10(c)(4), 1030.10(c)(6), 1040.10(g),

1040.30(c)(1), and 1050.10(d)(1).

Dated: May 26, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–13892 Filed 6–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–0529]

Agency Information Collection

Activities; Announcement of OMB

Approval; Changes to an Approved

NDA or ANDA

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

Federal Register / Vol. 65, No. 108 / Monday, June 5, 2000 / Notices 35651

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Changes to an Approved NDA or

ANDA’’ has been approved by the Office

of Management and Budget (OMB)

under the Paperwork Reduction Act of

1995.

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 January 6, 2000 (65

FR 779), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under 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 0910–0431. The

approval expires on February 28, 2001.

A copy of the supporting statement for

this information collection is available

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: May 26, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–13891 Filed 6–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0725]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Interstate

Shellfish Dealers Certificate

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.

DATES: Submit written comments on the

collection of information by July 5,

2000.

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:

Peggy 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 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)—Extension

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.

In the Federal Register of March 7,

2000 (65 FR 12013), the agency

requested comments on the proposed

collections of information. No

significant comments were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Form No. No. of

respondents

Annual

frequency per

response

Total annual

responses

Hours per

response Total hours

FDA 3038 35 58 2,036 .10 204

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