Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction, 32838-32839 [2017-15003]
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32838
Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
whose name appears on the label of a
licensed biological product. In table 1,
the number of respondents is based on
the estimated number of manufacturers
that are subject to those regulations or
that submitted the required information
to the Center for Biologics Evaluation
and Research and Center for Drugs
Evaluation and Research, FDA, in fiscal
year (FY) 2016. Based on information
obtained from the FDA’s database
system, there were 93 manufacturers of
biological products. This number
excludes those manufacturers who
produce Whole Blood, components of
Whole Blood, or in-vitro diagnostic
licensed products, because of the
exemption under § 600.80(m). The total
annual responses are based on the
number of submissions received by FDA
in FY 2016. There were an estimated
125,371 15-day Alert reports, 180,580
periodic reports, and 677 lot
distribution reports submitted to FDA.
The number of 15-day Alert reports for
postmarketing studies under § 600.80(e)
is included in the total number of 15day Alert reports. FDA received 81
requests from 40 manufacturers for
waivers under § 600.90 (including
§§ 600.80(h)(2) and 600.81(b)(2)), of
which 79 were granted. The hours per
response are based on FDA experience.
The burden hours required to complete
the MedWatch Form (Form FDA 3500A)
for § 600.80(c)(1), (e), and (f) are
reported under OMB control number
0910–0291.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
600.80(c)(1), 600.80(d), and 600.80(e); postmarketing 15day Alert reports ...............................................................
600.82; notification of discontinuance or interruption in
manufacturing ...................................................................
600.80(c)(2); periodic adverse experience reports ..............
600.81 Distribution Reports .................................................
600.80(h)(2), 600.81(b)(2), and 600.90; waiver requests ...
Total ..............................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
93
1,348.07
125,371
1
125,371
18
93
93
40
1.61
1,941.72
7.28
2.03
29
180,580
677
81
2
28
1
1
58
5,056,240
677
81
........................
........................
........................
........................
5,182,427
are no capital costs or operating and maintenance costs associated with this collection information.
In table 2 the number of respondents
is based on the number of
manufacturers subject to those
regulations. Based on information
obtained from FDA’s database system,
there were 263 licensed manufacturers
of biological products in FY 2016.
However, the number of recordkeepers
listed for § 600.12(a) through (e)
excluding (b)(2) is estimated to be 114.
This number excludes manufacturers of
blood and blood components because
their burden hours for recordkeeping
have been reported under § 606.160 in
OMB control number 0910–0116. The
total annual records is based on the
annual average of lots released in FY
2016 (7,198), number of recalls made
(575), and total number of adverse
experience reports received (305,951) in
FY 2016. The hours per record are based
on FDA experience.
FDA estimates the burden of this
recordkeeping as follows:
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeper
(in hours)
Total hours
600.12; 2 maintenance of records ........................................
600.12(b)(2); recall records .................................................
600.80(c)(1) and 600.80(k) ..................................................
114
263
93
63.14
2.19
3,289.79
7,198
575
305,951
32
24
1
230,336
13,800
305,951
Total ..............................................................................
........................
........................
........................
........................
550,087
1 There
sradovich on DSK3GMQ082PROD with NOTICES
2 The
are no capital costs or operating and maintenance costs associated with this collection of information.
recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12.
The burden for this information
collection has changed since the last
OMB approval. Because of an increase
in the number of AER reports we have
received during the past 3 years, we
have increased our reporting and
recordkeeping burden estimates.
Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–15004 Filed 7–17–17; 8:45 am]
[Docket No. FDA–2016–N–0002]
BILLING CODE 4164–01–P
Food and Drug Administration
Hospira, Inc. et al.; Withdrawal of
Approval of 44 New Drug Applications
and 158 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:31 Jul 17, 2017
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of October 4, 2016 (81 FR
68427). The document announced the
withdrawal of approval of 44 new drug
applications and 158 abbreviated new
drug applications (ANDAs) from
multiple applicants, effective November
3, 2016. The document inadvertently
announced withdrawal of approval for
the following two ANDAs: ANDA
074123 for Pindolol Tablets, held by
G&W Laboratories, Inc., 111 Coolidge
St., South Plainfield, NJ 07080; and
ANDA 080828 for Hydrocortisone
Acetate Ophthalmic Ointment USP,
held by Fera Pharmaceuticals LLC, 134
Birch Hill Rd., Locust Valley, NY 11560.
FDA confirms that the approval of
ANDAs 074123 and 080828 is still in
effect.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Tuesday, October 4,
2016, appearing on page 68427 in FR
Doc. 2016–23893, the following
corrections are made:
1. On page 68429, in table 1, the entry
for ANDA 074123 is removed.
2. On page 68431, in table 1, the entry
for ANDA 080828 is removed.
Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15003 Filed 7–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2011–N–0017]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary National
Retail Food Regulatory Program
Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
VerDate Sep<11>2014
17:47 Jul 17, 2017
Jkt 241001
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 17,
2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0621. Also
include the FDA docket number found
in brackets in the heading of this
document.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Voluntary National Retail Food
Regulatory Program Standards
OMB Control Number 0910–0621—
Extension
The Voluntary National Retail Food
Regulatory Program Standards (the
Program Standards) define nine
essential elements of an effective
regulatory program for retail food
establishments, establish basic quality
control criteria for each element, and
provide a means of recognition for the
State, local, territorial, tribal and
Federal regulatory programs that meet
the Program Standards. The program
elements addressed by the Program
Standards are as follows: (1) Regulatory
foundation; (2) trained regulatory staff;
(3) inspection program based on Hazard
Analysis and Critical Control Point
(HACCP) principles; (4) uniform
inspection program, (5) foodborne
illness and food defense preparedness
and response; (6) compliance and
enforcement; (7) industry and
community relations; (8) program
support and resources; and (9) program
assessment. Each standard includes a
list of records needed to document
conformance with the standard (referred
to in the Program Standards document
as ‘‘quality records’’) and has one or
more corresponding forms and
worksheets to facilitate the collection of
information needed to assess the retail
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32839
food regulatory program against that
standard. The respondents are State,
local, territorial, tribal, and potentially
other Federal regulatory Agencies.
Regulatory Agencies may use existing
available records or may choose to
develop and use alternate forms and
worksheets that capture the same
information.
In the course of their normal
activities, State, local, territorial, tribal,
and Federal regulatory Agencies already
collect and keep on file many of the
records needed as quality records to
document compliance with each of the
Program Standards. Although the detail
and format in which this information is
collected and recorded may vary by
jurisdiction, records that are kept as a
usual and customary part of normal
Agency activities include inspection
records, written quality assurance
procedures, records of quality assurance
checks, staff training certificates and
other training records, a log or database
of food-related illness or injury
complaints, records of investigations
resulting from such complaints, an
inventory of inspection equipment,
records of outside audits, and records of
outreach efforts (e.g., meeting agendas
and minutes, documentation of food
safety education activities). No new
recordkeeping burden is associated with
these existing records, which are
already a part of usual and customary
program recordkeeping activities by
State, local, territorial, tribal and
Federal regulatory Agencies, and which
can serve as quality records under the
Program Standards.
In April 2016, the Conference for
Food Protection (CFP) recommended
that FDA make a change in Program
Standard #4—Uniform Inspection
Program, more specifically to change
Program Standard #4’s Program SelfAssessment and Verification Audit
Form. Once changes have been
incorporated into the 2017 version, it
will be available on FDA’s Web site.
With this change, in order to achieve
conformance to Program Standard #4,
jurisdictions must achieve an overall
inspection program performance rating
for 20 elements as opposed to 10
elements that were previously required.
The previous 10 elements had several
criteria under one program element. The
change to 20 elements allows the
Standard to clearly delineate out each
criterion individually rather than having
several criteria under one program
element. This streamlines and clarifies
the process in meeting the standard. As
a result, the assessment review of each
inspector’s work will now be required
for three joint inspections as opposed to
the previously required two.
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Agencies
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32838-32839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15003]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0002]
Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug
Applications and 158 Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
[[Page 32839]]
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of October 4, 2016 (81 FR 68427).
The document announced the withdrawal of approval of 44 new drug
applications and 158 abbreviated new drug applications (ANDAs) from
multiple applicants, effective November 3, 2016. The document
inadvertently announced withdrawal of approval for the following two
ANDAs: ANDA 074123 for Pindolol Tablets, held by G&W Laboratories,
Inc., 111 Coolidge St., South Plainfield, NJ 07080; and ANDA 080828 for
Hydrocortisone Acetate Ophthalmic Ointment USP, held by Fera
Pharmaceuticals LLC, 134 Birch Hill Rd., Locust Valley, NY 11560. FDA
confirms that the approval of ANDAs 074123 and 080828 is still in
effect.
FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, October
4, 2016, appearing on page 68427 in FR Doc. 2016-23893, the following
corrections are made:
1. On page 68429, in table 1, the entry for ANDA 074123 is removed.
2. On page 68431, in table 1, the entry for ANDA 080828 is removed.
Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15003 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P