Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments; Correction, 14002 [2017-05247]

Download as PDF 14002 Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices Type of respondents Law Law Law Law Enforcement Enforcement Enforcement Enforcement Officers Officers Officers Officers Number of respondents Form name ................ ................ ................ ................ Average burden per response (in hrs) Number of responses per respondent Total burden (in hrs) 333 333 333 333 1 1 1 1 1/60 3/60 5/60 30/60 6 17 28 167 Law Enforcement Officers ................ Pre-Enrollment Confirmation Email .. Biographical Information .................. Consent form .................................... Traditional anthropometric measurements. 2D and 3D scans ............................. 333 1 30/60 167 Total ........................................... ........................................................... ........................ ........................ ........................ 385 Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. Dated: March 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–05265 Filed 3–15–17; 8:45 am] [FR Doc. 2017–05247 Filed 3–15–17; 8:45 am] BILLING CODE 4163–18–P BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–N–2016–4198] [Docket No. FDA–2016–P–1676] Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments; Correction Determination that CYANOCOBALAMIN INJECTION, 1 Milligram per Milliliter in a 10 Milliliter Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: AGENCY: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Public Meeting on PatientFocused Drug Development for Sarcopenia’’ that appeared in the Federal Register of December 14, 2016 (81 FR 90361). The document announced a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Sarcopenia. The location of the meeting has changed and this document provides the updated meeting location. FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993–0002, 240– 402–6525, FAX: 301–847–8443, Meghana.Chalasani@fda.hhs.gov. In the Federal Register of Wednesday, December 14, 2016, in FR Doc. 2016– 29998, the following correction is made: 1. On page 90361, in the second column, in the first sentence of the ADDRESSES section, ‘‘FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room, (Rm. 1503), Silver Spring, MD 20993–0002.’’ is corrected to read ‘‘Tommy Douglas Conference Center, mstockstill on DSK3G9T082PROD with NOTICES 17:12 Mar 15, 2017 Food and Drug Administration, HHS. SUMMARY: VerDate Sep<11>2014 10000 New Hampshire Ave., Silver Spring, MD 20903.’’ Jkt 241001 ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter vial, was 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Elizabeth Trentacost, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993–0002, 240– 402–7736. 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 SUMMARY: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength, dosage form, and route of administration 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 known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are 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). 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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer to a listed drug. CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter vial, is the subject of ANDA 080557, held by Fresenius Kabi USA (Fresenius), and initially approved on June 20, 1973. CYANOCOBALAMIN INJECTION is indicated for vitamin B12 deficiencies due to malabsorption that may be associated with the following conditions: Addisonian (pernicious) anemia; gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, and total or partial gastrectomy; fish tapeworm E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)]
[Notices]
[Page 14002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05247]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-N-2016-4198]


Public Meeting on Patient-Focused Drug Development for 
Sarcopenia; Request for Comments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Public Meeting on Patient-Focused Drug Development for 
Sarcopenia'' that appeared in the Federal Register of December 14, 2016 
(81 FR 90361). The document announced a public meeting and an 
opportunity for public comment on Patient-Focused Drug Development for 
Sarcopenia. The location of the meeting has changed and this document 
provides the updated meeting location.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, FAX: 301-847-8443, Meghana.Chalasani@fda.hhs.gov.
    In the Federal Register of Wednesday, December 14, 2016, in FR Doc. 
2016-29998, the following correction is made:
    1. On page 90361, in the second column, in the first sentence of 
the ADDRESSES section, ``FDA White Oak Campus, 10903 New Hampshire 
Ave., Bldg. 31 Conference Center, the Great Room, (Rm. 1503), Silver 
Spring, MD 20993-0002.'' is corrected to read ``Tommy Douglas 
Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903.''

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05247 Filed 3-15-17; 8:45 am]
 BILLING CODE 4164-01-P
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