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27574 Federal Register / Vol. 72, No.

94 / Wednesday, May 16, 2007 / Notices

ACTION: Notice. SUPPLEMENTARY INFORMATION: In Another example is when a device is


compliance with 44 U.S.C. 3507, FDA exempt from premarket review. In such
SUMMARY: The Food and Drug has submitted the following proposed cases, the guidance recommends that
Administration (FDA) is announcing collection of information to OMB for manufacturers provide FDA with a copy
that a proposed collection of review and clearance: of the package insert for the device and
information has been submitted to the a cover letter indicating why the
Administrative Procedures for the
Office of Management and Budget manufacturer is requesting a
Clinical Laboratory Improvement
(OMB) for review and clearance under categorization (e.g., name change
Amendments of 1988 Categorization (42
the Paperwork Reduction Act of 1995. exempt from 510(k) review). The draft
CFR 493.17)
guidance recommends that in the
DATES: Fax written comments on the A draft guidance document entitled correspondence to FDA the
collection of information by June 15, ‘‘Guidance for Administrative manufacturer should identify the
2007. Procedures for Clinical Laboratory product code and classification as well
Improvement Amendments of 1988 as reference to the original 510(k) when
ADDRESSES: To ensure that comments on
Categorization’’ (CLIA) was released for this is available.
the information collection are received,
comment on August 14, 2000. The A previous 60-day notice that
OMB recommends that written
document describes procedures FDA published August 14, 2000 (65 FR
comments be faxed to the Office of
will use to assign the complexity 49582), announced the availability of a
Information and Regulatory Affairs,
category to a device. Typically, FDA draft guidance and did not include a
OMB, Attn: FDA Desk Officer, FAX:
assigns complexity categorizations to Paperwork Analysis Section. This 60-
202–395–6974. All comments should be
devices at the time of clearance or day notice for public comment
identified with the OMB Control
approval of the device. In this way, no supersedes that notice and is correcting
Number 0910–NEW and the title
additional burden is incurred by the that error.
‘‘Administrative Procedures for the
manufacturer since the labeling In the Federal Register of February
Clinical Laboratory Improvement
(including operating instructions) is 14, 2007 (72 FR 7043), FDA published
Amendments of 1988 Categorization.’’
included in the 510(k) or premarket a 60-day notice soliciting public
Also include the FDA docket number
approval (PMA). In some cases, comment on the proposed collection of
found in brackets in the heading of this
however, a manufacturer may request information requirements. In response
document.
CLIA categorization even if FDA is not to that notice, no comments were
FOR FURTHER INFORMATION CONTACT: simultaneously reviewing a 510(k) or received.
Denver Presley, Jr., Office of the Chief PMA. One example is when a The likely respondents for this
Information Officer (HFA–250), Food manufacturer requests that FDA assign collection are Investigational New Drug
and Drug Administration, 5600 Fishers CLIA categorization to a previously Application sponsors.
Lane, Rockville, MD 20857, 301–827– cleared device that has changed names FDA estimates the burden of this
1472. since the original CLIA categorization. collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


Total Operating &
No. of Annual Frequency Total Annual Hours per
42 CFR Section Total Hours Maintenance
Respondents per Response Responses Response Costs

493.17 60 15 900 1 900 $45,000

Total 60 15 900 1 900 $45,000


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

The number of respondents is DEPARTMENT OF HEALTH AND Management and Budget (OMB) under
approximately 60. On average, each HUMAN SERVICES the Paperwork Reduction Act of 1995.
respondent will request categorizations FOR FURTHER INFORMATION CONTACT:
(independent of a 510(k) or PMA) 15 Food and Drug Administration
Jonna Capezzuto, Office of the Chief
times per year. The cost, not including Information Officer (HFA–250), Food
personnel, is estimated at $50. This [Docket No. 2005N–0494] and Drug Administration, 5600 Fishers
includes the cost of copying and mailing Lane, Rockville, MD 20857, 301–827–
copies of package inserts and a cover Agency Information Collection
Activities; Announcement of Office of 4659.
letter, which includes a statement of the
reason for the request and reference to Management and Budget Approval; SUPPLEMENTARY INFORMATION: In the
Cosmetic Labeling Regulations Federal Register of December 4, 2006
the original 510(k) numbers, including
regulation numbers and product codes. (71 FR 70411), the agency announced
AGENCY: Food and Drug Administration, that the proposed information collection
Dated: May 10, 2007. HHS. had been submitted to OMB for review
Jeffrey Shuren, ACTION: Notice. and clearance under 44 U.S.C. 3507. An
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Assistant Commissioner for Policy. agency may not conduct or sponsor, and
[FR Doc. E7–9435 Filed 5–15–07; 8:45 am] SUMMARY: The Food and Drug a person is not required to respond to,
BILLING CODE 4160–01–S Administration (FDA) is announcing a collection of information unless it
that a collection of information entitled displays a currently valid OMB control
‘‘Cosmetic Labeling Regulations’’ has number. OMB has now approved the
been approved by the Office of information collection and has assigned

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Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices 27575

OMB control number 0910–0599. The Food, Drug, and Cosmetic Act (the act) Drug Product List’’ section of the Orange
approval expires on May 31, 2010. A (21 U.S.C. 355(j)(7)), which requires Book. The ‘‘Discontinued Drug Product
copy of the supporting statement for this FDA to publish a list of all approved List’’ delineates, among other items,
information collection is available on drugs. FDA publishes this list as part of drug products that have been
the Internet at http://www.fda.gov/ the ‘‘Approved Drug Products With discontinued from marketing for reasons
ohrms/dockets. Therapeutic Equivalence Evaluations,’’ other than safety oreffectiveness.
Dated: May 10, 2007. which is generally known as the ANDAs that refer to MEPRON
‘‘Orange Book.’’ Under FDA regulations, (atovaquone) tablets, 250 mg, may be
Jeffrey Shuren,
drugs are withdrawn from the list if the approved by the agency as long as they
Assistant Commissioner for Policy.
agency withdraws or suspends approval meet all relevant legal and regulatory
[FR Doc. E7–9436 Filed 5–15–07; 8:45 am] of the drug’s NDA or ANDA for reasons requirements for the approval of
BILLING CODE 4160–01–S of safety or effectiveness or if FDA ANDAs.
determines that the listed drug was Dated: May 10, 2007.
withdrawn from sale for reasons of
DEPARTMENT OF HEALTH AND Jeffrey Shuren,
safety or effectiveness (§ 314.161(a)(1)
HUMAN SERVICES (21 CFR 314.162)). Assistant Commissioner for Policy.
Under § 314.161(a)(1) (21 CFR [FR Doc. E7–9348 Filed 5–15–07; 8:45 am]
Food and Drug Administration 314.161(a)(1)), the agency must BILLING CODE 4160–01–S
[Docket No. 2006P–0372] determine whether a listed drug was
withdrawn from sale for reasons of
Determination That MEPRON safety or effectiveness before an ANDA DEPARTMENT OF HEALTH AND
(Atovaquone) Tablets, 250 milligrams, that refers to that listed drug may be HUMAN SERVICES
Were Not Withdrawn From Sale for approved. FDA may not approve an
Reasons of Safety or Effectiveness ANDA that does not refer to a listed Food and Drug Administration

AGENCY: Food and Drug Administration, drug. [Docket No. 2005D–0112]


MEPRON (atovaquone) tablets, 250
HHS. Guidance for Industry on Clinical Trial
mg, are the subject of approved NDA
ACTION: Notice. 20–259 held by GlaxoSmithKline Endpoints for the Approval of Cancer
SUMMARY: The Food and Drug (Glaxo). MEPRON (atovaquone) tablets, Drugs and Biologics; Availability
Administration (FDA) has determined 250 mg, approved November 25, 1992, AGENCY: Food and Drug Administration,
that MEPRON (atovaquone) tablets, 250 are indicated for the prevention of HHS.
milligrams (mg), were not withdrawn Pneumocystis carinii pneumonia in
patients who are intolerant to ACTION: Notice.
from sale for reasons of safety or
effectiveness. This determination will trimethoprim-sulfamethoxazole (TMP- SUMMARY: The Food and Drug
allow FDA to approve abbreviated new SMX). Glaxo ceased marketing Administration (FDA) is announcing the
drug applications (ANDAs) for MEPRON (atovaquone) tablets, 250 mg, availability of a guidance for industry
atovaquone tablets, 250 mg. in 1995. entitled ‘‘Clinical Trial Endpoints for
Lachman Consultant Services, Inc., the Approval of Cancer Drugs and
FOR FURTHER INFORMATION CONTACT:
submitted a citizen petition dated Biologics.’’ This guidance provides
Christine F. Rogers, Center for Drug September 7, 2006 (Docket No. 2006P–
Evaluation and Research (HFD–7), Food recommendations to applicants on
0372/CP1), under 21 CFR 10.30, endpoints for cancer clinical trials
and Drug Administration, 5600 Fishers requesting that the agency determine, as
Lane, Rockville, MD 20857, 301–594– submitted to FDA to support
described in § 314.161, whether effectiveness claims in new drug
2041. MEPRON (atovaquone) tablets, 250 mg, applications, biologics license
SUPPLEMENTARY INFORMATION: In 1984, were withdrawn from sale for reasons of applications, or supplemental
Congress enacted the Drug Price safety or effectiveness.The agency has applications. Applicants are encouraged
Competition and Patent Term determined that Glaxo’s MEPRON to use this guidance to design cancer
Restoration Act of 1984 (Public Law 98– (atovaquone) tablets, 250 mg, were not clinical trials and to discuss protocols
417) (the 1984 amendments), which withdrawn from sale for reasons of
with the agency. This guidance provides
authorized the approval of duplicate safety or effectiveness. The petitioner
background information and discusses
versions of drug products approved has identified no data or other
general regulatory principles.
under an ANDA procedure. ANDA information suggesting that MEPRON
Additional companion guidances will
sponsors must, with certain exceptions, tablets, 250 mg, were withdrawn from
follow and will focus on endpoints for
show that the drug for which they are sale as a result of safety or effectiveness
specific cancer types (e.g., lung cancer,
seeking approval contains the same concerns. FDA has independently
colon cancer) to support drug approval
active ingredient in the same strength evaluated relevant literature and data
or labeling claims. This guidance, and
and dosage form as the ‘‘listed drug,’’ for adverse event reports and has found
the subsequent indication-specific
which is a version of the drug that was no information that would indicate this
guidances, should speed the
previously approved. Sponsors of product was withdrawn for reasons of
development and improve the quality of
ANDAs do not have to repeat the safety or effectiveness.
After considering the citizen petition protocols submitted to the agency to
extensive clinical testing otherwise
and reviewing its records, FDA support anticancer effectiveness claims.
necessary to gain approval of a new
determines that, for the reasons outlined DATES: Submit written or electronic
drug application (NDA). The only
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clinical data required in an ANDA are in this notice, Glaxo’s MEPRON comments on agency guidances at any
data to show that the drug that is the (atovaquone) tablets, 250 mg, were not time.
subject of the ANDA is bioequivalent to withdrawn from sale for reasons of ADDRESSES: Submit written requests for
the listed drug. safety or effectiveness. Accordingly, the single copies of this guidance to the
The 1984 amendments include what agency will list MEPRON (atovaquone) Division of Drug Information (HFD–
is now section 505(j)(7) of the Federal tablets, 250 mg, in the ‘‘Discontinued 240), Center for Drug Evaluation and

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