81 FR 60705 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 171 (September 2, 2016)

Page Range		60705-60706
FR Document		2016-21128

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 81 Issue 171 (Friday, September 2, 2016)

[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60705-60706]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0450]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Abbreviated New 
Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of 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 October 
3, 2016.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0669. 
Also

[[Page 60706]]

include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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.

Abbreviated New Animal Drug Applications--Sections (b)(2) and (n)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and 
(n)(1))--OMB Control Number 0910-0669--Extension

    Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act), any person may file an abbreviated new animal drug 
application (ANADA) seeking approval of a generic copy of an approved 
new animal drug. The information required to be submitted as part of an 
ANADA is described in section 512(n)(1) of the FD&C Act. Among other 
things, an ANADA is required to contain information to show that the 
proposed generic drug is bioequivalent to, and has the same labeling 
as, the approved new animal drug. We use the information submitted, 
among other things, to assess bioequivalence to the originally approved 
drug and thus, the safety and effectiveness of the generic new animal 
drug. We allow applicants to submit a complete ANADA or to submit 
information in support of an ANADA for phased review. Applicants may 
submit Form FDA 356v with a complete ANADA or a phased review 
submission to ensure efficient and accurate processing of information.
    In the Federal Register of May 11, 2016 (81 FR 29273), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                               Number of
FD&C Act sections 512(b)(2) and                   Number of    responses      Total       Average       Total
             (n)(1)                 FDA Form     respondents      per         annual    burden  per     hours
                                                               respondent   responses     response
----------------------------------------------------------------------------------------------------------------
ANADA..........................  356v..........           18            1           18          159        2,862
Phased Review with               356v..........            3            5           15         31.8          477
 Administrative ANADA.
                                                ----------------------------------------------------------------
    Total......................  ..............  ...........  ...........  ...........  ...........        3,339
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimates on our experience with ANADA submissions and 
requests for phased review. We estimate that we will receive 21 ANADA 
submissions per year over the next three years and that three of those 
submissions will request phased review. We estimate that each applicant 
that uses the phased review process will have approximately five phased 
reviews per application. We estimate that an applicant will take 
approximately 159 hours to prepare either an ANADA or the estimated 5 
ANADA phased review submissions and the administrative ANADA.

    Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21128 Filed 9-1-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices 60705

other aspect of this collection of comply with this requirement, CMS is complaint category. Specifically, the
information, including any of the publishing this notice that summarizes information collection revisions clarify
following subjects: The necessity and the following proposed collection(s) of the ‘‘Identify the HIPAA Non-Privacy/
utility of the proposed information information for public comment: Security complaint category’’ section of
collection for the proper performance of 1. Type of Information Collection the complaint form. In this section,
the agency’s functions; the accuracy of Request: Extension of a currently complainants are given an opportunity
the estimated burden; ways to enhance approved collection; Title of to check the ‘‘Unique Identifiers’’ and
the quality, utility, and clarity of the Information Collection: Examination ‘‘Operating Rules’’ option to
information to be collected; and the use and Treatment for Emergency Medical additionally categorize the type of
of automated collection techniques or Conditions and Women in Labor; Use: HIPAA complaint being filed. The
other forms of information technology to Pursuant to regulation sections 488.18, revised form now includes an option for
minimize the information collection 489.20 and 489.24, during Medicare identifying Unique Identifier and
burden. surveys of hospitals and State agencies Operating Rules complaints. It also
CMS will review hospital records for requests email information about filed
DATES: Comments on the collection(s) of lists of on-call physicians, and will
information must be received by the against entities, if available. Form
review and obtain the information Number: CMS–10148 (OMB control
OMB desk officer by October 3, 2016. which must be recorded on hospital number: 0938–0948); Frequency:
ADDRESSES: When commenting on the medical records for individuals with Occasionally; Affected Public:
proposed information collections, emergency medical conditions and Individuals; Number of Respondents:
please reference the document identifier women in labor, and the emergency 500; Total Annual Responses: 500; Total
or OMB control number. To be assured department reporting information Annual Hours: 500. (For policy
consideration, comments and Medicare participating hospitals and questions regarding this collection
recommendations must be received by Medicare State survey agencies must contact Cecily Austin at 410–786–0895.)
the OMB desk officer via one of the pass on to CMS. Additionally, CMS will
following transmissions: OMB, Office of use the QIO Report assessing whether Dated: August 30, 2016.
Information and Regulatory Affairs, an individual had an emergency William N. Parham, III,
Attention: CMS Desk Officer, Fax condition and whether the individual Director, Paperwork Reduction Staff, Office
Number: (202) 395–5806 OR, Email: was stabilized to determine whether to of Strategic Operations and Regulatory
OIRA_submission@omb.eop.gov. impose a CMP or physician exclusion Affairs.
To obtain copies of a supporting sanctions. Without such information, [FR Doc. 2016–21201 Filed 9–1–16; 8:45 am]
statement and any related forms for the CMS will be unable to make the hospital BILLING CODE 4120–01–P
proposed collection(s) summarized in emergency services compliance
this notice, you may make your request determinations that Congress expects
using one of following: CMS to make under sections 1154, 1866 DEPARTMENT OF HEALTH AND
1. Access CMS’ Web site address at and 1867 of the Act. Form Number: HUMAN SERVICES
http://www.cms.hhs.gov/ CMS–R–142 (OMB control number:
0938–0667); Frequency: Occasionally; Food and Drug Administration
PaperworkReductionActof1995.
2. Email your request, including your Affected Public: Private Sector; Number [Docket No. FDA–2013–N–0450]
address, phone number, OMB number, of Respondents: 6,149; Total Annual
and CMS document identifier, to Responses: 6,149; Total Annual Hours: Agency Information Collection
Paperwork@cms.hhs.gov. 1. (For policy questions regarding this Activities; Submission for Office of
3. Call the Reports Clearance Office at collection contact Renate Dombrowski Management and Budget Review;
(410) 786–1326. at 410–786–4645.) Comment Request; Abbreviated New
FOR FURTHER INFORMATION CONTACT:
2. Type of Information Collection Animal Drug Applications
Reports Clearance Office at (410) 786– Request: Reinstatement with change of a
AGENCY: Food and Drug Administration,
1326. previously approved collection; Title of
Information Collection: HIPAA HHS.
SUPPLEMENTARY INFORMATION: Under the Administrative Simplification ACTION: Notice.
Paperwork Reduction Act of 1995 (PRA) Complaint Form; Use: The Health
(44 U.S.C. 3501–3520), federal agencies SUMMARY: The Food and Drug
Insurance Portability and
must obtain approval from the Office of Administration (FDA) is announcing
Accountability Act (HIPAA) became law
Management and Budget (OMB) for each that a proposed collection of
in 1996 (Pub. L. 104–191). Subtitle F of
collection of information they conduct information has been submitted to the
Title II of HIPAA, titled ‘‘Administrative
or sponsor. The term ‘‘collection of Office of Management and Budget
Simplification,’’ (A.S.) requires the
information’’ is defined in 44 U.S.C. (OMB) for review and clearance under
Secretary of HHS to adopt national
3502(3) and 5 CFR 1320.3(c) and the Paperwork Reduction Act of 1995.
standards for certain information-related
includes agency requests or activities of the health care industry. DATES: Fax written comments on the
requirements that members of the public The HIPAA provisions, by statute, apply collection of information by October 3,
submit reports, keep records, or provide only to ‘‘covered entities’’ referred to in 2016.
information to a third party. Section section 1320d–2(a)(1) of this title. ADDRESSES: To ensure that comments on
3506(c)(2)(A) of the PRA (44 U.S.C. Responsibility for administering and the information collection are received,
3506(c)(2)(A)) requires federal agencies enforcing the HIPAA A.S. Transactions, OMB recommends that written
mstockstill on DSK3G9T082PROD with NOTICES

to publish a 30-day notice in the Code Sets, Identifiers has been comments be faxed to the Office of
Federal Register concerning each delegated to the Centers for Medicare & Information and Regulatory Affairs,
proposed collection of information, Medicaid Services (CMS). This updated OMB, Attn: FDA Desk Officer, FAX:
including each proposed extension or information collection will be used to 202–395–7285, or emailed to oira_
reinstatement of an existing collection initiate enforcement actions. submission@omb.eop.gov. All
of information, before submitting the This reinstatement request clarifies comments should be identified with the
collection to OMB for approval. To the removal of the HIPAA Security OMB control number 0910–0669. Also

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Document Created: 2018-02-09 11:55:59
Document Modified: 2018-02-09 11:55:59

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.
Dates		Fax written comments on the collection of information by October 3, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		81 FR 60705

81 FR 60705 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 171 (September 2, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration