Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments; Correction, 14002 [2017-05247]
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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]
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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Vial, Was Not Withdrawn From Sale for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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
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