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

Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Notices 32629

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

21 CFR Section No. of

Recordkeepers

Annual Frequency of

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

226.115 115 10 1,150 0.5 575

Total 157,550

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

The estimate of the time required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

calculate the total burden hours (i.e.,

manufacturing sites, number of Type A

medicated articles being manufactured,

etc.) is derived from agency records and

experience.

Dated: June 8, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15080 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–0046]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Current

Good Manufacturing Practice

Regulations for Medicated Feeds

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 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 Medicated Feeds—21

CFR Part 225 (OMB Control No. 0910–

0152)—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

medicated feeds. 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 have been

codified in part 225 (21 CFR part 225).

Medicated feeds that are not

manufactured in accordance with these

regulations are considered adulterated

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

Under part 225, a manufacturer is

required to establish, maintain, and

retain records for a medicated feed,

including records to document

procedures required during 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),

labels, and product distribution. This

information is needed so that FDA can

monitor drug usage and possible

misformulation of medicated feeds, to

investigate violative drug residues in

products from treated animals and

investigate product defects when a drug

is recalled. In addition, FDA will use

the CGMP criteria in part 225 to

determine whether or not the systems

and procedures used by manufacturers

of medicated feeds are adequate to

assure that their feeds meet the

requirements of the act as to safety and

also meet their claimed identity,

strength, quality, and purity, as required

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

A license is required when the

manufacturer of a medicated feed

involves the use of a drug or drugs,

which FDA has determined requires

more control because of the need for a

withdrawal period before slaughter or

carcinogenic concerns. Conversely, for

those medicated feeds for which FDA

has determined that the drugs used in

their manufacture need less control, a

license is not required and the

recordkeeping requirements are less

demanding. Respondents to this

collection of information are

commercial feed mills and mixerfeeders.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED COMMERCIAL FEED MILLS)1

21 CFR Section No. of Recordkeepers Annual Frequency per

Recordkeeping Total Annual Records Hours perRecordkeeper Total Hours

225.42(b)(5)

through

(b)(8) 1,150 260 299,000 1 299,000

225.58 and

(d) 1,150 45 51,750 .5 25,875

225.80(b)(2) 1,150 1,600 1,840,000 .12 220,800

225.102(b)(1) 1,150 7,800 8,970,000 .08 717,600

225.110(b)(1)

and (b)(2) 1,150 7,800 8,970,000 0.15 134,550