32626 Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

Type of Survey No. of Respondents Annual Frequency

per Response Hours per Response Total Hours

Phone survey .......................................................... 1,000 1 0.5 500

Internet or cable survey .......................................... 3,000 1 1 3,000

Total ........................................................................ 6,500

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

These estimates are based on the

expected number of respondents

necessary to obtain a statistically

significant stratification of the average

to large size industries—including small

business entities covered by FDA

regulations—and consumers of

regulated products.

Dated: June 8, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15082 Filed 6–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0135]

Agency Information Collection

Activities; Announcement of OMB

Approval; Focus Group Study of

Radiation Disclosure Statement

Options for Foods Treated With

Ionizing Radiation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Focus Group Study of Radiation

Disclosure Statement Options for Foods

Treated with Ionizing Radiation’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

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 the

Federal Register of March 29, 2001 (66

FR 17183), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0468. The

approval expires on October 31, 2001. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: June 8, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15084 Filed 6–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1682]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Radioactive Drug Research Committee

Report on Research Use of

Radioactive Drugs Membership

Summary and Study Summary

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 (PRA).

DATES: Submit written comments on the

collection of information by July 16,

2001.

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:

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: In

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

has submitted the following proposed

collection of information to OMB for

review and clearance.

Radioactive Drug Research Committee

Report on Research Use of Radioactive

Drugs Membership Summary and Study

Summary (OMB Control No. 0910–

0053)—Extension

Under sections 201, 505, and 701 of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 355, and 371), FDA

has the authority to issue regulations

governing the use of radioactive drugs

for certain research uses. The

regulations in § 361.1 (21 CFR 361.1)

establish the conditions under which

radioactive drugs are generally

recognized as safe and effective for

certain research purposes.

The regulations in § 361.1 set forth

specific requirements for the

establishment and composition of

Radioactive Drug Research Committees

(RDRCs) and their role in approving and

monitoring the use of radioactive drugs

in certain types of research. These

radioactive drugs may not be given to

human subjects without the

authorization of an FDA-approved

RDRC (§ 361.1(d)(7)). The types of

studies authorized under § 361.1 are

those intended to obtain basic

information on the metabolism of a

radioactively labeled drug or regarding

human physiology, pathophysiology, or

biochemistry. Research intended for

immediate therapeutic, diagnostic, or

similar purposes or to determine the

safety and effectiveness of a radioactive

drug in humans (i.e., to carry out a

clinical trial) may not be conducted

under an RDRC. Research for such

purposes requires the submission of an

investigational new drug application

under 21 CFR part 312.

Section 361.1 requires the RDRCs to

perform various activities involving the

collection of information and reporting

to FDA that are subject to the PRA.

Under § 361.1(c)(2), each RDRC must do

the following: (1) Select a chairman who

must sign all applications, minutes, and

reports of the committee; (2) meet at

Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Notices 32627

least once each quarter in which

research is authorized or performed; and

(3) keep minutes and include the

numerical results of votes on protocols

involving use in human subjects. Under

§ 361.1(c)(3), each RDRC must submit an

annual report to FDA that includes the

names and qualifications of the

members of, and of any consultants

used by, the RDRC. It must also include,

for each study conducted during the

preceding year, a summary of

information using Form FDA 2915.

Under § 361.1(d)(5), each investigator

must obtain the proper informed

consent required under the regulations.

Each female research subject of

childbearing potential must state in

writing that she is not pregnant or be

confirmed as not pregnant on the basis

of a pregnancy test before participating

in any study. Under § 361.1(d)(8), each

investigator must immediately report to

the RDRC all adverse effects associated

with use of the radioactive drug in the

research study, and the RDRC must

report to FDA all adverse reactions

probably attributable to such use.

Section 361.1(f) specifies labeling

requirements for radioactive drugs for

these research uses. These requirements

are not in the reporting burden estimate

because they are information supplied

by the Federal Government to the

recipient for the purposes of disclosure

to the public (5 CFR 1320.3(c)(2)).

The primary purpose of this

collection of information is to determine

if these research studies involving

radioactive drugs are being conducted

in accordance with regulations. If these

studies were not reviewed, human

subjects might be subjected to

inappropriate radiation and/or other

safety risks. Individuals responsible for

the collection of this information are the

chairpersons of each RDRC, and

investigators in the studies.

The estimate of the paperwork burden

was based on a survey of three different

RDRC chairpersons. The three RDRCs

reflect different geographical areas and

varying levels of RDRC membership and

activities. The chairpersons provided

their assessments of time expended,

cost, and ease of completing the

necessary reporting forms.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours

361.1(c)(3) FDA 2914 96 1.0 96 1 96

361.1(c)(3) FDA 2915 63 5 315 3.5 1,103

361.1(d)(5) 63 5 315 0.1 31

361.1(d)(8) 63 5 315 0 0

Total 1,230

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 Form Annual Frequency

per Recordkeeping Total Annual Records Hours perRecordkeeper Total Hours

361.1(c)(2) FDA 2914 and 2915 96 1 per quarter 4 per year 10 960

Total 960

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

In the Federal Register of January 5,

2001 (66 FR 1137), the agency requested

comments on the continued collections

of RDRC annual report information,

using Form FDA 2914 and Form FDA

2915, which expire on October 31, 2001.

These forms cannot be used after this

date unless they have a valid OMB

control number.

The agency received two written

responses to the proposed continued

collections of information; they

contained a total of six comments. The

comments received and respective

responses are listed below:

1. The comment maintained that FDA

has never had any actual statutory

authority over radioactive drugs used

for basic research and the extensive

paperwork requirements for § 361.1

should be completely removed.

This comment involves substantive

changes to the regulations and is beyond

the scope of the January 5, 2001, notice.

In the Federal Register of November 30,

2000 (65 FR 73799), FDA announced, as

part of the semiannual regulatory

agenda, that it intends to publish a

proposed rule to revise § 361.1 to update

FDA’s regulations on the use of

radioactive drugs for basic research to

reflect technological changes in the field

of radiopharmaceuticals and to clarify

and correct certain provisions. It would

be more appropriate to submit this

comment in response to the proposed

rule once FDA publishes it.

2. The comment maintained that the

term ‘‘radiation dose commitment to

whole body’’ is unclear and that

reporting the ‘‘absorbed dose to whole

body’’ on Form FDA 2915 is

inappropriate. The comment stated that

more appropriate calculations of body

dose involve the summation of

individual organ doses multiplied by

organ weighting factors (e.g., effective

dose equivalent or effective dose).

This comment is beyond the scope of

the January 5, 2001, notice and would

more appropriately be submitted as a

comment on the proposed rule that FDA

intends to publish.

3. The comment maintained that the

instructions and table headings on Form

FDA 2915 require absorbed doses to be

in units of ‘‘mR’’ though this is a unit

of exposure rather than absorbed dose.

The comment suggests that the unit of

rad or gray should be used.

FDA intends to change Form FDA

2915 to require the total radiation doses

and dose commitments, expressed in

the unit of rem (§ 361.1(b)).

4. The comment maintained that the

reporting requirements for gender and

age of each human subject over 18 years

of age are unnecessary and should be

deleted.

This comment is beyond the scope of

the January 5, 2001, notice and would

more appropriately be submitted as a

comment on the proposed rule that FDA

intends to publish.

32628 Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Notices

5. The comment recommends that

absorbed doses for individual subjects

who are also representative subjects, or

absorbed doses for individual subjects

that are less than those estimated for a

representative subject, be eliminated

from the annual reporting requirements.

This comment is beyond the scope of

the January 5, 2001, notice and would

more appropriately be submitted as a

comment on the proposed rule that FDA

intends to publish.

6. The comment maintains that the

estimated annual reporting burden

stated in table 1 of the January 5, 2001,

notice underestimates the time required

for completion of Form FDA 2915 as it

currently exists. The respondent

estimates that the time expended to

complete an annual summary on Form

FDA 2915 is approximately 10 hours,

rather than the 3.5 hours stated.

FDA appreciates the comment but

believes that 3.5 hours is a reasonable

estimate of the average time it takes to

complete the form. However, FDA

recognizes that the paperwork burden

may vary from committee to committee.

FDA’s survey of RDRC chairpersons

attempted to reflect differences in RDRC

membership and scope of activities.

Based on this comment, FDA may

further examine and evaluate the role,

functions, and activities of RDRC and its

related paperwork burden in the future.

Dated: June 8, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15079 Filed 6–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0048]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Current

Good Manufacturing Practice

Regulations for Type A Medicated

Articles

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 July 16,

2001.

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:

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 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Current Good Manufacturing Practice

Regulations for Type A Medicated

Articles—21 CFR Part 226 (OMB

Control No. 0910–0154)—Extension

Under section 501 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 351), FDA has the statutory

authority to issue current good

manufacturing practice (CGMP)

regulations for drugs, including Type A

medicated articles. A Type A medicated

article is a feed product containing a

concentrated drug diluted with a feed

carrier substance. A Type A medicated

article is intended solely for use in the

manufacture of another Type A

medicated article or a Type B or Type

C medicated feed. Medicated feeds are

administered to animals for the

prevention, cure, mitigation, or

treatment of disease or for growth

promotion and feed efficiency.

Statutory requirements for CGMPs for

Type A medicated articles have been

codified at part 266 (21 CFR part 226).

Type A medicated articles that are not

manufactured in accordance with these

regulations are considered adulterated

under section 501(a)(2)(B) of the act.

Under part 226, a manufacturer is

required to establish, maintain, and

retain records for Type A medicated

articles, including records to document

procedures required under the

manufacturing process to assure that

proper quality control is maintained.

Such records would, for example,

contain information concerning receipt

and inventory of drug components,

batch production, laboratory assay

results (i.e., batch and stability testing),

and product distribution. This

information is needed so that FDA can

monitor drug usage and possible

misformulation of Type A medicated

articles. The information could also

prove useful to FDA in investigating

product defects when a drug is recalled.

In addition, FDA will use the CGMP

criteria in part 226 to determine

whether or not the systems used by

manufacturers of Type A medicated

articles are adequate to assure that their

medicated articles meet the

requirements of the act as to safety and

also meet the articles, claimed identity,

strength, quality, and purity, as required

by section 501(a)(2)(B) of the act.

The respondents for Type A

medicated articles are pharmaceutical

firms that manufacture both human and

veterinary drugs, those firms that

produce only veterinary drugs and

commercial feed mills.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual Frequency of

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

226.42 115 260 29,000 0.75 22,425

226.58 115 260 29,000 1.75 52,325

226.80 115 260 29,000 0.75 22,425

226.102 115 260 24,000 1.75 52,325

226.110 115 260 29,000 0.25 7,475