Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements; Correction, 64806-64807 [2014-25910]

Download as PDF 64806 Federal Register / Vol. 79, No. 211 / Friday, October 31, 2014 / Notices title ‘‘Application for Participation in the Food and Drug Administration Commissioner’s Fellowship Program.’’ Also include the FDA docket number found in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: 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: Application for Participation in the FDA Commissioner’s Fellowship Program; (OMB Control Number 0910— New) Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code authorize Federal Agencies to rate applicants for Federal jobs. Collecting applications for the Commissioner’s Fellowship Program will allow FDA’s Office of the Commissioner to easily and efficiently elicit and review information from students and health care professionals who are interested in becoming involved in FDA-wide activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with FDA. In the Federal Register of August 4, 2014 (79 FR 45196), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited and, therefore, will not be discussed in this document. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity/5 U.S.C. section Number of responses per respondent Total annual responses Average burden per response Total hours 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 ....... 600 1 600 1.33 798 Total .............................................................................. ........................ ........................ ........................ ........................ 798 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA based these estimates on the number of inquiries that have been received concerning the program and the number of requests for application forms over the past 5 years. Dated: October 27, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–25893 Filed 10–30–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0801] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements; Correction AGENCY: Food and Drug Administration, HHS. ACTION: document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. In this document, we correct some errors that appeared in the notice. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. In FR Doc. 2014–24293, appearing on page 61643 in the Federal Register of October 14, 2014 (79 FR 61643), we make the following correction: On page 61644, replace table 1 with the following table: SUPPLEMENTARY INFORMATION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 14, 2014. The SUMMARY: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents asabaliauskas on DSK5VPTVN1PROD with NOTICES 21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours 1.101(d) (Non-Tobacco) (CBER) ......................................... 1,101(d) (Non-Tobacco) (CDER) ......................................... 1.101(d) (Non-Tobacco) (CDRH) ......................................... 5 5 63 193 180 130 965 900 8,190 15 15 15 14,475 13,500 122,850 Total 2 ............................................................................ ........................ ........................ ........................ ........................ 150,825 1 There are no capital costs or operating and maintenance costs associated with this collection of information. to a clerical error, the reporting burden for ‘‘Exports: Notification and Recordkeeping Requirements’’, which published on July 3, 2014 (79 FR 38036), was incorrect. Table 1 of this document contains the correct reporting burden for this collection. 2 Due VerDate Sep<11>2014 20:52 Oct 30, 2014 Jkt 235001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 Federal Register / Vol. 79, No. 211 / Friday, October 31, 2014 / Notices Dated: October 27, 2014. Leslie Kux, Assistant Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2014–25910 Filed 10–30–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1577] Determination That TOPICORT (Desoximetasone) Cream and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. SUMMARY: Amy Hopkins, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993–0002, 301– 796–5418, Amy.Hopkins@fda.hhs.gov. 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 approved 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 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 generally known as the ‘‘Orange Book.’’ Under FDA regulations, 64807 a drug is removed 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 (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table in this document are no longer being marketed. (As requested by the applicant, FDA withdrew approval of NDA 020611 for DOVONEX (calcipotriene) Solution and NDA 020239 for KYTRIL (granisetron hydrochloride) in the Federal Register of July 19, 2013 (78 FR 43210)). Application No. Drug Applicant NDA 017856 .............. TOPICORT (desoximetasone) Cream; Topical 0.25% ........ NDA 020239 .............. KYTRIL (granisetron HCl) Injectable; Injection, Equivalent to (EQ) 0.1 milligram (mg) Base/milliliter (mL); EQ 1 mg Base/mL; EQ 3 mg Base/mL; EQ 4 mg Base/4 mL. DOVONEX (calcipotriene) Solution; Topical, 0.005% ......... LUMIGAN (bimatoprost) Solution/Drops; Ophthalmic, 0.03%. LYBREL (ethinyl estradiol; levonorgestrel) Tablet; Oral, 0.02 mg/0.09 mg. Ketorolac Tromethamine Injectable; Injection, 15 mg/mL; 30 mg/mL. Ketorolac Tromethamine Injectable; Injection, 30 mg/mL ... Taro Pharmaceuticals North America Inc., 5 Skyline Dr., Hawthorne, NY 10532. Hoffmann La Roche Inc., 340 Kingsland St., Nutley, NJ 07110. NDA 020611 .............. NDA 021275 .............. NDA 021864 .............. ANDA 075222 ............ asabaliauskas on DSK5VPTVN1PROD with NOTICES ANDA 075228 ............ FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued VerDate Sep<11>2014 18:51 Oct 30, 2014 Jkt 235001 Leo Pharma Inc., 1 Sylvan Way, Parsippany, NJ 07054. Allergan Inc., 2525 Dupont Dr., Irvine, CA 92623. Wyeth Pharmaceuticals Inc., P.O. Box 8299, Philadelphia, PA 19101. Bedford Laboratories Inc., 300 Northfield Rd., Bedford, OH 44146. Do. from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet PO 00000 Frm 00067 Fmt 4703 Sfmt 9990 current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: October 27, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–25911 Filed 10–30–14; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\31OCN1.SGM 31OCN1

Agencies

[Federal Register Volume 79, Number 211 (Friday, October 31, 2014)]
[Notices]
[Pages 64806-64807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25910]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0801]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Exports: Notification 
and Recordkeeping Requirements; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of October 14, 2014. The document 
announced that a proposed collection of information had been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995. In this document, we correct 
some errors that appeared in the notice.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. 2014-24293, appearing on page 
61643 in the Federal Register of October 14, 2014 (79 FR 61643), we 
make the following correction: On page 61644, replace table 1 with the 
following table:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
1.101(d) (Non-Tobacco) (CBER)...               5             193             965              15          14,475
1,101(d) (Non-Tobacco) (CDER)...               5             180             900              15          13,500
1.101(d) (Non-Tobacco) (CDRH)...              63             130           8,190              15         122,850
                                 -------------------------------------------------------------------------------
    Total \2\...................  ..............  ..............  ..............  ..............         150,825
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Due to a clerical error, the reporting burden for ``Exports: Notification and Recordkeeping Requirements'',
  which published on July 3, 2014 (79 FR 38036), was incorrect. Table 1 of this document contains the correct
  reporting burden for this collection.



[[Page 64807]]

    Dated: October 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25910 Filed 10-30-14; 8:45 am]
BILLING CODE 4164-01-P