81 FR 7815 - Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 30 (February 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 30 (February 16, 2016)
| Page Range | 7815-7816 | |
| FR Document | 2016-02969 |
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)] [Notices] [Pages 7815-7816] From the Federal Register Online [www.thefederalregister.org] [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 It finalizes the draft guidance entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA'', which published on October 2, 2012.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: 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
![Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7815
on FDA or the public. You can use an DATES: Submit either electronic or made publicly available, submit your
alternative approach if it satisfies the written comments on Agency guidances comments only as a written/paper
requirements of the applicable statutes at any time. submission. You should submit two
and regulations. ADDRESSES: You may submit comments copies total. One copy will include the
as follows: information you claim to be confidential
II. The Paperwork Reduction Act of
with a heading or cover note that states
1995 Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
This draft guidance refers to Submit electronic comments in the CONFIDENTIAL INFORMATION’’. The
previously approved collections of following way: Agency will review this copy, including
information that are subject to review by • Federal eRulemaking Portal: http:// the claimed confidential information, in
the Office of Management and Budget www.regulations.gov. Follow the its consideration of comments. The
(OMB) under the Paperwork Reduction instructions for submitting comments. second copy, which will have the
Act of 1995 (44 U.S.C. 3501–3520). The Comments submitted electronically, claimed confidential information
collections of information in 21 CFR including attachments, to http:// redacted/blacked out, will be available
parts 312 and 314 have been approved www.regulations.gov will be posted to for public viewing and posted on
under OMB control numbers 0910–0014 the docket unchanged. Because your http://www.regulations.gov. Submit
and 0910–0001, respectively. comment will be made public, you are both copies to the Division of Dockets
solely responsible for ensuring that your Management. If you do not wish your
III. Electronic Access comment does not include any name and contact information to be
Persons with access to the Internet confidential information that you or a made publicly available, you can
may obtain the draft guidance at either third party may not wish to be posted, provide this information on the cover
http://www.fda.gov/Drugs/Guidance such as medical information, your or sheet and not in the body of your
ComplianceRegulatoryInformation/ anyone else’s Social Security number, or comments and you must identify this
Guidances/default.htm or http:// confidential business information, such information as ‘‘confidential.’’ Any
www.regulations.gov. as a manufacturing process. Please note information marked as ‘‘confidential’’
that if you include your name, contact will not be disclosed except in
Dated: February 9, 2016.
information, or other information that accordance with 21 CFR 10.20 and other
Leslie Kux, identifies you in the body of your applicable disclosure law. For more
Associate Commissioner for Policy. comments, that information will be information about FDA’s posting of
[FR Doc. 2016–02964 Filed 2–12–16; 8:45 am] posted on http://www.regulations.gov. comments to public dockets, see 80 FR
BILLING CODE 4164–01–P • If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the regulatoryinformation/dockets/
DEPARTMENT OF HEALTH AND public, submit the comment as a default.htm.
HUMAN SERVICES written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Written/Paper Submissions received, go to http://
[Docket No. FDA–2012–D–1010]
www.regulations.gov and insert the
Submit written/paper submissions as
Completeness Assessments for Type II docket number, found in brackets in the
follows:
Active Pharmaceutical Ingredient Drug • Mail/Hand delivery/Courier (for heading of this document, into the
Master Files Under the Generic Drug written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
User Fee Amendments of 2012; Dockets Management (HFA–305), Food and/or go to the Division of Dockets
Guidance for Industry; Availability and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, • For written/paper comments Submit written requests for single
HHS. submitted to the Division of Dockets copies of this guidance to the Division
ACTION: Notice of availability. Management, FDA will post your of Drug Information, Center for Drug
comment, as well as any attachments, Evaluation and Research, Food and
SUMMARY: The Food and Drug except for information submitted, Drug Administration, 10001 New
Administration (FDA or Agency) is marked and identified, as confidential, Hampshire Ave., Hillandale Building,
announcing the availability of a if submitted as detailed in 4th Floor, Silver Spring, MD 20993–
guidance for industry entitled ‘‘Instructions.’’ 0002; or to the Office of
‘‘Completeness Assessments for Type II Instructions: All submissions received Communication, Outreach and
API DMFs Under GDUFA’’. It finalizes must include the Docket No. FDA– Development, Center for Biologics
the draft guidance entitled ‘‘Initial 2012–D–1010 for ‘‘Completeness Evaluation and Research, Food and
Completeness Assessments for Type II Assessments for Type II API DMFs Drug Administration, 10903 New
API DMFs Under GDUFA’’, which Under GDUFA’’. Received comments Hampshire Ave., Bldg. 71, Rm. 3128,
published on October 2, 2012. This will be placed in the docket and, except Silver Spring, MD 20993–0002. Send
guidance is intended for holders of Type for those submitted as ‘‘Confidential one self-addressed adhesive label to
assist that office in processing your
mstockstill on DSK4VPTVN1PROD with NOTICES
II active pharmaceutical ingredient Submissions,’’ publicly viewable at
(API) drug master files (DMFs) that are http://www.regulations.gov or at the requests. See the SUPPLEMENTARY
or will be referenced in an abbreviated Division of Dockets Management INFORMATION section for electronic
new drug application (ANDA), an between 9 a.m. and 4 p.m., Monday access to the guidance document.
amendment to an ANDA, a prior through Friday. FOR FURTHER INFORMATION CONTACT:
approval supplement (PAS) to an • Confidential Submissions—To Elizabeth Giaquinto Friedman, Center
ANDA, or an amendment to a PAS submit a comment with confidential for Drug Evaluation and Research, Food
(generic drug submissions). information that you do not wish to be and Drug Administration, 10903 New
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![7816 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
Hampshire Ave., Bldg. 75, Rm. 1669, any rights for any person and is not • Federal eRulemaking Portal: http://
Silver Spring, MD 20993–0002, 240– binding on FDA or the public. You can www.regulations.gov. Follow the
402–7930; or Huyi Zhang, Center for use an alternative approach if it satisfies instructions for submitting comments.
Drug Evaluation and Research, Food the requirements of the applicable Comments submitted electronically,
and Drug Administration, 10903 New statutes and regulations. including attachments, to http://
Hampshire Ave, Bldg. 75, Rm. 6604, www.regulations.gov will be posted to
Silver Spring, MD 20993–0002, 240– II. Electronic Access the docket unchanged. Because your
402–8843; or Stephen Ripley, Center for Persons with access to the Internet comment will be made public, you are
Biologics Evaluation and Research, may obtain the guidance at either solely responsible for ensuring that your
Food and Drug Administration, 10903 http://www.fda.gov/Drugs/ comment does not include any
New Hampshire Ave., Bldg. 71, Rm. GuidanceCompliance confidential information that you or a
7301, Silver Spring, MD 20993–0002, RegulatoryInformation/Guidances/ third party may not wish to be posted,
240–402–7911. default.htm, http://www.fda.gov/ such as medical information, your or
SUPPLEMENTARY INFORMATION: BiologicsBloodVaccines/ anyone else’s Social Security number, or
GuidanceCompliance confidential business information, such
I. Background RegulatoryInformation/Guidances/ as a manufacturing process. Please note
FDA is announcing the availability of default.htm, or http:// that if you include your name, contact
a guidance for industry entitled www.regulations.gov. information, or other information that
‘‘Completeness Assessments for Type II Dated: February 9, 2016. identifies you in the body of your
API DMFs Under GDUFA’’. This comments, that information will be
Leslie Kux,
guidance is intended for holders of Type posted on http://www.regulations.gov.
II API DMFs that are or will be Associate Commissioner for Policy. • If you want to submit a comment
referenced in an ANDA, an amendment [FR Doc. 2016–02969 Filed 2–12–16; 8:45 am] with confidential information that you
to an ANDA, a PAS to an ANDA, or an BILLING CODE 4164–01–P do not wish to be made available to the
amendment to a PAS (generic drug public, submit the comment as a
submissions). The guidance makes written/paper submission and in the
recommendations about the information DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
that should be included in the DMF to HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
facilitate a Generic Drug User Fee
Food and Drug Administration Written/Paper Submissions
Amendments of 2012 (GDUFA)
Completeness Assessment (CA). The [Docket No. FDA–2000–D–0277] Submit written/paper submissions as
guidance does not apply to Type II API follows:
DMFs used to support new drug Allergic Rhinitis: Developing Drug • Mail/Hand delivery/Courier (for
applications (NDAs), biologics license Products for Treatment; Draft written/paper submissions): Division of
applications, other submissions that are Guidance for Industry; Availability Dockets Management (HFA–305), Food
not generic drug submissions, or any and Drug Administration, 5630 Fishers
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
other types of DMFs. HHS.
Under GDUFA, beginning October 1, • For written/paper comments
2012, the holder of a Type II API DMF ACTION: Notice of availability. submitted to the Division of Dockets
must pay a one-time DMF fee when the Management, FDA will post your
SUMMARY: The Food and Drug comment, as well as any attachments,
DMF is first referenced in a generic drug Administration (FDA or Agency) is
submission submitted to FDA on the except for information submitted,
announcing the availability of a draft marked and identified, as confidential,
basis of a letter of authorization from the
guidance for industry entitled ‘‘Allergic if submitted as detailed in
DMF holder. Also under GDUFA,
Rhinitis: Developing Drug Products for ‘‘Instructions.’’
holders of Type II API DMFs that were
Treatment.’’ The purpose of this draft Instructions: All submissions received
evaluated before October 1, 2012, must
guidance is to assist sponsors in the must include the Docket No. FDA–
pay a one-time fee for the DMF when
development of drug products for the 2000–D–0277 for ‘‘Allergic Rhinitis:
their DMF is first referenced in a new
treatment of seasonal allergic rhinitis Developing Drug Products for
ANDA, an ANDA amendment, or an
(SAR) and perennial allergic rhinitis Treatment.’’ Received comments will be
ANDA PAS on or after October 1, 2012.
(PAR). This draft guidance revises the placed in the docket and, except for
Only Type II API DMFs for use in
draft guidance for industry entitled those submitted as ‘‘Confidential
generic drug submissions incur this one-
time fee. Type II API DMFs intended for ‘‘Allergic Rhinitis: Clinical Submissions,’’ publicly viewable at
reference in a generic drug submission Development Programs for Drug http://www.regulations.gov or at the
for which the fee is paid will undergo Products’’ issued April 2000. Division of Dockets Management
a CA. Although the requirement for a DATES: Although you can comment on between 9 a.m. and 4 p.m., Monday
CA for Type II API DMFs is new, FDA any guidance at any time (see 21 CFR through Friday.
has previously evaluated DMFs in 10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To
accordance with the criteria set out in considers your comment on this draft submit a comment with confidential
the GDUFA Completeness Assessment guidance before it begins work on the information that you do not wish to be
Checklist for Type II API DMFs (CA final version of the guidance, submit made publicly available, submit your
either electronic or written comments
mstockstill on DSK4VPTVN1PROD with NOTICES
Checklist), attached to the guidance. comments only as a written/paper
This guidance is being issued on the draft guidance by April 18, 2016. submission. You should submit two
consistent with FDA’s good guidance ADDRESSES: You may submit comments copies total. One copy will include the
practices regulation (21 CFR 10.115). as follows: information you claim to be confidential
The guidance represents the current with a heading or cover note that states
thinking of FDA on ‘‘Completeness Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Assessments for Type II API DMFs Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Under GDUFA’’. It does not establish following way: Agency will review this copy, including
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Document Created: 2016-02-13 03:13:06
Document Modified: 2016-02-13 03:13:06
| 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 | Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New 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. | |
| FR Citation | 81 FR 7815 |
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