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Federal Register / Vol. 71, No.

186 / Tuesday, September 26, 2006 / Notices 56153

in the spread of these pathogens. 5. Centers for Disease Control and Draft Guidance for Industry and Food
Pathogens that can cause diseases after Prevention. Foodborne Outbreak of and Drug Administration Staff:
an infected person handles food are the Cryptosporidiosis-Spokane, Recommendations for Clinical
following: Washington, 1997. MMWR 1998; 47:27. Laboratory Improvement Amendments
Noroviruses. 6. Noel JS, Humphrey CD, Rodriguez (CLIA) of 1988 Waiver Applications;
Hepatitis A virus. EM, et al., Parkville virus: A novel Availability
Salmonella Typhi.* genetic variant of human calicivirus in
Shigella species. Congress passed the CLIA (Public Law
the sapporo virus clade, associated with
Staphylococcus aureus. 100–578) in 1988 to establish quality
an outbreak of gastroenteritis in adults.
Streptococcus pyogenes. standards for all laboratory testing. The
J. Med. Virol. 52:173–178, 1997.
purpose was to ensure the accuracy,
II. Pathogens Occasionally Transmitted Dated: September 15, 2006. reliability, and timeliness of patient test
by Food Contaminated by Infected James D. Seligman, results regardless of where the test took
Persons Who Handle Food, But Usually Chief Information Officer, Centers for Disease place. CLIA requires that clinical
Transmitted by Contamination at the Control and Prevention (CDC). laboratories obtain a certificate from the
Source or in Food Processing or by [FR Doc. E6–15712 Filed 9–25–06; 8:45 am] Secretary of Health and Human Services
Non-foodborne Routes BILLING CODE 4163–18–P (the Secretary) before accepting
Other pathogens are occasionally materials derived from human body for
transmitted by infected persons who laboratory tests (42 U.S.C. 263a(b)).
handle food, but usually cause disease DEPARTMENT OF HEALTH AND Laboratories that perform only tests
when food is intrinsically contaminated HUMAN SERVICES that are ‘‘simple’’ and that have an
or cross-contaminated during processing ‘‘insignificant risk of an erroneous
or preparation. Bacterial pathogens in Food and Drug Administration
result’’ may obtain a certificate of
this category often require a period of waiver (42 U.S.C. 263a (c)(2)). The
temperature abuse to permit their [Docket No. 2001D–0044] Secretary has delegated to FDA the
multiplication to an infectious dose authority to determine whether
before they will cause disease in Agency Information Collection particular tests (waived tests) are ‘‘
consumers. Preventing food contact by Activities; Submission for Office of simple’’ and have ‘‘an insignificant risk
persons who have an acute diarrheal Management and Budget Review; of an erroneous result’’ under CLIA (69
illness will decrease the risk of Comment Request; Draft Guidance for FR 22849, April 27, 2004). This
transmitting the following pathogens: Industry and Food and Drug guidance document describes
Administration Staff: recommendations for device
Campylobacter jejuni.
Cryptosporidium parvum.
Recommendations for Clinical manufacturers submitting to FDA an
Entamoeba histolytica. Laboratory Improvement Amendments application for determination that a
Enterohemorrhagic Escherichia coli. of 1988 Waiver Applications; cleared or approved device meets CLIA
Enterotoxigenic Escherichia coli. Availability standards (CLIA waiver application).
Giardia lamblia.
Nontyphoidal Salmonella. AGENCY: Food and Drug Administration, The guidance recommends that CLIA
Sapoviruses. HHS. waiver applications include a
Taenia solium. ACTION: Notice. description of the features of the device
Vibrio cholerae. that make it ‘‘simple’’: A report
Yersinia enterocolitica. SUMMARY: The Food and Drug describing a hazard analysis that
References Administration (FDA) is announcing identifies potential sources of error,
that a proposed collection of including a summary of the design and
1. World Health Organization. Health information has been submitted to the results of flex studies and conclusions
surveillance and management Office of Management and Budget drawn from the flex studies; a
procedures for food-handling personnel: (OMB) for review and clearance under description of fail-safe and failure alert
report of a WHO consultation. World the Paperwork Reduction Act of 1995. mechanism and a description of the
Health Organization technical report studies validating these mechanisms; a
series; 785. Geneva: World Health DATES: Fax written comments on the
collection of information by October 26, description of clinical tests that
Organization, 1989. demonstrate accuracy of the test in the
2. Frank JF, Barnhart HM. Food and 2006.
hands of intended operators; and
dairy sanitation. In: Last JM, ed. Maxcy- ADDRESSES: To ensure that comments on statistical analysis of clinical study
Rosenau public health and preventive the information collection are received, results. The guidance also make
medicine, 12th edition. New York OMB recommends that written recommendations concerning labeling
Appleton-Century-Crofts, 1986:765–806. comments be faxed to the Office of of ‘‘waived tests.’’ The burden
3. Bennett JV, Holmberg SD, Rogers Information and Regulatory Affairs, associated with most of these labeling
MF, Solomon SL. Infectious and OMB, Attn: FDA Desk Officer, FAX: recommendations is approved under
parasitic diseases. In: Amler RW, Dull 202–395–6974. OMB control number 0910–0485.
HB, eds. Closing the gap: the burden of FOR FURTHER INFORMATION CONTACT:
unnecessary illness. New York: Oxford Only new information collections not
Denver Presley, Office of Management already approved, are included in the
University Press, 1987:102–114. Programs (HFA–250), Food and Drug
4. Centers for Disease Control and estimate in this document.
Administration, 5600 Fishers Lane, Recommendations for quick reference
Prevention. Locally acquired
Rockville, MD 20857, 301–827–1472. instructions are written in simple
neurocysticercosis—North Carolina,
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Massachusetts, and South Carolina, SUPPLEMENTARY INFORMATION: In language that can be posted. The
1989–1991. MMWR 1992; 41:1–4. compliance with 44 U.S.C. 3507, FDA guidance also notes that ‘‘waived tests’’
has submitted the following proposed remain subject to applicable reporting
* Kauffmann-White scheme for designation of collection of information to OMB for and recordkeeping requirements under
Salmonella serotypes. review and clearance. 21 CFR part 803. The burden associated

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56154 Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices

with this provision is approved under In the Federal Register of September FDA estimates the burden of this
OMB control number 0910–0437. 7, 2005 (70 FR 53231), FDA solicited collection of information as follows:
Respondents to this collection of comments on the collection of
information are manufacturers of in information requirements. No comments
vitro diagnostic devices. were received in response to this notice.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


Total Operating &
Annual Frequency Total Annual Re- Hours per
No of Respondents Total Hours Maintenance
per Response sponses Response Costs

40 1 40 780 31,200 $5,500


1There are no capital costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


Total Operating &
Annual Frequency Total Annual
No. of Recordkeepers Hours per Record Total Hours Maintenance
per Recordkeeper Records Costs

40 1 40 2,800 112,000 $60,700


1There are no capital costs associated with this collection of information.

Based on previous years of DEPARTMENT OF HEALTH AND Administration, 5630 Fishers Lane, rm.
experience, with CLIA waiver HUMAN SERVICES 1061, Rockville, MD 20852. All
applications, FDA expects 40 comments should be identified with the
manufacturers to apply for one CLIA Food and Drug Administration docket number found in brackets in the
waiver per year. The annual reporting heading of this document.
[Docket No. 2006N–0357]
burden to respondents is estimated to be FOR FURTHER INFORMATION CONTACT:
31,200 hours and the recordkeeping Agency Information Collection Jonna Capezzuto, Office of Management
burden for respondents is estimated to Activities; Proposed Collection; Programs (HFA–250), Food and Drug
be 112,00 hours. FDA based the Comment Request; Procedures for the Administration, 5600 Fishers Lane,
reporting and recordkeeping burden on Safe and Sanitary Processing and Rockville, MD 20857, 301–827–4659.
agency analysis of premarket Importing of Fish and Fishery Products SUPPLEMENTARY INFORMATION: Under the
submissions with clinical trials similar PRA (44 U.S.C. 3501–3520), Federal
AGENCY: Food and Drug Administration, agencies must obtain approval from the
to the waived laboratory tests. HHS. Office of Management and Budget
The total operating and maintenance ACTION: Notice. (OMB) for each collection of
costs associated with the
information they conduct or sponsor.
implementation of this draft guidance is SUMMARY: The Food and Drug
‘‘Collection of information’’ is defined
estimated to be $66,200. The cost Administration (FDA) is announcing an in 44 U.S.C. 3502(3) and 5 CFR
consists of specimen collections for the opportunity for public comment on the 1320.3(c) and includes agency requests
clinical study (estimated at $23,500); proposed collection of certain or requirements that members of the
laboratory supplies, reference testing, information by the agency. Under the public submit reports, keep records, or
and study oversight (estimated at Paperwork Reduction Act of 1995 (the provide information to a third party.
$26,700); shipping and office supplies PRA), Federal agencies are required to Section 3506(c)(2)(A) of the PRA (44
(estimated at $6,000); and educational publish notice in the Federal Register U.S.C. 3506(c)(2)(A)) requires Federal
materials, including quick reference concerning each proposed collection of agencies to provide a 60–day notice in
instructions (estimated at $10,000). information, including each proposed the Federal Register concerning each
extension of an existing collection of proposed collection of information,
Dated: September 15, 2006. information, and to allow 60 days for including each proposed extension of an
Jeffrey Shuren, public comment in response to the existing collection of information,
Assistant Commissioner for Policy. notice. This notice solicits comments on before submitting the collection to OMB
[FR Doc. E6–15693 Filed 9–25–06; 8:45 am] extending OMB approval on the existing for approval. To comply with this
BILLING CODE 4160–01–S
reporting and recordkeeping requirement, FDA is publishing notice
requirements for processors and of the proposed collection of
importers of fish and fishery products. information set forth in this document.
DATES: Submit written or electronic With respect to the following
comments on the collection of collection of information, FDA invites
information by November 27, 2006. comments on these topics: (1) Whether
ADDRESSES: Submit electronic the proposed collection of information
comments on the collection of is necessary for the proper performance
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information to: http://www.fda.gov/ of FDA’s functions, including whether


dockets/ecomments. Submit written the information will have practical
comments on the collection of utility; (2) the accuracy of FDA’s
information to the Division of Dockets estimate of the burden of the proposed
Management (HFA–305), Food and Drug collection of information, including the

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