41674 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices

1. Annual progress reports;

2. Financial status report, no more

than 90 days after the end of the budget

period;

3. Final financial report and

performance reports, no more than 90

days after the end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–4 HIV/AIDS Confidentiality

Provisions

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 317(k) (2) of the Public Health

Service Act, 42 U.S.C. 247b(k)(2). The

Catalog of Federal Domestic Assistance

number is 93.941, HIV Demonstration,

Research, Public and Professional

Education Projects.

J. Where To Obtain Additional

Information

This and other CDC [ATSDR]

announcements can be found on the

CDC home page Internet: http://

www.cdc.gov. Click on ‘‘Funding’’, then

‘‘Grants and Cooperative Agreements.’’

To receive additional written

information and to request an

application kit, call 1–888–GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

Announcement number of interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Annie

H. Camacho, Grants Management

Specialist, Centers for Disease Control

and Prevention (CDC), Procurement and

Grants Office, Room 3000, 2920

Brandywine Road, Mailstop E–15,

Atlanta, GA 30341–4146, Telephone:

(770) 488–2735, Email: atc4@cdc.gov.

For program technical assistance,

contact: Leo Weakland, Deputy

Coordinator, Global AIDS Activity

(GAA), National Center for HIV, STD,

and TB Prevention, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, Mailstop E–07, Atlanta,

GA 30333, Telephone number (404)

639–8016, Email address: lfw0@cdc.gov.

Dated: June 29, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control (CDC).

[FR Doc. 00–17011 Filed 7–5–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1353]

Agency Information Collection

Activities; Proposed Collection;

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 an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the information collection requirement

relating to the regulation of FDA’s

current good manufacturing practice

(CGMP) and related regulations for

blood and blood components.

DATES: Submit written comments on the

collection of information by September

5, 2000.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

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: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

when appropriate, and other forms of

information technology.

Current Good Manufacturing Practices

and Related Regulations for Blood and

Blood Components—Parts 606 and 640

(21 CFR Parts 606 and 640) (OMB

Control 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

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices 41675

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

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) (21 CFR 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

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.

FDA estimates the burden of this

collection of information as follows:

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 RECORDKEEPING BURDEN1

21 CFR Section2 No. of Recordkeepers

Annual Frequency per

Recordkeeping

Total Annual

Records

Hours per Recordkeeper 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

41676 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

21 CFR Section2 No. of Recordkeepers

Annual Frequency per

Recordkeeping

Total Annual

Records

Hours per Recordkeeper Total Hours

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), 640.56(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. 3 5 percent of HCFA and FDA-registered blood establishments (0.05 X (3,400 + 3,032))

4 5 percent of FDA-registered establishments (3,032)

5 5 percent of pheresis establishments (1,349)

Dated: June 27, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16978 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1226]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Investigational Device Exemptions,

Reports, and Records

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 August 7,

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.

Investigational Device Exemptions,

Reports, and Records—21 CFR Part 812

(OMB Control No. 0910–0078)—

Extension

Section 520(g) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360j(g)) establishes the statutory

authority to collect information

regarding investigational devices and

establishes rules under which new

medical devices may be tested using

human subjects in a clinical setting. The

FDA Modernization Act of 1997 added

section 520(g)(6) to the act and

permitted changes to be made to either

the investigational device or to the

clinical protocol without FDA approval

of an investigational device exemption

(IDE) supplement.

An IDE allows a device, which would

otherwise be subject to provisions of the

act, such as premarket notification or

premarket approval, to be used in

investigations involving human subjects

in which the safety and effectiveness of

the device is being studied. The purpose

of part 812 (21 CFR part 812) is to

encourage, to the extent consistent with

the protection of public health and

safety and with ethical standards, the

discovery and development of useful

devices intended for human use. The

IDE regulation is designed to encourage

the development of useful medical

devices and allow investigators the

maximum freedom possible, without

jeopardizing the health and safety of the

public or violating ethical standards.

To do this, the regulation provides for

different levels of regulatory control

depending on the level of potential risk

the investigational device presents to

human subjects. Investigations of

significant risk devices, those that

present a potential for serious harm to

the rights, safety, or welfare of human

subjects, are subject to the full

requirements of the IDE regulation.

Nonsignificant risk device

investigations, those that do not present

a potential for serious harm, are subject

to the reduced burden of the abbreviated

requirements.

The regulation also includes

provisions for treatment IDE’s. The

purpose of these provisions is to

facilitate the availability, as early in the

device development process as possible,

of promising new devices to patients

with life-threatening or serious

conditions for which no comparable or

satisfactory alternative therapy is

available.

Section 812.10 allows the sponsor of

the IDE to request a waiver to all of the

requirements of part 812. This

information is needed for FDA to

determine if waiver of the requirements

of part 812 will impact the public’s

health and safety.

Sections 812.20, 812.25, and 812.27,

consist of the information necessary to

file an IDE application with FDA. The

submission of an IDE application to

FDA is required only for significant risk

device investigations. Section 812.20

lists the data requirements for the

original IDE application, § 812.25 lists

the contents of the investigational plan,

and § 812.27 lists the data relating to

previous investigations or testing. The

information in this original IDE

application is evaluated by the Center

for Devices and Radiological Health to

determine whether the proposed

investigation will reasonably protect the

public health and safety, and for FDA to

make a determination to approve the

IDE.

Once FDA approves an IDE

application, a sponsor must submit

certain requests and reports. Under

§ 812.35, a sponsor who wishes to make

a change in the investigation which

affects the scientific soundness of the

study or the rights, safety, or welfare of