Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012; Guidance for Industry; Availability, 7815-7816 [2016-02969]

Download as PDF Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction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 parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910–0001, respectively. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–02964 Filed 2–12–16; 8:45 am] BILLING CODE 4164–01–P 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. 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 It finalizes the draft guidance entitled ‘‘Initial Completeness Assessments for Type II API DMFs Under GDUFA’’, which published on October 2, 2012.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). mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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 https://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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 7815 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 https://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: https://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 https:// 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 E:\FR\FM\16FEN1.SGM 16FEN1 7816 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES 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 onetime 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 VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 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 https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, or https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2000–D–0277] Allergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Allergic Rhinitis: Developing Drug Products for Treatment.’’ The purpose of this draft guidance is to assist sponsors in the development of drug products for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This draft guidance revises the draft guidance for industry entitled ‘‘Allergic Rhinitis: Clinical Development Programs for Drug Products’’ issued April 2000. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 18, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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– 2000–D–0277 for ‘‘Allergic Rhinitis: Developing Drug Products for Treatment.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 E:\FR\FM\16FEN1.SGM 16FEN1

Agencies

[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]


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

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.

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

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://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
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