65274 Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Notices

patients. In 1982, when FDA revoked a

planned initiative to require mandatory

patient package inserts for all Rx drugs

in favor of private sector initiatives in

this area, the agency indicated that it

will periodically conduct surveys to

evaluate the availability of adequate

patient information on a nationwide

basis. Surveys of consumers about their

receipt of Rx drug information were

carried out in 1982, 1984, 1992, 1994,

and 1996. This notice is in regard to

continuing the survey in years 1998 and

2000.

The survey is conducted by telephone

on a national random sample of adults

age 18 and over who received a new

prescription for themselves or a

household member within the past 4

weeks. The interview assesses the extent

to which oral and written information

was received from the doctor, the

pharmacist, and other sources. Survey

respondents are also asked attitudinal

questions, and demographic and other

background characteristics are also

obtained. The survey enables FDA to

determine the frequency with which

such information is provided to

consumers. Without this information,

the agency would be unable to assure

that adequate Rx labeling and

information is provided.

Respondents to this collection of

information are adults (18 years or

older) in the continental United States

who have obtained one or more new

(nonrefill) prescriptions at a pharmacy

for themselves or a member of their

household in the last 4 weeks.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Year No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

1998 11,044 1 11,044 .03 331

1999 0 0 0 0 0

2000 11,044 1 11,044 .03 331

Annual average 7,363 7,363 221

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

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1

Year No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

1998 1,000 1 1,000 .323 20

1999 0 0 0 0 0

2000 1,000 1 1,000 .32 320

Annual average 667 667 213

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

This estimate of 434 total annual

burden hours is based on the 1996

survey administration, in which 11,044

potential respondents were contacted to

obtain 1,000 interviews.

Dated: December 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32460 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–0486]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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

requirements governing the registration

of producers of drugs and listing of

drugs in commercial distribution.

DATES: Submit written comments on the

collection of information by February 9,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. 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

1320.39(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 listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed
Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Notices 65275

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.

Registration of Producers of Drugs and

Listing of Drugs in Commercial

Distribution (21 CFR Part 207)—(OMB

Control Number 0910–0045—Extension)

Under section 510 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360), FDA is authorized to

establish a system for registration of

producers of drugs and for listing of

drugs in commercial distribution. To

implement section 510 of the act, FDA

issued part 207 (21 CFR part 207). The

regulations require an initial listing of

products and a twice-yearly update. In

addition, all registered drug firms are

required to re-register annually between

January and July. The penalties for

failure to register or drug list are

potential seizure and injunctions, as

well as criminal enforcement actions.

The following are the specific

reporting requirements under part 207:

(1) Section 207.20 requires that owners

and operators of all drug establishments

that engage in the manufacture,

preparation, propagation, or processing

of drugs must register and use Form

FDA 2656 (Registration of Drug

Establishment) and Form FDA 2658

(Registered Establishments’ Report of

Private Label Distributors) to submit

drug listing information or to request a

Labeler Code, or both. (2) Section 207.21

requires that owners and operators must

register an establishment within 5 days

of beginning operations and shall

complete Form FDA 2656e (Annual

Registration of Drug Establishment) each

year between January and July. Annual

registration forms are mailed by the

FDA in each calendar year according to

a schedule based on the establishment

parent company’s name and must be

completed within 30 days of the receipt.

(3) Section 207.22(a) requires that Form

FDA 2656 must be submitted when an

establishment registers the first time. An

establishment whose drug registration is

validated under § 207.35(a) is required

to make subsequent annual registrations

as described in § 207.21(a). (4) Section

207.22(b) requires that Form FDA 2657

must be submitted for the first listing of

drugs and subsequent June and

December updates. (5) Section 207.25

specifies the information required in the

establishment registration and drug

listing. (6) Section 207.25(c) specifies

the information about the drug that is

required to be submitted (name, active

ingredients, dosage strength, NDC

number, manufacturer or distributor,

size, shape, color, code imprint). (7)

Section 207.26 specifies the information

required in the amendments to the

establishment registration. (8) Section

207.30 specifies the information

required for updating the drug listing.

(9) Section 207.31 specifies additional

drug listing information that may be

needed beyond that required in

§§ 207.25 and 207.30.

The information obtained from the

establishment registration forms FDA

2656 and FDA 2656(e) is used by FDA

and other government agencies to keep

an accurate and current list of all human

and animal drug manufacturers,

repackers, relabelers and other drug

processors located in this country. This

list is used by FDA for inspectional

purposes as required by the act. In

addition, the data is used by the public

and private sector as a listing of the

names and locations of drug firms. The

information obtained from the listing

forms FDA–2657 and FDA–2658 is

used, through assignment of the

National Drug Code numbers, for third

party reimbursement payment in

Medicare and Medicaid as well as other

health care insurance firms.

Respondents to this collection of

information are all owners and

operators that engage in the

manufacture, preparation, propagation,

compounding, or processing of drugs

and that are not exempt under section

510(g) of the act or subpart D of 21 CFR

207.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form 21 CFR Section No. of

Respondents

No. of

Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

Form FDA–2656 Registration of

Drug Establishment 207.20

207.22

207.25

207.26

2,500 1 2,500 .5 1,250

Form FDA–2656(e) Annual Reregistration of Drug Establishments 207.21

207.25

207.26

9,000 1 9,000 .5 4,500

Form FDA–2657 Drug Product

Listing Form 207.22

207.30

207.31

45,000 1 45,000 .5 22,500

Form FDA–2658 Registered Establishment’s Report of Private

Label Distribution 207.20

207.21

207.25

207.26

6,200 1 6,200 .5 3,100

207.25(c) 1,500 12.04 18,066 .5 9,033

Total 40,383

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