Advisory Committee Renewals, 50658-50659 [2014-20017]
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50658
Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Activity/section
Number of
disclosures
per
respondent
Average
burden
per
disclosure
Total
annual
disclosures
Total hours
Notifying immediate previous source of the article of
food under section 417(d)(7)(C)(i) of the FD&C Act
(mandatory reporters only).
Notifying immediate subsequent recipient of the article of food under section 417(d)(7)(C)(ii) of the
FD&C Act (mandatory reporters only).
1,200
1
1,200
0.6 (36 minutes) ....
720
1,200
1
1,200
0.6 (36 minutes) ....
720
Total ......................................................................
........................
........................
........................
...............................
2,880
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Third Party Disclosure
We estimate that approximately 1,200
reportable food events with mandatory
reporters will occur annually. Based on
past FDA experiences, we estimate that
we could receive 200 to 1,200
‘‘reportable’’ food reports annually from
200 to 1,200 mandatory and voluntary
users of the electronic reporting system.
We utilized the upper-bound estimate of
1,200 for these calculations.
We estimate that notifying the
immediate previous source(s) will take
0.6 hours per reportable food and
notifying the immediate subsequent
recipient(s) will take 0.6 hours per
reportable food. We also estimate that it
will take 0.6 hours for the immediate
previous source and/or the immediate
subsequent recipient to also notify their
immediate previous source(s) and/or
immediate subsequent recipient(s). The
Agency bases its estimate on its
experience with mandatory and
voluntary reports submitted to FDA.
Although it is not mandatory under
FDAAA section 1005 that responsible
persons notify the sources and
recipients of instances of reportable
food, for purposes of the burden
estimate we are assuming FDA would
exercise its authority and require such
notifications in all such instances for
mandatory reporters. This notification
burden will not affect voluntary
reporters of reportable food events.
Therefore, we estimate that the total
burden of notifying the immediate
previous source(s) and immediate
subsequent recipient(s) under section
417(d)(6)(B)(i), (d)(6)(B)(ii), (d)(7)(C)(i),
and (d)(7)(C)(ii) of the FD&C Act for
1,200 reportable foods will be 2,880
hours annually (1,200 × 0.6 hours) +
(1,200 × 0.6 hours) + (1,200 × 0.6 hours)
+ (1,200 × 0.6 hours). This annual
burden is shown in table 1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/section
Maintenance of
tion 417(g) of
Maintenance of
tion 417(g) of
Number of
records per
recordkeeping
Total
annual
records 2
Average
burden per
record
Total hours
reportable food records under secthe FD&C Act—Mandatory reports.
reportable food records under secthe FD&C Act—Voluntary reports.
1,200
1
1,200
0.25 (15 minutes) ..
300
600
1
600
0.25 (15 minutes) ..
150
Total ..................................................................
..........................
..........................
........................
...............................
450
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
purposes of estimating number of records and hours per record, a ‘‘record’’ means all records kept for an individual reportable food by
the responsible party or a voluntary reporter.
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2 For
Recordkeeping
As noted previously, section 417(g) of
the FD&C Act requires that responsible
persons maintain records related to
reportable foods reports and
notifications under section 417 of the
FD&C Act for a period of 2 years. Based
on past FDA experiences, we estimate
that each mandatory report and its
associated notifications will require 30
minutes of recordkeeping for the 2-year
period, or 15 minutes per record per
year. The annual recordkeeping burden
for mandatory reportable food reports
and their associated notifications is thus
estimated to be 300 hours (1,200 × 0.25
hours).
We do not expect that records will
always be kept in relation to voluntary
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reportable food reports. Therefore, we
estimate that records will be kept for
600 of the 1,200 voluntary reports we
expect to receive annually. The
recordkeeping burden associated with
voluntary reports is thus estimated to be
150 hours annually (600 × 0.25 hours).
The estimated total annual
recordkeeping burden will be 450 hours
annually (1,200 × 0.25 hours) + (600 ×
0.25 hours). This annual burden is
shown in table 2.
Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–20021 Filed 8–22–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Advisory Committee Renewals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
renewal of certain FDA advisory
committees by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
SUMMARY:
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Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
charters of the committees listed in the
following table for an additional 2 years
beyond charter expiration date. The new
charters will be in effect until the dates
following table unless the
Commissioner formally determines that
renewal is in the public interest.
of expiration listed in the following
table.
Authority for these committees
will expire on the dates indicated in the
DATES:
Name of committee
Date of expiration
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology ...........................
Gastrointestinal Drugs Advisory Committee ................................................................................
Bone, Reproductive and Urologic Drugs Advisory Committee (formerly Reproductive Health
Drugs Advisory Committee).
Arthritis Advisory Committee .......................................................................................................
Pharmacy Compounding Advisory Committee ............................................................................
Anesthetic and Analgesic Drugs Advisory Committee ................................................................
Blood Products Advisory Committee ...........................................................................................
Pulmonary-Allergy Drugs Advisory Committee ...........................................................................
Drug Safety and Risk Management Advisory Committee ...........................................................
Science Advisory Board to the National Center for Toxicological Research ..............................
Peripheral and Central Nervous System Drugs Advisory Committee .........................................
Psychopharmacologic Drugs Advisory Committee ......................................................................
Transmissible and Spongiform Encephalopathies Advisory Committee .....................................
Science Board to the Food and Drug Administration ..................................................................
Allergenic Products Advisory Committee.
FOR FURTHER INFORMATION CONTACT:
Michael Ortwerth, Director, Advisory
Committee Oversight and Management
Staff, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–443–0572
or 1–800–741–8138. For further
information related to FDA advisory
committees please visit us at: https://
www.fda.gov/AdvisoryCommittees/
default.htm.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–20017 Filed 8–22–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–P–0549]
emcdonald on DSK67QTVN1PROD with NOTICES
Determination That SULAR
(Nisoldipine) Extended-Release
Tablets, 10 Milligrams, 20 Milligrams,
25.5 Milligrams, 30 Milligrams, and 40
Milligrams, 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 SULAR (nisoldipine) extendedrelease tablets, 10 milligrams (mg), 20
SUMMARY:
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January 22, 2016.
March 3, 2016.
March 23, 2016.
April 5, 2016.
April 25, 2016.
May 1, 2016.
May 13, 2016.
May 30, 2016.
May 31, 2016.
June 2, 2016.
June 4, 2016.
June 4, 2016.
June 9, 2016.
June 26, 2016.
July 9, 2016.
mg, 25.5 mg, 30 mg, and 40 mg, 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
approve ANDAs for nisoldipine
extended-release tablets, 10 mg, 20 mg,
25.5 mg, 30 mg, and 40 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Emily Gebbia, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217,
Silver Spring, MD 20993–0002, 240–
402–0980.
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 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
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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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
SULAR (nisoldipine) extended-release
tablets, 10 mg, 20 mg, 25.5 mg, 30 mg,
and 40 mg, is the subject of NDA 20–
356, held by Shionogi Inc., and initially
approved on February 2, 1995. SULAR
is indicated for the treatment of
hypertension.
SULAR (nisoldipine) extended-release
tablets, 10 mg, 20 mg, 25.5 mg, 30 mg,
and 40 mg, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. Emcure
Pharmaceuticals USA, Inc., submitted a
citizen petition dated April 28, 2014
(Docket No. FDA–2014–P–0549), under
21 CFR 10.30, requesting that the
Agency determine whether SULAR
(nisoldipine) extended-release tablets,
25.5 mg, was withdrawn from sale for
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]]>Agencies
[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50658-50659]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20017]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Advisory Committee Renewals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of certain FDA advisory committees by the Commissioner of Food
and Drugs (the Commissioner). The Commissioner has determined that it
is in the public interest to renew the
[[Page 50659]]
charters of the committees listed in the following table for an
additional 2 years beyond charter expiration date. The new charters
will be in effect until the dates of expiration listed in the following
table.
DATES: Authority for these committees will expire on the dates
indicated in the following table unless the Commissioner formally
determines that renewal is in the public interest.
------------------------------------------------------------------------
Name of committee Date of expiration
------------------------------------------------------------------------
Advisory Committee for Pharmaceutical January 22, 2016.
Science and Clinical Pharmacology.
Gastrointestinal Drugs Advisory Committee. March 3, 2016.
Bone, Reproductive and Urologic Drugs March 23, 2016.
Advisory Committee (formerly Reproductive
Health Drugs Advisory Committee).
April 5, 2016.
Arthritis Advisory Committee.............. April 25, 2016.
Pharmacy Compounding Advisory Committee... May 1, 2016.
Anesthetic and Analgesic Drugs Advisory May 13, 2016.
Committee.
Blood Products Advisory Committee......... May 30, 2016.
Pulmonary-Allergy Drugs Advisory Committee May 31, 2016.
Drug Safety and Risk Management Advisory June 2, 2016.
Committee.
Science Advisory Board to the National June 4, 2016.
Center for Toxicological Research.
Peripheral and Central Nervous System June 4, 2016.
Drugs Advisory Committee.
Psychopharmacologic Drugs Advisory June 9, 2016.
Committee.
Transmissible and Spongiform June 26, 2016.
Encephalopathies Advisory Committee.
Science Board to the Food and Drug July 9, 2016.
Administration.
Allergenic Products Advisory Committee....
------------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Director, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-443-0572 or
1-800-741-8138. For further information related to FDA advisory
committees please visit us at: https://www.fda.gov/AdvisoryCommittees/default.htm.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20017 Filed 8-22-14; 8:45 am]
BILLING CODE 4164-01-P
