Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0510]

Agency Information Collection Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 reinstatement of an existing collection of

information, and allow 60 days for public comment in response to the

notice. This notice solicits comments on the recordkeeping requirements

for manufacturers of medicated animal feeds.

DATES: Submit written comments on the collection of information by

February 23, 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: Denver Presley, Office of Information

Resources Management (HFA-250), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-827-1472.

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

[[Page 67077]]

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 reinstatement 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 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 Practice Regulations for Medicated

Feeds--(21 CFR Part 225)--(OMB Control Number 0910-0152--

Reinstatement)

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 growth

promotion and feed efficiency. Statutory requirements for CGMP's have

been codified under part 225 (21 CFR 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 ensure that proper quality control

is maintained. Such records would, e.g., 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 to 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

ensure 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 mixer-feeders.

Table 1.--Estimated Annual Recordkeeping Burden (Registered License Holders)1 2

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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225.42(b)(5) through

(b)(8) 1,600 24 38,400 0.41 16,000

225.58(c) and (d) 1,600 24 38,400 0.25 9,600

225.80(b)(2) 1,600 24 38,400 0.16 6,400

225.102(b)(1)

through (b)(5) 1,600 24 38,400 1.0 38,400

225.110(b)(1) and

(b)(2) 1,600 24 38,400 0.25 9,600

225.115(b)(1) and

(b)(2) 1,600 24 38,400 0.25 9,600

Total 89,600

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

information.

\2\ Commercial feed mills.

Table 2.--Estimated Annual Recordkeeping Burden (Registered License Holders)1 2

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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225.42(b)(5) through

(b)(8) 200 3 600 0.16 100

225.58(c) and (d) 200 3 600 0.16 100

225.80(b)(2) 200 3 600 0.083 50

225.102(b)(1)

through (b)(5) 200 3 600 0.5 300

225.110(b)(1) and

(b)(2) 3

225.115(b)(1) and

(b)(2) 3

Total 550

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

information.

\2\ Mixer-feeders.

\3\ There is no burden because medicated feeds are consumed on site (225.110 Distribution Records; 225.115--

Complaint files).

[[Page 67078]]

Table 3.--Estimated Annual Recordkeeping Burden (Nonregistered)1 2

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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225.142 13,000 24 316,800 0.41 132,000

225.158 13,000 24 316,800 0.25 79,200

225.180 13,000 24 316,800 0.16 52,800

225.202 13,000 24 316,800 1.5 475,200

Total 739,200

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

information.

\2\ Commercial feed mills.

Table 4.--Estimated Annual Recordkeeping Burden (Nonregistered)1 2

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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225.142 45,000 3 135,000 0.16 22,500

225.158 45,000 3 135,000 0.16 22,500

225.180 45,000 3 135,000 0.083 11,250

225.202 45,000 3 135,800 0.5 67,500

Total 123,750

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

information.

\2\ Mixer-feeders.

The estimate of the times required for record preparation and

maintenance is based on agency communications with industry. Other

information needed to finally calculate the total burden hours (i.e.,

number of recordkeepers, number of medicated feeds being manufactured,

etc.) is derived from agency records and experience.

Dated: December 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-33487 Filed 12-22-97; 8:45 am]

BILLING CODE 4160-01-F