59852 Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices

organizations. These accreditation

organizations represent almost all

registered blood establishments. The

total annual responses in the reporting

chart for fatality reporting are based on

an annual average of fatality reports

submitted to FDA. The annual

frequency of recordkeeping and total

annual records, and the estimated

reporting and recordkeeping burden

hours are based on information

provided by industry, and FDA’s

experience. Under § 606.110(b), licensed

establishments submit supplements to

their biologics license applications to

request prior CBER approval of

plasmapheresis donors who do not meet

donor requirements. The information

collection requirements for § 606.110(b)

are reported under OMB control number

0910–0315.

In the Federal Register of July 6,

2000 (65 FR 41674), the agency

requested comments on the proposed

collections of information. No

significant comments were received.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section2 No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

606.170(b) 75 1 75 20 1,500

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

2The reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b).

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section2 No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

606.100(b) 3223 1 322 24 7,728

606.100(c) 1524 26 4,000 1 4,000

606.110(a) 685 5 340 0.5 170

606.151(e) 3223 12 3,864 0.083 321

606.160 3223 1,677 540,000 0.5 270,000

606.165 1524 3,553 540,000 0.083 44,820

606.170(a) 3223 12 3,864 1 3,864

Total 330,903

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

2The recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOP’s, are included in the estimate for § 606.100(b); the recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for

plateletpheresis, are included in the estimate for § 606.110(a); and the recordkeeping requirements in §§ 640.2(f), 640.3(a)(2), 640.3(f),

640.4(a)(2), 640.25(b)(4) and (c)(1), 640.31(b), 640.33(b), 640.51(b), 640.53(c), 640.53(c), 640.56(b) and (d), 640.61, 640.63(b)(3), (e)(1), and

(e)(3), 640.65(b)(2), 640.71(b)(1), 640.72, and 640.76(a) and (b), which address the maintenance of various records, are included in the estimate

for § 606.160. 35 percent of HCFA and FDA-registered blood establishments (0.05 X (3,400+3,032))

45 percent of FDA-registered establishments (3,032)

55 percent of pheresis establishments (1,349)

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25698 Filed 10–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1395]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Medicated

Feed Mill License

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 November

6, 2000.

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, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In

compliance with section 44 U.S.C. 3507,

FDA has submitted the following

proposed collection of information to

OMB for review and clearance.

Medicated Feed Mill License 21 CFR

Part 515—(OMB Control Number 0910–

0337)—Extension

Description: This rule sets forth the

information to be included in a

medicated feed mill license application

and subsequent supplemental

applications. In addition, it provides

criteria for the approval and

nonapproval of a medicated feed mill

license application and the criteria for

the revocation and/or suspension of a

license. More specifically, § 515.10(b)

specifies requirements for submitting a

completed medicated feed mill license

application, using Form FDA 3448.

Section 515.11(b) specifies requirements

for supplemental medicated feed

applications for a change in ownership

and/or a change in mailing address for

the facility cite, using Form FDA 3448.

Section 515.23 sets forth written

requirements for voluntary revocation of

a medicated feed mill license by a

sponsor on the grounds that the facility

Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices 59853

no longer manufacture any animal feed.

Section 515.30(c) details requirements

for filing a request for a hearing by a

sponsor to give reasons why a

medicated feed mill license application

should not be refused or revoked and

§ 510.305(b) (21 CFR 510.305 (b)),

requires maintenance of approved

labeling for each Type B and/or Type C

medicated feed being manufactured on

the premises of the manufacturing

establishment or the facility where the

feed labels are generated.

Description of Respondents:

Respondents to this collection of

information are individuals or firms that

manufacture medicated animal feed. In

the Federal Register of July 26, 2000 (65

FR 45987), FDA published a 60-day

notice concerning the proposed

extension of this collection of

information and requested comments. In

response to this notice, no comments

were received on the estimated annual

reporting and recordkeeping burden. We

therefore believe that the total burden

estimate of 72 hours for the annual

reporting and recordkeeping burden

should remain unchanged.

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

515.10(b) 100 1 100 0.25 25

515.11(b) 25 1 25 0.25 6.25

515.23 50 1 50 0.25 12.25

515.30(c) 0.15 1 0.15 24 3.6

Total burden hours 47.10

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

510.305(b) 100 1 100 .25 25

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

The estimate for the number of

respondents is derived from agency

data, i.e. the number of medicated feed

manufacturers entering the market each

year, change in ownership or address,

requests for voluntary revocation of a

medicated feed mill license, revocation

and/or suspension of a license. The

estimate of the time required for the

reporting and recordkeeping

requirements is based on the agency

communication with industry.

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25699 Filed 10–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1309]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Suggested

Documentation for Demonstrating

Compliance With the Channels of

Trade Provision

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 November

6, 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: Wendy

Taylor, 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.

Suggested Documentation for

Demonstrating Compliance With the

Channels of Trade Provision

Description: Under the pesticide

tolerance reassessment process that the

Environmental Protection Agency (EPA)

was mandated to carry out under the

Food Quality Protection Act (FQPA),

EPA has proposed to revoke the

tolerances for the pesticide chemical

methyl parathion on several food

commodities. The FQPA includes a

provision in section 408(l)(5) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 346a(l)(5)), referred

to as the ‘‘channels of trade provision,’’

that addresses the circumstances under

which a food is not unsafe solely due to

the presence of a residue from a

pesticide chemical whose tolerance has

been revoked, suspended, or modified

by EPA. These circumstances are met if

the party responsible for the food can

demonstrate to FDA that the residue in

the food resulted from application of the

pesticide chemical to the food

commodity at a time and in a manner

that was lawful under the Federal

Insecticide Fungicide and Rodenticide

Act (FIFRA).

In general, FDA anticipates that the

party responsible for food found to

contain methyl parathion residues

(within the former tolerance) after the