82 FR 14002 - Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 50 (March 16, 2017)

Page Range		14002-14002
FR Document		2017-05247

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.

Federal Register, Volume 82 Issue 50 (Thursday, March 16, 2017)

[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)]
[Notices]
[Page 14002]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].
    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

14002 Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices

Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hrs)
respondent (in hrs)

Law Enforcement Officers ................ Pre-Enrollment Confirmation Email .. 333 1 1/60 6
Law Enforcement Officers ................ Biographical Information .................. 333 1 3/60 17
Law Enforcement Officers ................ Consent form .................................... 333 1 5/60 28
Law Enforcement Officers ................ Traditional anthropometric measure- 333 1 30/60 167
ments.
Law Enforcement Officers ................ 2D and 3D scans ............................. 333 1 30/60 167
Total ........................................... ........................................................... ........................ ........................ ........................ 385

Leroy A. Richardson, 10000 New Hampshire Ave., Silver must, with certain exceptions, show that
Chief, Information Collection Review Office, Spring, MD 20903.’’ the drug for which they are seeking
Office of Scientific Integrity, Office of the Dated: March 13, 2017. approval contains the same active
Associate Director for Science, Office of the ingredient in the same strength, dosage
Director, Centers for Disease Control and Leslie Kux,
Associate Commissioner for Policy.
form, and route of administration as the
Prevention. ‘‘listed drug,’’ which is a version of the
[FR Doc. 2017–05265 Filed 3–15–17; 8:45 am] [FR Doc. 2017–05247 Filed 3–15–17; 8:45 am]
drug that was previously approved.
BILLING CODE 4164–01–P
BILLING CODE 4163–18–P ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
drug application (NDA).
HUMAN SERVICES HUMAN SERVICES
The 1984 amendments include what
Food and Drug Administration Food and Drug Administration is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
[Docket No. FDA–N–2016–4198] [Docket No. FDA–2016–P–1676] 355(j)(7)), which requires FDA to
Determination that publish a list of all approved drugs.
Public Meeting on Patient-Focused FDA publishes this list as part of the
Drug Development for Sarcopenia; CYANOCOBALAMIN INJECTION, 1
Milligram per Milliliter in a 10 Milliliter ‘‘Approved Drug Products With
Request for Comments; Correction Therapeutic Equivalence Evaluations,’’
Vial, Was Not Withdrawn From Sale for
AGENCY: Food and Drug Administration, Reasons of Safety or Effectiveness which is known generally as the
HHS. ‘‘Orange Book.’’ Under FDA regulations,
ACTION: Notice; correction. AGENCY: Food and Drug Administration, drugs are removed from the list if the
HHS. Agency withdraws or suspends
SUMMARY: The Food and Drug ACTION: Notice. approval of the drug’s NDA or ANDA
Administration is correcting a notice for reasons of safety or effectiveness or
entitled ‘‘Public Meeting on Patient- SUMMARY: The Food and Drug if FDA determines that the listed drug
Focused Drug Development for Administration (FDA or Agency) has was withdrawn from sale for reasons of
Sarcopenia’’ that appeared in the determined that CYANOCOBALAMIN safety or effectiveness (21 CFR 314.162).
Federal Register of December 14, 2016 INJECTION, 1 milligram per milliliter in A person may petition the Agency to
(81 FR 90361). The document a 10 milliliter vial, was not withdrawn determine, or the Agency may
announced a public meeting and an from sale for reasons of safety or determine on its own initiative, whether
opportunity for public comment on effectiveness. This determination means a listed drug was withdrawn from sale
Patient-Focused Drug Development for that FDA will not begin procedures to for reasons of safety or effectiveness.
Sarcopenia. The location of the meeting withdraw approval of abbreviated new This determination may be made at any
has changed and this document drug applications (ANDAs) that refer to time after the drug has been withdrawn
provides the updated meeting location. this drug product, and it will allow FDA from sale, but must be made prior to
to continue to approve ANDAs that refer approving an ANDA that refers to the
FOR FURTHER INFORMATION CONTACT:
to the product as long as they meet listed drug (21 CFR 314.161). FDA may
Meghana Chalasani, Center for Drug
relevant legal and regulatory not approve an ANDA that does not
Evaluation and Research, Food and
requirements. refer to a listed drug.
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, FOR FURTHER INFORMATION CONTACT: CYANOCOBALAMIN INJECTION, 1
Silver Spring, MD 20993–0002, 240– Elizabeth Trentacost, Center for Drug milligram per milliliter in a 10 milliliter
402–6525, FAX: 301–847–8443, Evaluation and Research, Food and vial, is the subject of ANDA 080557,
Meghana.Chalasani@fda.hhs.gov. Drug Administration, 10903 New held by Fresenius Kabi USA (Fresenius),
In the Federal Register of Wednesday, Hampshire Ave., Bldg. 51, Rm. 6219, and initially approved on June 20, 1973.
December 14, 2016, in FR Doc. 2016– Silver Spring, MD 20993–0002, 240– CYANOCOBALAMIN INJECTION is
29998, the following correction is made: 402–7736. indicated for vitamin B12 deficiencies
1. On page 90361, in the second SUPPLEMENTARY INFORMATION: In 1984, due to malabsorption that may be
mstockstill on DSK3G9T082PROD with NOTICES

column, in the first sentence of the Congress enacted the Drug Price associated with the following
ADDRESSES section, ‘‘FDA White Oak Competition and Patent Term conditions: Addisonian (pernicious)
Campus, 10903 New Hampshire Ave., Restoration Act of 1984 (Pub. L. 98–417) anemia; gastrointestinal pathology,
Bldg. 31 Conference Center, the Great (the 1984 amendments), which dysfunction, or surgery, including
Room, (Rm. 1503), Silver Spring, MD authorized the approval of duplicate gluten enteropathy or sprue, small
20993–0002.’’ is corrected to read versions of drug products under an bowel bacterial overgrowth, and total or
‘‘Tommy Douglas Conference Center, ANDA procedure. ANDA applicants partial gastrectomy; fish tapeworm

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Document Created: 2017-03-16 02:18:42
Document Modified: 2017-03-16 02:18:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; correction.
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, [email protected]
FR Citation		82 FR 14002

82 FR 14002 - Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 50 (March 16, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration