65276 Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Notices

These estimates are based on FDA’s

Center for Drug Evaluation and

Research, Product Information

Management Branch, and its data and

information on drug listing and

establishment registration of

manufacturers, repackers, relabelers,

and other drug processors.

Dated: December 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32461 Filed 12–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0311]

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 following 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

this collection of information by January

12, 1998.

ADDRESSES: Submit written comments

on this 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,

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.

CGMP and Related Regulations for

Blood and Blood Components—(21 CFR

Parts 606 and 640)—(OMB Control

Number 0910–0116)—Reinstatement

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, its 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) 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) 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 606.151(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,

§ 606.160 requires that legible and

indelible contemporaneous records of

each significant step be made and

maintained for no less than 5 years.

Section 606.165 requires that

distribution and receipt records be

maintained to facilitate recalls, if

necessary. Section 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,

there are regulations in part 640 that

require additional standards for blood

and blood components: §§ 640.3(a) and

(f), 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.

The recordkeeping requirements for

§§ 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 for § 640.27(b), which

addresses the maintenance of donor

health records for plateletpheresis, is

included in the estimate for

§ 606.110(a); and the recordkeeping

requirements for §§ 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), 640.56(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.

The reporting requirement in § 640.73,

which addresses the reporting of fatal

donor reactions, is included in the

estimate for § 606.170(b).

Respondents to this collection of

information are registered blood

establishments. There are an estimated

3,021 FDA registered blood collection

facilities in the United States that

annually collect an estimated

23,500,000 units of whole blood and

source plasma. Of the 3,021 registered

establishments, 1,799 establishments

perform pheresis collections and 278

establishments perform transfusions.
Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Notices 65277

There are also an estimated 4,500 Health

Care Financing Administration

registered transfusion services. 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 normal business practice.

Establishments may minimize burdens

associated with the CGMP and related

regulations by using model SOP’s

developed by blood organizations.

These blood organizations represent

almost all of the registered

establishments.

FDA estimates the burden of this

information collection 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

606.170(b) 42 1 42 8 336

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

606.100(b) 151 1 151 24 3,624

606.100(c) 151 3.6 550 3.6 550

606.110(a) 90 5 450 2.5 225

606.151(e) 239 12 2,868 1 239

606.160 151 3,112 470,000 1,556 234,956

606.165 151 3,112 470,000 258 38,958

606.170(a) 376 12 4,512 12 4,512

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

Dated: December 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32458 Filed 12–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N–0453]

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 12,

1998.

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,

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.

Human Tissue Intended for

Transplantation (OMB Control Number

0910–0302)—Reinstatement

FDA issued final regulations in the

Federal Register of July 29, 1997 (62 FR

40429) to prevent the transmission of

human immunodeficiency virus (HIV),

hepatitis B, and hepatitis C through the

use of human tissue for transplantation.

The final regulations closely parallel

those contained in the interim rule on

human tissue intended for

transplantation. Both the interim and

final rule provide for inspection by FDA

of persons and tissue establishments

engaged in the recovery, screening,

testing, processing, storage, or

distribution of human tissue. These

facilities are required to meet standards

intended to ensure appropriate

screening and testing of human tissue

donors and ensure that records are kept

documenting that the appropriate

screening and testing have been

completed.

There are approximately 60 tissue

establishments with 300 employees that

are members of the American

Association of Tissue Banks. There are

an additional 600 individual members

of which 50 percent are performing a

tissue banking activity. The Eye Bank

Association of America’s membership

consists of 120 eye banks of which 110

are in the continental United States.

With the rare exceptions noted in the

preamble of the rule, FDA believes that

all respondents perform donor testing

and screening for HIV and hepatitis and

these regulations add no additional

requirements. 21 CFR 1270.31(c) and (d)

require written procedures for the

designation and identification of

quarantined tissue and to prevent the

contamination or cross-contamination of

tissue during processing. 21 CFR

1270.35(c) requires documentation of

the distribution and receipt of human

tissue, completing the accounting of

tissue between determination of

suitability, and the destruction or

disposition of the tissue.

When the interim rule was issued in

the Federal Register of December 14,

1993 (58 FR 65514), accredited members

of the American Association of Tissue

Banks and the Eye Bank Association of

America were already in compliance

with the regulations by adhering to the

standards established by these

organizations. The requirements in the