Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cosmetic Labeling Regulations, 27574-27575 [E7-9436]

Download as PDF 27574 ACTION: Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices Notice. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance: SUPPLEMENTARY INFORMATION: SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization (42 CFR 493.17) Fax written comments on the collection of information by June 15, 2007. DATES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974. All comments should be identified with the OMB Control Number 0910–NEW and the title ‘‘Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization.’’ Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. A draft guidance document entitled ‘‘Guidance for Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization’’ (CLIA) was released for comment on August 14, 2000. The document describes procedures FDA will use to assign the complexity category to a device. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In this way, no additional burden is incurred by the manufacturer since the labeling (including operating instructions) is included in the 510(k) or premarket approval (PMA). In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is when a manufacturer requests that FDA assign CLIA categorization to a previously cleared device that has changed names since the original CLIA categorization. Another example is when a device is exempt from premarket review. In such cases, the guidance recommends that manufacturers provide FDA with a copy of the package insert for the device and a cover letter indicating why the manufacturer is requesting a categorization (e.g., name change exempt from 510(k) review). The draft guidance recommends that in the correspondence to FDA the manufacturer should identify the product code and classification as well as reference to the original 510(k) when this is available. A previous 60-day notice that published August 14, 2000 (65 FR 49582), announced the availability of a draft guidance and did not include a Paperwork Analysis Section. This 60day notice for public comment supersedes that notice and is correcting that error. In the Federal Register of February 14, 2007 (72 FR 7043), FDA published a 60-day notice soliciting public comment on the proposed collection of information requirements. In response to that notice, no comments were received. The likely respondents for this collection are Investigational New Drug Application sponsors. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 42 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Total Operating & Maintenance 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. cprice-sewell on PROD1PC66 with NOTICES The number of respondents is approximately 60. On average, each respondent will request categorizations (independent of a 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $50. This includes the cost of copying and mailing copies of package inserts and a cover letter, which includes a statement of the reason for the request and reference to the original 510(k) numbers, including regulation numbers and product codes. DEPARTMENT OF HEALTH AND HUMAN SERVICES Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Food and Drug Administration FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. Dated: May 10, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–9435 Filed 5–15–07; 8:45 am] HHS. BILLING CODE 4160–01–S VerDate Aug<31>2005 15:27 May 15, 2007 Jkt 211001 [Docket No. 2005N–0494] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cosmetic Labeling Regulations AGENCY: ACTION: Food and Drug Administration, Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Cosmetic Labeling Regulations’’ has been approved by the Office of PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 In the Federal Register of December 4, 2006 (71 FR 70411), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned SUPPLEMENTARY INFORMATION: E:\FR\FM\16MYN1.SGM 16MYN1 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices OMB control number 0910–0599. The approval expires on May 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Dated: May 10, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–9436 Filed 5–15–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006P–0372] Determination That MEPRON (Atovaquone) Tablets, 250 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. cprice-sewell on PROD1PC66 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined that MEPRON (atovaquone) tablets, 250 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for atovaquone tablets, 250 mg. FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug Evaluation and Research (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal VerDate Aug<31>2005 15:27 May 15, 2007 Jkt 211001 Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.161(a)(1) (21 CFR 314.162)). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. MEPRON (atovaquone) tablets, 250 mg, are the subject of approved NDA 20–259 held by GlaxoSmithKline (Glaxo). MEPRON (atovaquone) tablets, 250 mg, approved November 25, 1992, are indicated for the prevention of Pneumocystis carinii pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole (TMPSMX). Glaxo ceased marketing MEPRON (atovaquone) tablets, 250 mg, in 1995. Lachman Consultant Services, Inc., submitted a citizen petition dated September 7, 2006 (Docket No. 2006P– 0372/CP1), under 21 CFR 10.30, requesting that the agency determine, as described in § 314.161, whether MEPRON (atovaquone) tablets, 250 mg, were withdrawn from sale for reasons of safety or effectiveness.The agency has determined that Glaxo’s MEPRON (atovaquone) tablets, 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that MEPRON tablets, 250 mg, were withdrawn from sale as a result of safety or effectiveness concerns. FDA has independently evaluated relevant literature and data for adverse event reports and has found no information that would indicate this product was withdrawn for reasons of safety or effectiveness. After considering the citizen petition and reviewing its records, FDA determines that, for the reasons outlined in this notice, Glaxo’s MEPRON (atovaquone) tablets, 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will list MEPRON (atovaquone) tablets, 250 mg, in the ‘‘Discontinued PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 27575 Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety oreffectiveness. ANDAs that refer to MEPRON (atovaquone) tablets, 250 mg, may be approved by the agency as long as they meet all relevant legal and regulatory requirements for the approval of ANDAs. Dated: May 10, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–9348 Filed 5–15–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0112] Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.’’ This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications. Applicants are encouraged to use this guidance to design cancer clinical trials and to discuss protocols with the agency. This guidance provides background information and discusses general regulatory principles. Additional companion guidances will follow and will focus on endpoints for specific cancer types (e.g., lung cancer, colon cancer) to support drug approval or labeling claims. This guidance, and the subsequent indication-specific guidances, should speed the development and improve the quality of protocols submitted to the agency to support anticancer effectiveness claims. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and E:\FR\FM\16MYN1.SGM 16MYN1

Agencies

[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Notices]
[Pages 27574-27575]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0494]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Cosmetic Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Cosmetic Labeling Regulations'' 
has been approved by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 4, 2006 
(71 FR 70411), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 44 
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned

[[Page 27575]]

OMB control number 0910-0599. The approval expires on May 31, 2010. A 
copy of the supporting statement for this information collection is 
available on the Internet at https://www.fda.gov/ohrms/dockets.

    Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9436 Filed 5-15-07; 8:45 am]
BILLING CODE 4160-01-S

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