81 FR 3429 - Target Animal Safety Data Presentation and Statistical Analysis; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 13 (January 21, 2016)

Page Range		3429-3430
FR Document		2016-01098

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #226 entitled ``Target Animal Safety Data Presentation and Statistical Analysis.'' The purpose of this document is to provide recommendations to industry regarding the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine (CVM) as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry).

Federal Register, Volume 81 Issue 13 (Thursday, January 21, 2016)

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3429-3430]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0839]


Target Animal Safety Data Presentation and Statistical Analysis; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry (GFI) #226 entitled 
``Target Animal Safety Data Presentation and Statistical Analysis.'' 
The purpose of this document is to provide recommendations to industry 
regarding the presentation and statistical analyses of target animal 
safety (TAS) data submitted to the Center for Veterinary Medicine (CVM) 
as part of a study report to support approval of a new animal drug. 
These recommendations apply to TAS data generated from both TAS and 
field effectiveness studies conducted in companion animals (e.g., dogs, 
cats, and horses) and food animals (e.g., swine, ruminants, fish, and 
poultry).

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-0839 for Target Animal Safety Data Presentation and 
Statistical Analysis. Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Virginia Recta, Center for Veterinary 
Medicine (HFV-160), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0840, [email protected],

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 31, 2015 (80 FR 17047), FDA 
published the notice of availability for a draft guidance entitled 
``Target Animal Safety Data Presentation and Statistical Analysis'' 
giving interested persons until June 1, 2015, to comment on the draft 
guidance. FDA received two comments on the draft guidance and those 
comments were considered as the guidance was finalized. Some of the 
suggested changes were incorporated, and additional editorial changes 
were made to improve clarity. The guidance announced in this notice 
finalizes the draft guidance dated March 2015.
    This GFI provides recommendations to industry regarding the 
presentation

[[Page 3430]]

and statistical analyses of target animal safety (TAS) data submitted 
to CVM as part of a study report to support approval of a new animal 
drug. These recommendations apply to TAS data generated from both TAS 
and field effectiveness studies conducted in companion animals (e.g., 
dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, 
and poultry).

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on Target Animal Safety Data Presentation 
and Statistical Analysis. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 514 have been approved under 
OMB control number 0910-0032.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: January 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01098 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P

3430 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices

and statistical analyses of target animal DEPARTMENT OF HEALTH AND the same strength and dosage form as
safety (TAS) data submitted to CVM as HUMAN SERVICES the ‘‘listed drug,’’ which is a version of
part of a study report to support the drug that was previously approved.
approval of a new animal drug. These Food and Drug Administration ANDA applicants do not have to repeat
recommendations apply to TAS data [Docket No. FDA–2016–N–0119] the extensive clinical testing otherwise
generated from both TAS and field necessary to gain approval of a new
effectiveness studies conducted in Determination That THORAZINE drug application (NDA).
companion animals (e.g., dogs, cats, and (Chlorpromazine Hydrochloride)
horses) and food animals (e.g., swine, The 1984 amendments include what
Tablets and Other Drug Products Were
ruminants, fish, and poultry). is now section 505(j)(7) of the Federal
Not Withdrawn From Sale for Reasons
Food, Drug, and Cosmetic Act (21 U.S.C.
II. Significance of Guidance of Safety or Effectiveness
355(j)(7)), which requires FDA to
This level 1 guidance is being issued AGENCY: Food and Drug Administration, publish a list of all approved drugs.
consistent with FDA’s good guidance HHS. FDA publishes this list as part of the
practices regulation (21 CFR 10.115). ACTION: Notice. ‘‘Approved Drug Products With
The guidance represents the current Therapeutic Equivalence Evaluations,’’
thinking of FDA on Target Animal SUMMARY: The Food and Drug
which is generally known as the
Safety Data Presentation and Statistical Administration (FDA or Agency) has
‘‘Orange Book’’. Under FDA regulations,
Analysis. It does not establish any rights determined that the drug products listed
in this document were not withdrawn a drug is removed from the list if the
for any person and is not binding on Agency withdraws or suspends
FDA or the public. You can use an from sale for reasons of safety or
effectiveness. This determination means approval of the drug’s NDA or ANDA
alternative approach if it satisfies the
that FDA will not begin procedures to for reasons of safety or effectiveness, or
requirements of the applicable statutes
withdraw approval of abbreviated new if FDA determines that the listed drug
and regulations.
drug applications (ANDAs) that refer to was withdrawn from sale for reasons of
III. Paperwork Reduction Act of 1995 these drug products, and it will allow safety or effectiveness (21 CFR 314.162).
This guidance refers to previously FDA to continue to approve ANDAs that Under § 314.161(a) (21 CFR
approved collections of information refer to the products as long as they 314.161(a)), the Agency must determine
found in FDA regulations. These meet relevant legal and regulatory whether a listed drug was withdrawn
collections of information are subject to requirements. from sale for reasons of safety or
review by the Office of Management and FOR FURTHER INFORMATION CONTACT: effectiveness: (1) Before an ANDA that
Budget (OMB) under the Paperwork Stacy Kane, Center for Drug Evaluation refers to that listed drug may be
Reduction Act of 1995 (44 U.S.C. 3501– and Research, Food and Drug approved, (2) whenever a listed drug is
3520). The collections of information in Administration, 10903 New Hampshire voluntarily withdrawn from sale and
21 CFR part 514 have been approved Ave., Bldg. 51, Rm. 6207, Silver Spring, ANDAs that refer to the listed drug have
under OMB control number 0910–0032. MD 20993–0002, 301–796–8363, been approved, and (3) when a person
IV. Electronic Access Stacy.Kane@fda.hhs.gov. petitions for such a determination under
SUPPLEMENTARY INFORMATION: In 1984, 21 CFR 10.25(a) and 10.30. Section
Persons with access to the Internet
may obtain the draft guidance at either Congress enacted the Drug Price 314.161(d) provides that if FDA
http://www.fda.gov/AnimalVeterinary/ Competition and Patent Term determines that a listed drug was
GuidanceComplianceEnforcement/ Restoration Act of 1984 (Pub. L. 98–417) withdrawn from sale for safety or
GuidanceforIndustry/default.htm or (the 1984 amendments), which effectiveness reasons, the Agency will
http://www.regulations.gov. authorized the approval of duplicate initiate proceedings that could result in
versions of drug products approved the withdrawal of approval of the
Dated: January 13, 2016. under an ANDA procedure. ANDA
Leslie Kux, ANDAs that refer to the listed drug.
applicants must, with certain
Associate Commissioner for Policy. exceptions, show that the drug for FDA has become aware that the drug
[FR Doc. 2016–01098 Filed 1–20–16; 8:45 am] which they are seeking approval products listed in the table in this
BILLING CODE 4164–01–P contains the same active ingredient in document are no longer being marketed.

Application No. Drug Applicant

NDA 009149 ...... THORAZINE (chlorpromazine hydrochloride (HCl)) Tablet; Oral, 10 milligrams (mg); 25 mg; GlaxoSmithKline.
50 mg; 100 mg; 200 mg.
NDA 016793 ...... CYTARABINE (cytarabine) Injectable; Injection, 100 mg/vial; 500 mg/vial; 1 gram (g)/vial; 2 Teva Pharmaceuticals USA,
g/vial. Inc.
NDA 018343 ...... CAPOTEN (captopril) Tablet; Oral, 37.5 mg; 75 mg; 150 mg .................................................. Par Pharmaceutical, Inc.
NDA 020845 ...... INOMAX (nitric oxide) Gas; Inhalation, 100 parts per million ................................................... Ino Therapeutics, Inc.
NDA 021178 ...... GLUCOVANCE (glyburide; metformin HCl) Tablet; Oral, 1.25 mg; 250 mg ............................ Bristol-Myers Squibb
NDA 050443 ...... BLENOXANE (bleomycin sulfate) Injectable; Injection, EQ 15 units base/vial; EQ 30 units Bristol-Myers Squibb
base/vial.
asabaliauskas on DSK9F6TC42PROD with NOTICES

NDA 050526 ...... STATICIN (erythromycin) Solution; Topical, 1.5% .................................................................... Westwood-Squibb Pharma-
ceuticals, Inc.
NDA 050675 ...... VANTIN (cefpodoxime proxetil) For Suspension; Oral, EQ 50 mg base/5 mL; EQ 100 mg Pharmacia & Upjohn Co.
base/5 mL.
NDA 203595 ...... SUCLEAR (magnesium sulfate, polyethylene glycol 3350, potassium chloride, potassium Braintree Laboratories, Inc.
sulfate, sodium bicarbonate, sodium chloride, sodium sulfate) Solution; Oral, 1.6 g, 210 g,
0.74 g, 3.13 g, 2.86 g, 5.6 g, 17.5 g.
ANDA 061827 .... CLEOCIN (clindamycin palmitate HCl) For Solution; Oral, EQ 75 mg base/5 mL ................... Pharmacia & Upjohn Co.

VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1

Document Created: 2018-02-02 12:33:41
Document Modified: 2018-02-02 12:33:41

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 of availability.
Dates		Submit either electronic or written comments on Agency guidances at any time.
Contact		Virginia Recta, Center for Veterinary Medicine (HFV-160), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0840, [email protected],
FR Citation		81 FR 3429

81 FR 3429 - Target Animal Safety Data Presentation and Statistical Analysis; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 13 (January 21, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration