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Federal Register / Vol. 70, No.

172 / Wednesday, September 7, 2005 / Notices 53231

FDA carefully considers the benefits Contracts and Grants Management to the Division of Small Manufacturers,
such agreements will provide to the (HFA–500), Food and Drug International, and Consumer Assistance
public. The cooperative agreement Administration, 5600 Fishers Lane, (HFZ–220), Center for Devices and
ensures FDA’s continued participation Rockville, MD 20857, 301–827–7180, e- Radiological Health, Food and Drug
and support in the Annual mail: cynthia.polit@fda.gov or Administration, 1350 Piccard Dr.,
Environmental Design Contest. Through cpolit@oc.fda.gov. This RFA can be Rockville, MD 20850. Send one self-
a mix of science and engineering, it viewed on Grants.gov under ‘‘Grant addressed adhesive label to assist that
creates new resources and stimulates Find.’’ A copy of the complete RFA can office in processing your request, or fax
new and timely solutions to real world also be viewed on the FDA/CFSAN your request to 301–443–8818. See the
environmental problems. website at http://www.cfsan.fda.gov/ SUPPLEMENTARY INFORMATION section for
II. Eligibility Information list.html. For issues regarding the information on electronic access to the
programmatic aspects of this notice: guidance.
Competition is limited to WERC Wendy Buckler, Center for Food Safety Submit written comments concerning
because it is a unique educational and Applied Nutrition, 5100 Paint this draft guidance and the information
opportunity and is the only college level Branch Pkwy., College Park, MD 20740, collection provisions to the Division of
competition of its kind. 301–436–1926, email: Dockets Management (HFA–305), Food
WERC, a Consortium for wendy.buckler@fda.gov. and Drug Administration, 5630 Fishers
Environmental Education and Lane, rm. 1061, Rockville, MD 20852.
Technology Development, a program of Dated: September 1, 2005.
Jeffrey Shuren,
Submit electronic comments to http://
the College of Engineering at New www.fda.gov/dockets/ecomments.
Mexico State University, was Assistant Commissioner for Policy.
Identify comments with the docket
established in 1990 under a cooperative [FR Doc. 05–17731 Filed 9–6–05; 8:45 am] number found in brackets in the
agreement with the U.S. Department of BILLING CODE 4160–01–S heading of this document.
Energy. Starting in 1991, WERC has
conducted an Annual Environmental FOR FURTHER INFORMATION CONTACT:
Design Contest which is a unique DEPARTMENT OF HEALTH AND Carol Benson, Center for Devices and
educational experience for students HUMAN SERVICES Radiological Health (HFZ–440), Food
from throughout the world. The contest and Drug Administration, 9200
provides an opportunity for students to Food and Drug Administration Corporate Blvd., Rockville, MD 20850,
address real world environmental and 240–276–0443, ext. 144.
[Docket No. 2001D–0044]
food safety related problems, experience SUPPLEMENTARY INFORMATION:
a team developed project, publish Draft Guidance for Industry and Food I. Background
research papers, and network with and Drug Administration Staff:
experts and potential employers. The Recommendations for Clinical CLIA requires that clinical
contest is open to any 2-year, 4-year, or Laboratory Improvement Amendments laboratories obtain a certificate from the
graduate degree institution. A high of 1988 Waiver Applications; Secretary of Health and Human Services
school-level competition has been held Availability (the Secretary) before accepting
concurrently with the university contest materials derived from the human body
since 1997. Many of the tasks deal with AGENCY: Food and Drug Administration, for laboratory tests (42 U.S.C. 263(b)).
waste disposal, ground water HHS. Laboratories that perform only tests
contamination, nuclear waste treatment, ACTION: Notice. that are ‘‘simple’’ and that have an
and similar subjects; however in 2001, ‘‘insignificant risk of an erroneous
SUMMARY: The Food and Drug result’’ may obtain a certificate of
a food safety track was added and the Administration (FDA) is announcing the
contest was broadened to include waiver (42 U.S.C. 263a(c)(2)). The
availability of the draft guidance Secretary has delegated to FDA the
disciplines such as microbiology and entitled ‘‘Recommendations for Clinical
chemical contaminants in foods. The authority to determine under CLIA
Laboratory Improvement Amendments whether particular tests (waived tests)
FDA has supported this program since of 1988 (CLIA) Waiver Applications.’’
Fiscal Year 2000. This notice confirms are ‘‘simple’’ and have ‘‘an insignificant
FDA is issuing this draft guidance to risk of an erroneous result’’ (April 27,
FDA’s intent to fund for another 5-year recommend an approach for
project period. 2004, 69 FR 22849). This draft guidance
determining whether a laboratory test document describes recommendations
As of October 1, 2003, applicants are
may be performed by laboratories with for device manufacturers submitting to
required to have a Dun and Bradstreet
a certificate of waiver under CLIA. This FDA an application for determination
Number (DUNS) to apply for a grant or
draft guidance replaces the previous that a cleared or approved device meets
cooperative agreement from the Federal
draft guidance entitled ‘‘Guidance for this CLIA standard (CLIA waiver
Government. The DUNS number is a 9-
Clinical Laboratory Improvement application).
digit identification number, which
Amendments of 1988 (CLIA) Criteria for FDA previously issued a draft
uniquely identifies business entities.
Waiver,’’ March 1, 2001. guidance entitled ‘‘Clinical Laboratory
Obtaining a DUNS number is easy and
there is no charge. To obtain a DUNS DATES: Submit written or electronic Improvement Amendments of 1988
number, call 1–866–705–5711. You comments on this draft guidance by (CLIA) Criteria for Waiver’’ on March 1,
should identify yourself as a Federal December 6, 2005. Submit written 2001. This new draft guidance replaces
grant applicant when you contact Dun comments on the information collection the previous draft guidance.
and Bradstreet, Inc. provisions by November 7, 2005. The changes compared to the
ADDRESSES: Submit written requests for previous draft guidance include the
III. Application and Submission single copies on a 3.5″ diskette of the following: (1) Greater emphasis on
For further information or a copy of draft guidance document entitled scientifically-based flex studies and
the complete Request for Applications ‘‘Recommendations for Clinical validation studies, linked to the hazard
(RFA) contact Cynthia Polit, Grants Laboratory Improvement Amendments analysis for each device; (2) recognition
Management Specialist, Division of of 1988 (CLIA) for Waiver Applications’’ that reference methods may not be

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53232 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices

available for every device type (although manufacturers’ addresses), small CLIA requires that clinical laboratories
devices should be traceable to methods manufacturer’s assistance, information obtain a certificate from the Secretary of
of known accuracy when true reference on video conferencing and electronic Health and Human Services before
methods are available); (3) additional submissions, Mammography Matters, accepting materials derived from the
emphasis on use of quality control and other device-oriented information. human body for laboratory tests (42
procedures; (4) greater emphasis on The CDRH Web site may be accessed at U.S.C. 263a(b)). Laboratories that
intended users during studies testing http://www.fda.gov/cdrh. A search perform only tests that are ‘‘simple’’ and
the device; and (5) updated study capability for all CDRH guidance that have an ‘‘insignificant risk of an
recommendations with emphasis on use documents is available at http:// erroneous result’’ may obtain a
of patient specimens, in an intended use www.fda.gov/cdrh/guidance.html. certificate of waiver (42 U.S.C.
environment, over time. Guidance documents are also available 263a(c)(2)). The Secretary has delegated
FDA bases the recommendations in on the Division of Dockets Management to FDA the authority to determine
this draft guidance on its interpretation Internet site at http://www.fda.gov/ whether particular tests (waived tests)
of CLIA, FDA’s experience with CLIA ohrms/dockets. are ‘‘simple’’ and have ‘‘an insignificant
complexity determinations, and the risk of an erroneous result’’ under CLIA
agency’s interactions with stakeholders. IV. Paperwork Reduction Act of 1995
(69 FR 22849). This guidance document
One of the interactions with Under the Paperwork Reduction Act
describes recommendations for device
stakeholders was at an open public of 1995 (the PRA) (44 U.S.C. 3501–
manufacturers submitting to FDA an
workshop on August 14 and 15, 2000. 3520), Federal agencies must obtain
application for determination that a
In addition, a proposal presented by approval from the Office of Management
and Budget (OMB) for each collection of cleared or approved device meets this
(Advanced Medical Technology
information they conduct or sponsor. CLIA standard (CLIA waiver
Association) AdvaMed at the September
‘‘Collection of information’’ is defined application).
2003 Clinical Laboratory Improvement
Advisory Committee (CLIAC) meeting, in 44 U.S.C. 3502(3) and 5 CFR The guidance recommends that CLIA
and recommendations proposed by 1320.3(c) and includes agency requests waiver applications include a
CLIAC during the February 2004 or requirements that members of the description of the features of the device
meeting were considered in the public submit reports, keep records, or that make it ‘‘simple’’; a report
development of this guidance. provide information to a third party. describing a hazard analysis that
Section 3506(c)(2)(A) of the PRA (44 identifies potential sources of error,
II. Significance of Guidance U.S.C. 3506(c)(2)(A)) requires Federal including a summary of the design and
This draft guidance is being issued agencies to provide a 60-day notice in results of flex studies and conclusions
consistent with FDA’s good guidance the Federal Register concerning each drawn from the flex studies; a
practices regulation (21 CFR 10.115). proposed collection of information description of fail-safe and failure alert
The draft guidance when finalized will before submitting the collection to OMB mechanisms and a description of the
represent the agency’s current thinking for approval. To comply with this studies validating these mechanisms; a
on recommendations for CLIA Waiver requirement, FDA is publishing notice description of clinical tests that
Applications. It does not create or of the proposed collection of demonstrate the accuracy of the test in
confer any rights for or on any person information set forth in this document. the hands of intended operators; and
and does not operate to bind FDA or the With respect to the following statistical analyses of clinical study
public. An alternative approach may be collection of information, FDA invites results. The guidance also makes
used if such approach satisfies the comments on the following topics: (1) recommendations concerning labeling
requirements of the applicable statute Whether the proposed collection of of waived tests. The burden associated
and regulations. information is necessary for the proper with most of these labeling
performance of FDA’s functions, recommendations is approved under
III. Electronic Access including whether the information will OMB control number 0910–0485. Only
To receive ‘‘Clinical Laboratory have practical utility; (2) the accuracy of new information collections not already
Improvement Amendments of 1988 FDA’s estimate of the burden of the approved are included in the estimate
(CLIA) Waiver Applications,’’ you may proposed collection of information, below. The recommendation for quick
either send a fax request to 301–443– including the validity of the reference instructions is a new
8818 to receive a hard copy of the methodology and assumptions used; (3) information collection which FDA is
document, or send an e-mail request to ways to enhance the quality, utility, and submitting to OMB for review. Quick
gwa@cdrh.fda.gov to receive a hard copy clarity of the information to be reference instructions are a short
or an electronic copy. Please use the collected; and (4) ways to minimize the version of the instructions that are
document number (1171) to identify the burden of the collection of information written in simple language and that can
guidance you are requesting. on respondents, including through the be posted. The guidance also notes that
Persons interested in obtaining a copy use of automated collection techniques, waived tests remain subject to
of the draft guidance may also do so by when appropriate, and other forms of applicable reporting and recordkeeping
using the Internet. CDRH maintains an information technology. requirements under 21 CFR part 803.
entry on the Internet for easy access to Title: Recommendations for CLIA The burden associated with this
information including text, graphics, Waiver Applications provision is approved under OMB
and files that may be downloaded to a Description: Congress passed the control number 0910–0437.
personal computer with Internet access. CLIA (Public Law 100–578) in 1988 to
Updated on a regular basis, the CDRH establish quality standards for all Respondents to this collection of
home page includes device safety alerts, laboratory testing. The purpose was to information are manufacturers of in
Federal Register reprints, information ensure the accuracy, reliability, and vitro diagnostic devices.
on premarket submissions (including timeliness of patient test results FDA estimates the burden of this
lists of approved applications and regardless of where the test took place. collection as follows.

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Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 53233


No. of Re- Annual Frequency per Operating and Mainte-
Total Annual Responses Hours per response Total Hours
spondents Response nance Costs

40 1 40 780 31,200 $5,500

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


No. of Rec- Annual Frequency per Operating and Mainte-
Total Annual Records Hours per Record Total Hours
ordkeepers Recordkeeping nance Costs

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

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

Based on previous years’ experience DEPARTMENT OF HEALTH AND by mail by calling CBER at 1–800–835–
with CLIA waiver applications, FDA HUMAN SERVICES 4709 or 301–827–1800. Submit written
expects 40 manufacturers to apply for comments on the draft guidance to the
one CLIA waiver per year. The annual Food and Drug Administration Division of Dockets Management (HFA–
reporting burden to respondents is [Docket No. 2005D–0334] 305), Food and Drug Administration,
estimated to be 31,200 hours, and 5630 Fishers Lane, rm. 1061, Rockville,
recordkeeping burdens for respondents Draft Guidance for Industry on the MD 20852. Submit electronic comments
is estimated to be 112,000 hours. FDA Pediatric Research Equity Act; to http://www.fda.gov/dockets/
based the reporting and recordkeeping Availability ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic
burden on an agency analysis of AGENCY: Food and Drug Administration, access to the draft guidance document.
premarket submissions with clinical HHS. FOR FURTHER INFORMATION CONTACT:
trials similar to the waived laboratory ACTION: Notice. Grace Carmouze, Center for Drug
tests. Evaluation and Research (HFD–
SUMMARY: The Food and Drug
The total operating and maintenance 950), Food and Drug
Administration (FDA) is announcing the
cost associated with the implementation Administration,5600 Fishers Lane,
availability of a draft guidance for
of this draft guidance is estimated to be industry entitled ‘‘How to Comply with Rockville, MD 20857, 301–594–
$66,200. The cost consists of specimen the Pediatric Research Equity Act.’’ This 2041, or
collection for the clinical study Leonard Wilson, Center for Biologics
draft guidance provides
(estimated at $23,500); laboratory Evaluation and Research (HFM–25),
recommendations on how to interpret
supplies, reference testing and study Food and Drug Administration,
the requirements of the Pediatric
oversight (estimated $26,700); shipping 1401 Rockville Pike, suite 200N
Research Equity Act (PREA), which
and office supplies (estimated $6,000); Rockville, MD 20852–1448, 301–
requires pediatric studies of certain
and educational materials, including 827–0373.
drugs and biological products to ensure
quick reference instructions ($10,000). SUPPLEMENTARY INFORMATION:
that those products that are likely to be
commonly used in children or that I. Background
V. Comments
represent a meaningful therapeutic FDA is announcing the availability of
Interested persons may submit to the benefit over existing treatments contain a draft guidance for industry entitled
Division of Dockets Management (see adequate pediatric labeling for approved ‘‘How to Comply with the Pediatric
ADDRESSES) written or electronic indications. Research Equity Act.’’ On December 3,
comments regarding this document. DATES: Submit written or electronic 2003, the Pediatric Research Equity Act
Submit a single copy of electronic comments on the draft guidance by was signed into law. PREA amends the
comments or two paper copies of any November 7, 2005. General comments Federal Food, Drug, and Cosmetic Act
mailed comments, except that on agency guidance documents are (the act) by adding section 505B (21
individuals may submit one paper copy. welcome at any time. U.S.C. 355B). In PREA, Congress
Comments are to be identified with the ADDRESSES: Submit written requests for codified many of the elements of the
docket number found in brackets in the single copies of the draft guidance to the Pediatric Rule, a final rule issued by
heading of this document. Received Division of Drug Information (HFD– FDA on December 2, 1998 (63 FR
comments may be seen in the Division 240), Center for Drug Evaluation and 66632), and suspended by court order
Research, Food and Drug on October 17, 2002. Association of
of Dockets Management between 9 a.m.
Administration, 5600 Fishers Lane, American Physicians, and Surgeons,
and 4 p.m., Monday through Friday.
Rockville, MD 20857; or to the Office of Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C.
Dated: August 31, 2005. Communication, Training, and 2002). Specifically, PREA, in adding
Jeffrey Shuren, Manufacturers Assistance (HFM–40), section 505B(a) of the act, requires all
Assistant Commissioner for Policy. Center for Biologics Evaluation and applications (or supplements to an
[FR Doc. 05–17732 Filed 9–1–05; 4:00 pm] Research, Food and Drug application) submitted under section
Administration, 1401 Rockville Pike, 505 of the act (21 U.S.C. 355) or section
Rockville, MD 20852–1448. Send one 351 of the Public Health Service Act
self-addressed adhesive label to assist (PHS Act) (42 U.S.C. 262) for a new
that office in processing your requests. active ingredient, new indication, new
The draft guidance may also be obtained dosage form, new dosing regimen, or

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