Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices 59851

This total estimate of 609 total annual

burden hours is based on the 1998

survey administration, in which 9,643

potential respondents were contacted to

obtain 1,000 interviews.

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25701 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–1353]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Current

Good Manufacturing Practices and

Related Regulations for Blood and

Blood Components

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:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

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.

Current Good Manufacturing Practices

(CGMP) and Related Regulations for

Blood and Blood Components (OMB

Number 0910–0116)—Extension

Under the statutory requirements

contained in the Public Health Service

Act (42 U.S.C. 262), no blood, blood

component, or derivative may move in

interstate commerce unless: (1) It is

propagated or manufactured and

prepared at an establishment holding an

unsuspended and unrevoked license; (2)

the product complies with regulatory

standards designed to ensure safety,

purity, and potency; and (3) it bears a

label plainly marked with the product’s

proper name, manufacturer, and

expiration date. The CGMP and related

regulations implement FDA’s statutory

authority to ensure the safety, purity,

and potency of blood and blood

components. The information collection

requirements in the CGMP regulations

provide FDA with the necessary

information to perform its duty to

ensure the safety, purity, and potency of

blood and blood components. These

requirements establish accountability

and traceability in the processing and

handling of blood and blood

components and enable FDA to perform

meaningful inspections. The

recordkeeping requirements serve

preventative and remedial purposes.

The disclosure requirements identify

the various blood and blood

components and important properties of

the product, demonstrate that the CGMP

requirements have been met, and

facilitate the tracing of a product back

to its original source. The reporting

requirements inform FDA of any

deviations that occur and that may

require immediate corrective action.

Section 606.100(b) (21 CFR

606.100(b)) requires that written

standard operating procedures (SOP’s)

be maintained for the collection,

processing, compatibility testing,

storage, and distribution of blood and

blood components used for transfusion

and manufacturing purposes. Section

606.100(c) requires the review of all

pertinent records to a lot or unit of

blood prior to release of the lot or unit.

Any unexplained discrepancy or failure

of a lot or unit of final product to meet

any of its specifications must be

thoroughly investigated, and the

investigation, including conclusions

and followup, must be recorded. Section

606.110(a) (21 CFR 606.110(a)) requires

a physician to certify in writing that the

donor’s health permits plateletpheresis

or leukapheresis if a variance from

additional regulatory standards for a

specific product is used when obtaining

the product from a specific donor for a

specific recipient. Section 606.110(b)

requires establishments to request prior

Center for Biologics Evaluation and

Research (CBER) approval for

plasmapheresis of donors who do not

meet donor requirements. The

regulation in 21 CFR 606.151(e) requires

that records of expedited transfusions in

life-threatening emergencies be

maintained. So that all steps in the

collection, processing, compatibility

testing, storage and distribution, quality

control, and transfusion reaction reports

and complaints for each unit of blood

and blood components can be clearly

traced, 21 CFR 606.160 requires that

legible and indelible contemporaneous

records of each significant step be made

and maintained for no less than 5 years.

The regulations in 21 CFR 606.165

require that distribution and receipt

records be maintained to facilitate

recalls, if necessary. Section 606.170(a)

(21 CFR 606.170(a)) requires records to

be maintained of any reports of

complaints of adverse reactions as a

result of blood collection or transfusion.

Each such report must be thoroughly

investigated, and a written report,

including conclusions and followup,

must be prepared and maintained.

Section 606.170(b) requires that fatal

complications of blood collections and

transfusions be reported to FDA as soon

as possible and that a written report

shall be submitted within 7 days.

In addition to the CGMP’s in part 606

(21 CFR part 606), there are regulations

in part 640 (21 CFR part 640) that

require additional standards for blood

and blood components as follows:

Sections 640.2(f); 640.3(a); 640.4(a);

640.25(b)(4) and (c)(1); 640.27(b);

640.31(b); 640.33(b); 640.51(b);

640.53(c); 640.56(b) and (d); 640.61;

640.63(b)(3), (e)(1), and (e)(3);

640.65(b)(2); 640.66; 640.71(b)(1);

640.72, 640.73; and 640.76(a) and (b).

The information collection requirements

and estimated burdens for these

regulations are included in the part 606

burden estimates, as described below.

Respondents to this collection of

information are licensed and unlicensed

blood establishments inspected by FDA,

and other transfusion services inspected

by the Health Care Financing

Administration (HCFA). Based on FDA’s

registration system, there are an

estimated 3,032 registered blood

establishments inspected by FDA of

which 1,349 perform pheresis. Based on

information provided by HCFA, there

are an estimated 3,400 transfusion

services inspected by HCFA. An

estimated 27 million units of whole

blood and blood components are

collected annually. The recordkeeping

chart reflects the estimate that 95

percent of the recordkeepers, which

collect 98 percent of the blood supply,

had developed SOP’s as part of their

customary and usual business practice.

Establishments may minimize burdens

associated with the CGMP and related

regulations by using model SOP’s

developed by industries’ accreditation

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