Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 28045 [2011-11743]

Download as PDF Federal Register / Vol. 76, No. 93 / Friday, May 13, 2011 / Notices Dated: May 9, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2011–11744 Filed 5–12–11; 8:45 am] BILLING CODE 4160–01–P [Docket No. FDA–2011–P–0128] DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination That XIBROM (Bromfenac Ophthalmic Solution) 0.09% Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Food and Drug Administration AGENCY: [Docket No. FDA–2010–N–0355] ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. In the Federal Register of September 27, 2010 (75 FR 59266), 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 OMB control number 0910–0606. The approval expires on February 28, 2014. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. mstockstill on DSKH9S0YB1PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: May 4, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–11743 Filed 5–12–11; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 17:22 May 12, 2011 Jkt 223001 Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) has determined that XIBROM (bromfenac ophthalmic solution) 0.09% was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for bromfenac ophthalmic solution 0.09% if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6368, Silver Spring, MD 20993–0002, 301– 796–3522. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants 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. ANDA applicants 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 Food, Drug, and Cosmetic 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 known generally as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA SUMMARY: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 28045 for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. XIBROM (bromfenac ophthalmic solution) 0.09% is the subject of NDA 021664 held by ISTA Pharmaceuticals, Inc. (Ista), approved March 24, 2005. XIBROM is a topical nonsteroidal antiinflammatory drug for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. In a citizen petition dated March 1, 2011, and in a letter dated March 3, 2011, Ista informed FDA that it had discontinued shipping XIBROM (bromfenac ophthalmic solution) 0.09% as of February 28, 2011. Ista took the position that XIBROM (bromfenac ophthalmic solution) 0.09% had been discontinued for safety reasons. After considering the citizen petition and reviewing Agency records, FDA determined under § 314.161 that XIBROM (bromfenac ophthalmic solution) 0.09% was not withdrawn for reasons of safety or effectiveness. We described the basis for this determination in our letter response to Ista’s citizen petition (available on https://www.regulations.gov under Docket No. FDA–2011–P–0128). Accordingly, the Agency will continue to list XIBROM (bromfenac ophthalmic solution) 0.09% in the ‘‘Discontinued 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 or effectiveness. ANDAs that refer to XIBROM (bromfenac ophthalmic solution) 0.09% may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. E:\FR\FM\13MYN1.SGM 13MYN1

Agencies

[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Notices]
[Page 28045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0355]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Current Good Manufacturing Practice 
in Manufacturing, Packaging, Labeling, or Holding Operations for 
Dietary Supplements

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 ``Current Good Manufacturing 
Practice in Manufacturing, Packaging, Labeling, or Holding Operations 
for Dietary Supplements'' has been approved by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3793.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 27, 
2010 (75 FR 59266), 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 OMB control number 0910-0606. 
The approval expires on February 28, 2014. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11743 Filed 5-12-11; 8:45 am]
BILLING CODE 4160-01-P

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