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Federal Register / Vol. 73, No.

43 / Tuesday, March 4, 2008 / Notices 11649

collection provisions should be Administration, 5630 Fishers Lane, Rm. be injurious to health or that are
extended to provide for the potential 1061, Rockville, MD 20852. All otherwise adulterated, as defined in
future need of a State or local comments should be identified with the section 402 of the act (21 U.S.C. 342).
government to petition for an exemption docket number found in brackets in the Under the authority granted to FDA by
from preemption under the provisions heading of this document. section 404 of the act (21 U.S.C. 344),
of section 403(A) of the act. FOR FURTHER INFORMATION CONTACT: FDA regulations require registration of
Please note that on January 15, 2008, Jonna Capezzuto, Office of the Chief food processing establishments, filing of
the FDA Web site transitioned to the Information Officer (HFA–250), Food process or other data, and maintenance
Federal Dockets Management System and Drug Administration, 5600 Fishers of processing and production records for
(FDMS). FDMS is a Government-wide, Lane, Rockville, MD 20857, 301–827– acidified foods and thermally processed
electronic docket management system. 4659. low-acid foods in hermetically sealed
Electronic submissions will be accepted containers. These requirements are
SUPPLEMENTARY INFORMATION: Under the
by FDA through FDMS only. intended to ensure safe manufacturing,
PRA (44 U.S.C. 3501–3520), Federal processing, and packing procedures and
Dated: February 26, 2008. agencies must obtain approval from the
Jeffrey Shuren,
to permit FDA to verify that these
Office of Management and Budget procedures are being followed.
Assistant Commissioner for Policy. (OMB) for each collection of Improperly processed low-acid foods
[FR Doc. E8–4066 Filed 3–3–08; 8:45 am] information they conduct or sponsor. present life-threatening hazards if
BILLING CODE 4160–01–S ‘‘Collection of information’’ is defined contaminated with foodborne
in 44 U.S.C. 3502(3) and 5 CFR microorganisms, especially Clostridium
1320.3(c) and includes agency requests botulinum. The spores of C. botulinum
DEPARTMENT OF HEALTH AND or requirements that members of the must be destroyed or inhibited to avoid
HUMAN SERVICES public submit reports, keep records, or production of the deadly toxin that
provide information to a third party. causes botulism. This is accomplished
Food and Drug Administration Section 3506(c)(2)(A) of the PRA (44 with good manufacturing procedures,
[Docket No. FDA–2008–N–0129] U.S.C. 3506(c)(2)(A)) requires Federal which must include the use of adequate
agencies to provide a 60-day notice in heat processes or other means of
Agency Information Collection the Federal Register concerning each preservation.
Activities; Proposed Collection; proposed collection of information, To protect the public health, FDA
Comment Request; Food Canning including each proposed extension of an regulations require that each firm that
Establishment Registration, Process existing collection of information, manufactures, processes, or packs
Filing, and Recordkeeping for Acidified before submitting the collection to OMB acidified foods or thermally processed
Foods and Thermally Processed Low- for approval. To comply with this low-acid foods in hermetically sealed
Acid Foods in Hermetically Sealed requirement, FDA is publishing notice containers for introduction into
Containers of the proposed collection of interstate commerce register the
information set forth in this document. establishment with FDA using Form
AGENCY: Food and Drug Administration, With respect to the following
HHS. FDA 2541 (§§ 108.25(c)(1) and
collection of information, FDA invites 108.35(c)(2) (21 CFR 108.25(c)(1) and
ACTION: Notice. comments on these topics: (1) Whether 108.35(c)(2))). In addition to registering
SUMMARY: The Food and Drug
the proposed collection of information the plant, each firm is required to
Administration (FDA) is announcing an is necessary for the proper performance provide data on the processes used to
opportunity for public comment on the of FDA’s functions, including whether produce these foods, using Form FDA
proposed collection of certain the information will have practical 2541a for all methods except aseptic
information by the agency. Under the utility; (2) the accuracy of FDA’s processing, or Form FDA 2541c for
Paperwork Reduction Act of 1995 (the estimate of the burden of the proposed aseptic processing of low-acid foods in
PRA), Federal agencies are required to collection of information, including the hermetically sealed containers
publish notice in the Federal Register validity of the methodology and (§§ 108.25(c)(2) and 108.35(c)(2)). Plant
concerning each proposed collection of assumptions used; (3) ways to enhance registration and process filing may be
information, including each proposed the quality, utility, and clarity of the accomplished simultaneously. Process
extension of an existing collection of information to be collected; and (4) data must be filed prior to packing any
information, and to allow 60 days for ways to minimize the burden of the new product, and operating processes
public comment in response to the collection of information on and procedures must be posted near the
notice. This notice solicits comments on respondents, including through the use processing equipment or made available
reporting and recordkeeping of automated collection techniques, to the operator (§ 113.87(a) (21 CFR
requirements for firms that process when appropriate, and other forms of 113.87(a))).
information technology. Regulations in parts 108, 113, and 114
acidified foods and thermally processed
(21 CFR parts 108, 113, and 114) require
low-acid foods in hermetically sealed Food Canning Establishment firms to maintain records showing
containers. Registration, Process Filing, and adherence to the substantive
DATES: Submit written or electronic Recordkeeping for Acidified Foods and requirements of the regulations. These
comments on the collection of Thermally Processed Low-Acid Foods records must be made available to FDA
information by May 5, 2008. in Hermetically Sealed Containers—21 on request. Firms are also required to
ADDRESSES: Submit electronic CFR 108.25 and 108.35, and Parts 113 document corrective actions when
comments on the collection of and 114 (OMB Control Number 0910– process controls and procedures do not
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information to http:// 0037)—Extension fall within specified limits (§§ 113.89,


www.regulations.gov. Submit written Under the Federal Food, Drug, and 114.89, and 114.100(c)); to report any
comments on the collection of Cosmetic Act (the act), FDA is instance of potential health-endangering
information to the Division of Dockets authorized to prevent the interstate spoilage, process deviation, or
Management (HFA–305), Food and Drug distribution of food products that may contamination with microorganisms

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11650 Federal Register / Vol. 73, No. 43 / Tuesday, March 4, 2008 / Notices

where any lot of the food has entered health (§§ 108.25(e) and 108.35(f)). To marked with an identifying code
distribution in commerce (§§ 108.25(d) permit lots to be traced after (§§ 113.60(c) (thermally processed
and 108.35(d) and (e)); and to develop distribution, acidified foods and foods) and 114.80(b) (acidified foods)).
and keep on file plans for recalling thermally processed low-acid foods in FDA estimates the burden of this
products that may endanger the public hermetically sealed containers must be collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
Form No. 21 CFR Section Total Hours
Respondents per Response Responses Response

Form FDA 2541 (Registration) 108.25 and 108.35 515 1 515 .17 88

Form FDA 2541a (Process Filing) 108.25 and 108.35 1,489 8.62 12,835 .333 4,274

Form FDA 2541c (Process Filing) 108.35 84 7.77 653 .75 490

Total 4,852
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


No. of Annual Frequency Total Annual Hours per
21 CFR Part Total Hours
Recordkeepers of Recordkeeping Records Recordkeeper

113 and 114 8,950 1 8,950 250 2,237,500


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

FDA based its estimate on DEPARTMENT OF HEALTH AND ADDRESSES: In commenting, please refer
registrations and process filings HUMAN SERVICES to file code OIG–793-PN. Because of
received over the past 3 years. The staff and resource limitations, we cannot
reporting burden for §§ 108.25(d) and Office of Inspector General accept comments by facsimile (FAX)
108.35(d) and (e) is minimal because transmission.
Privacy Act of 1974; Revisions to OIG’s
notification of spoilage, process You may submit comments in one of
Privacy Act System of Records:
deviation or contamination of product three ways (no duplicates, please):
Criminal Investigative Files
in distribution occurs less than once a 1. Electronically. You may submit
year. Most firms discover these AGENCY: Office of Inspector General electronic comments on specific
problems before the product is (OIG), HHS. recommendations and proposals
distributed and, therefore, are not through the Federal eRulemaking Portal
ACTION: Notice of proposed revisions to
required to report the occurrence. To at http://www.regulations.gov.
existing Privacy Act systems of records.
avoid double-counting, estimates for (Attachments should be in Microsoft
§§ 108.25(g) and 108.35(h) have not SUMMARY: The Office of Inspector Word, if possible.)
been included because they merely General (OIG) proposes to revise and 2. By regular, express, or overnight
cross-reference recordkeeping update the existing system of records, mail. You may send written comments
requirements contained in parts 113 and entitled ‘‘Criminal Investigative Files’’ to the following address: Office of
114. (09–90–0003). This proposed notice is Inspector General, Department of Health
Please note that on January 15, 2008, in accordance with the Privacy Act and Human Services, Attention: OIG–
the FDA Web site transitioned to the requirement that agencies publish their 793–PN, Room 5246, Cohen Building,
Federal Dockets Management System amended systems of records in the 330 Independence Avenue, SW.,
(FDMS). FDMS is a Government-wide, Federal Register when there is a Washington, DC 20201. Please allow
electronic docket management system. revision, change, or addition. This sufficient time for mailed comments to
Electronic submissions will be accepted system of records, maintained by OIG, be received before the close of the
by FDA through FDMS only. was last revised and updated on comment period.
December 8, 2006.
Dated: February 26, 2008. 3. By hand or courier. If you prefer,
Jeffrey Shuren,
DATES: Effective Date: These revisions you may deliver, by hand or courier,
will become effective without further your written comments before the close
Assistant Commissioner for Policy. notice on April 18, 2008 unless period to Office of Inspector General,
[FR Doc. E8–4067 Filed 3–3–08; 8:45 am] comments received on or before that Department of Health and Human
BILLING CODE 4160–01–S date result in a contrary determination. Services, Cohen Building, 330
Comment Date: Comments on these Independence Avenue, SW.,
revisions will be considered if we Washington, DC 20201. Because access
receive them at the addresses provided to the interior of the Cohen Building is
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below no later than 5 p.m. on April 3, not readily available to persons without
2008. Interested parties may submit Federal Government identification,
written comments on this proposed commenters are encouraged to schedule
revision to the addresses indicated their delivery with one of our staff
below. members at (202) 358–3141.

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