Determination that CYANOCOBALAMIN INJECTION, 1 Milligram per Milliliter in a 10 Milliliter Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 14002-14003 [2017-05246]

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Correction Determination that CYANOCOBALAMIN INJECTION, 1 Milligram per Milliliter in a 10 Milliliter Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices infestation; malignancy of pancreas or bowel; or folic acid deficiency. In a letter dated December 21, 2016, Fresenius notified FDA that CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter vial, was discontinued over 30 years ago, and Fresenius had concluded that the drug was discontinued for reasons other than safety or effectiveness. Fresenius also conveyed that they currently manufacture and market a 1 milliliter multiple dose vial of the 1 milligram per milliliter concentration. John R. Rapoza submitted a citizen petition dated June 16, 2016 (Docket No. FDA–2016–P–1676), under 21 CFR 10.30, requesting that the Agency determine whether CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter vial, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter vial, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter vial, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter vial, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will list CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter vial, 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. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also 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 VerDate Sep<11>2014 17:12 Mar 15, 2017 Jkt 241001 advise ANDA applicants to submit such labeling. Dated: March 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–05246 Filed 3–15–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Product-Specific Guidances for Rifaximin; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic rifaximin oral tablets entitled ‘‘Draft Guidance on Rifaximin.’’ The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for rifaximin oral tablets. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 15, 2017. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 14003 identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2007–D–0369 for ‘‘Draft Guidance on Rifaximin.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ will be publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)]
[Notices]
[Pages 14002-14003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05246]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-1676]


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: Notice.

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

SUMMARY: 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 
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

[[Page 14003]]

infestation; malignancy of pancreas or bowel; or folic acid deficiency.
    In a letter dated December 21, 2016, Fresenius notified FDA that 
CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter 
vial, was discontinued over 30 years ago, and Fresenius had concluded 
that the drug was discontinued for reasons other than safety or 
effectiveness. Fresenius also conveyed that they currently manufacture 
and market a 1 milliliter multiple dose vial of the 1 milligram per 
milliliter concentration.
    John R. Rapoza submitted a citizen petition dated June 16, 2016 
(Docket No. FDA-2016-P-1676), under 21 CFR 10.30, requesting that the 
Agency determine whether CYANOCOBALAMIN INJECTION, 1 milligram per 
milliliter in a 10 milliliter vial, was withdrawn from sale for reasons 
of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that CYANOCOBALAMIN INJECTION, 1 milligram per 
milliliter in a 10 milliliter vial, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that CYANOCOBALAMIN INJECTION, 1 milligram per 
milliliter in a 10 milliliter vial, was withdrawn for reasons of safety 
or effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of CYANOCOBALAMIN INJECTION, 1 milligram per 
milliliter in a 10 milliliter vial, from sale. We have also 
independently evaluated relevant literature and data for possible 
postmarketing adverse events. We have reviewed the available evidence 
and determined that this drug product was not withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will list CYANOCOBALAMIN INJECTION, 1 
milligram per milliliter in a 10 milliliter vial, 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. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to this drug product. Additional ANDAs for 
this drug product may also 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.

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05246 Filed 3-15-17; 8:45 am]
BILLING CODE 4164-01-P

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