82 FR 32838 - Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 136 (July 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 136 (July 18, 2017)
| Page Range | 32838-32839 | |
| FR Document | 2017-15003 |
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)] [Notices] [Pages 32838-32839] From the Federal Register Online [www.thefederalregister.org] [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
![32838 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
whose name appears on the label of a produce Whole Blood, components of requests from 40 manufacturers for
licensed biological product. In table 1, Whole Blood, or in-vitro diagnostic waivers under § 600.90 (including
the number of respondents is based on licensed products, because of the §§ 600.80(h)(2) and 600.81(b)(2)), of
the estimated number of manufacturers exemption under § 600.80(m). The total which 79 were granted. The hours per
that are subject to those regulations or annual responses are based on the response are based on FDA experience.
that submitted the required information number of submissions received by FDA The burden hours required to complete
to the Center for Biologics Evaluation in FY 2016. There were an estimated the MedWatch Form (Form FDA 3500A)
and Research and Center for Drugs 125,371 15-day Alert reports, 180,580 for § 600.80(c)(1), (e), and (f) are
Evaluation and Research, FDA, in fiscal periodic reports, and 677 lot reported under OMB control number
year (FY) 2016. Based on information distribution reports submitted to FDA.
0910–0291.
obtained from the FDA’s database The number of 15-day Alert reports for
system, there were 93 manufacturers of postmarketing studies under § 600.80(e) FDA estimates the burden of this
biological products. This number is included in the total number of 15- collection of information as follows:
excludes those manufacturers who day Alert reports. FDA received 81
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section responses per Total hours
respondents responses response
respondent (in hours)
600.80(c)(1), 600.80(d), and 600.80(e); postmarketing 15-
day Alert reports ............................................................... 93 1,348.07 125,371 1 125,371
600.82; notification of discontinuance or interruption in
manufacturing ................................................................... 18 1.61 29 2 58
600.80(c)(2); periodic adverse experience reports .............. 93 1,941.72 180,580 28 5,056,240
600.81 Distribution Reports ................................................. 93 7.28 677 1 677
600.80(h)(2), 600.81(b)(2), and 600.90; waiver requests ... 40 2.03 81 1 81
Total .............................................................................. ........................ ........................ ........................ ........................ 5,182,427
1 There are no capital costs or operating and maintenance costs associated with this collection information.
In table 2 the number of respondents listed for § 600.12(a) through (e) annual average of lots released in FY
is based on the number of excluding (b)(2) is estimated to be 114. 2016 (7,198), number of recalls made
manufacturers subject to those This number excludes manufacturers of (575), and total number of adverse
regulations. Based on information blood and blood components because experience reports received (305,951) in
obtained from FDA’s database system, their burden hours for recordkeeping FY 2016. The hours per record are based
there were 263 licensed manufacturers have been reported under § 606.160 in on FDA experience.
of biological products in FY 2016. OMB control number 0910–0116. The FDA estimates the burden of this
However, the number of recordkeepers total annual records is based on the recordkeeping as follows:
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section records per Total hours
recordkeepers records recordkeeper
recordkeeper (in hours)
600.12; 2 maintenance of records ........................................ 114 63.14 7,198 32 230,336
600.12(b)(2); recall records ................................................. 263 2.19 575 24 13,800
600.80(c)(1) and 600.80(k) .................................................. 93 3,289.79 305,951 1 305,951
Total .............................................................................. ........................ ........................ ........................ ........................ 550,087
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12.
The burden for this information Dated: July 12, 2017. DEPARTMENT OF HEALTH AND
collection has changed since the last Anna K. Abram, HUMAN SERVICES
OMB approval. Because of an increase Deputy Commissioner for Policy, Planning,
in the number of AER reports we have Legislation, and Analysis. Food and Drug Administration
received during the past 3 years, we [FR Doc. 2017–15004 Filed 7–17–17; 8:45 am] [Docket No. FDA–2016–N–0002]
sradovich on DSK3GMQ082PROD with NOTICES
have increased our reporting and BILLING CODE 4164–01–P
recordkeeping burden estimates. 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.
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![Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices 32839
ACTION: Notice; correction. information has been submitted to the food regulatory program against that
Office of Management and Budget standard. The respondents are State,
SUMMARY: The Food and Drug (OMB) for review and clearance under local, territorial, tribal, and potentially
Administration (FDA) is correcting a the Paperwork Reduction Act of 1995. other Federal regulatory Agencies.
notice that appeared in the Federal Regulatory Agencies may use existing
DATES: Fax written comments on the
Register of October 4, 2016 (81 FR available records or may choose to
collection of information by August 17,
68427). The document announced the develop and use alternate forms and
2017.
withdrawal of approval of 44 new drug worksheets that capture the same
ADDRESSES: To ensure that comments on
applications and 158 abbreviated new information.
drug applications (ANDAs) from the information collection are received,
In the course of their normal
multiple applicants, effective November OMB recommends that written
activities, State, local, territorial, tribal,
3, 2016. The document inadvertently comments be faxed to the Office of
and Federal regulatory Agencies already
announced withdrawal of approval for Information and Regulatory Affairs,
collect and keep on file many of the
the following two ANDAs: ANDA OMB, Attn: FDA Desk Officer, FAX:
records needed as quality records to
074123 for Pindolol Tablets, held by 202–395–7285, or emailed to oira_
document compliance with each of the
G&W Laboratories, Inc., 111 Coolidge submission@omb.eop.gov. All
Program Standards. Although the detail
St., South Plainfield, NJ 07080; and comments should be identified with the and format in which this information is
ANDA 080828 for Hydrocortisone OMB control number 0910–0621. Also collected and recorded may vary by
Acetate Ophthalmic Ointment USP, include the FDA docket number found jurisdiction, records that are kept as a
held by Fera Pharmaceuticals LLC, 134 in brackets in the heading of this usual and customary part of normal
Birch Hill Rd., Locust Valley, NY 11560. document. Agency activities include inspection
FDA confirms that the approval of FOR FURTHER INFORMATION CONTACT: Ila records, written quality assurance
ANDAs 074123 and 080828 is still in S. Mizrachi, Office of Operations, Food procedures, records of quality assurance
effect. and Drug Administration, Three White checks, staff training certificates and
FOR FURTHER INFORMATION CONTACT:
Flint North, 10A63, 11601 Landsdown other training records, a log or database
Florine Purdie, Center for Drug St., North Bethesda, MD 20852, 301– of food-related illness or injury
Evaluation and Research, Food and 796–7726. complaints, records of investigations
Drug Administration, 10903 New SUPPLEMENTARY INFORMATION: In resulting from such complaints, an
Hampshire Ave., Bldg. 51, Rm. 6248, compliance with 44 U.S.C. 3507, FDA inventory of inspection equipment,
has submitted the following proposed records of outside audits, and records of
Silver Spring, MD 20993–0002, 301–
collection of information to OMB for outreach efforts (e.g., meeting agendas
796–3601.
review and clearance. and minutes, documentation of food
SUPPLEMENTARY INFORMATION: In the safety education activities). No new
Federal Register of Tuesday, October 4, Voluntary National Retail Food recordkeeping burden is associated with
2016, appearing on page 68427 in FR Regulatory Program Standards these existing records, which are
Doc. 2016–23893, the following already a part of usual and customary
corrections are made: OMB Control Number 0910–0621—
Extension program recordkeeping activities by
1. On page 68429, in table 1, the entry State, local, territorial, tribal and
for ANDA 074123 is removed. The Voluntary National Retail Food Federal regulatory Agencies, and which
2. On page 68431, in table 1, the entry Regulatory Program Standards (the can serve as quality records under the
for ANDA 080828 is removed. Program Standards) define nine Program Standards.
Dated: July 12, 2017. essential elements of an effective In April 2016, the Conference for
Anna K. Abram,
regulatory program for retail food Food Protection (CFP) recommended
establishments, establish basic quality that FDA make a change in Program
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
control criteria for each element, and Standard #4—Uniform Inspection
provide a means of recognition for the Program, more specifically to change
[FR Doc. 2017–15003 Filed 7–17–17; 8:45 am]
State, local, territorial, tribal and Program Standard #4’s Program Self-
BILLING CODE 4164–01–P
Federal regulatory programs that meet Assessment and Verification Audit
the Program Standards. The program Form. Once changes have been
elements addressed by the Program incorporated into the 2017 version, it
DEPARTMENT OF HEALTH AND
Standards are as follows: (1) Regulatory will be available on FDA’s Web site.
HUMAN SERVICES
foundation; (2) trained regulatory staff; With this change, in order to achieve
Food and Drug Administration (3) inspection program based on Hazard conformance to Program Standard #4,
Analysis and Critical Control Point jurisdictions must achieve an overall
[Docket No. FDA–2011–N–0017] (HACCP) principles; (4) uniform inspection program performance rating
inspection program, (5) foodborne for 20 elements as opposed to 10
Agency Information Collection
illness and food defense preparedness elements that were previously required.
Activities; Submission for Office of
and response; (6) compliance and The previous 10 elements had several
Management and Budget Review;
enforcement; (7) industry and criteria under one program element. The
Comment Request; Voluntary National
community relations; (8) program change to 20 elements allows the
Retail Food Regulatory Program
support and resources; and (9) program Standard to clearly delineate out each
Standards
assessment. Each standard includes a criterion individually rather than having
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: Food and Drug Administration, list of records needed to document several criteria under one program
HHS. conformance with the standard (referred element. This streamlines and clarifies
ACTION: Notice. to in the Program Standards document the process in meeting the standard. As
as ‘‘quality records’’) and has one or a result, the assessment review of each
SUMMARY: The Food and Drug more corresponding forms and inspector’s work will now be required
Administration (FDA) is announcing worksheets to facilitate the collection of for three joint inspections as opposed to
that a proposed collection of information needed to assess the retail the previously required two.
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Document Created: 2018-10-24 11:25:35
Document Modified: 2018-10-24 11:25:35
| 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 | 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. | |
| FR Citation | 82 FR 32838 |
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