
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7815-7816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1010]


Completeness Assessments for Type II Active Pharmaceutical 
Ingredient Drug Master Files Under the Generic Drug User Fee Amendments 
of 2012; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Completeness 
Assessments for Type II API DMFs Under GDUFA''. It finalizes the draft 
guidance entitled ``Initial Completeness Assessments for Type II API 
DMFs Under GDUFA'', which published on October 2, 2012. This guidance 
is intended for holders of Type II active pharmaceutical ingredient 
(API) drug master files (DMFs) that are or will be referenced in an 
abbreviated new drug application (ANDA), an amendment to an ANDA, a 
prior approval supplement (PAS) to an ANDA, or an amendment to a PAS 
(generic drug submissions).

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-2012-D-1010 for ``Completeness Assessments for Type II API DMFs 
Under GDUFA''. 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 this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 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: Elizabeth Giaquinto Friedman, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New

[[Page 7816]]

Hampshire Ave., Bldg. 75, Rm. 1669, Silver Spring, MD 20993-0002, 240-
402-7930; or Huyi Zhang, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave, Bldg. 75, Rm. 6604, 
Silver Spring, MD 20993-0002, 240-402-8843; or Stephen Ripley, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Completeness Assessments for Type II API DMFs Under GDUFA''. 
This guidance is intended for holders of Type II API DMFs that are or 
will be referenced in an ANDA, an amendment to an ANDA, a PAS to an 
ANDA, or an amendment to a PAS (generic drug submissions). The guidance 
makes recommendations about the information that should be included in 
the DMF to facilitate a Generic Drug User Fee Amendments of 2012 
(GDUFA) Completeness Assessment (CA). The guidance does not apply to 
Type II API DMFs used to support new drug applications (NDAs), 
biologics license applications, other submissions that are not generic 
drug submissions, or any other types of DMFs.
    Under GDUFA, beginning October 1, 2012, the holder of a Type II API 
DMF must pay a one-time DMF fee when the DMF is first referenced in a 
generic drug submission submitted to FDA on the basis of a letter of 
authorization from the DMF holder. Also under GDUFA, holders of Type II 
API DMFs that were evaluated before October 1, 2012, must pay a one-
time fee for the DMF when their DMF is first referenced in a new ANDA, 
an ANDA amendment, or an ANDA PAS on or after October 1, 2012. Only 
Type II API DMFs for use in generic drug submissions incur this one-
time fee. Type II API DMFs intended for reference in a generic drug 
submission for which the fee is paid will undergo a CA. Although the 
requirement for a CA for Type II API DMFs is new, FDA has previously 
evaluated DMFs in accordance with the criteria set out in the GDUFA 
Completeness Assessment Checklist for Type II API DMFs (CA Checklist), 
attached to the guidance.
    This 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 ``Completeness Assessments for Type II API 
DMFs Under GDUFA''. 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.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02969 Filed 2-12-16; 8:45 am]
BILLING CODE 4164-01-P


