82 FR 46072 - Abbreviated New Drug Applications Submissions-Refuse-To-Receive Standards: Questions and Answers; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46072-46073 | |
| FR Document | 2017-21187 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46072-46073] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21187] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5846] Abbreviated New Drug Applications Submissions--Refuse-To-Receive Standards: Questions and Answers; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ANDA Submissions--Refuse-to-Receive Standards: Questions and Answers.'' This draft guidance is intended to assist applicants preparing to submit abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs. This guidance provides answers to questions we have received from applicants regarding the guidance for industry, ``ANDA Submissions--Refuse-to-Receive Standards'' (RTR Standards guidance). The questions and answers address general issues about the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to Drug Master Files (DMFs), product quality, and bioequivalence (BE) and clinical reviews, and are intended to clarify the deficiencies that may cause FDA to refuse to receive (RTR) an ANDA. DATES: Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the [[Page 46073]] Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-5846 for ``ANDA Submissions--Refuse-to-Receive Standards: Questions and Answers.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``ANDA Submissions--Refuse-to-Receive Standards: Questions and Answers.'' This draft guidance is intended to assist applicants preparing to submit ANDAs and certain prior approval supplements (PASs) to ANDAs. This guidance provides answers to questions we have received from applicants regarding the guidance for industry, ``ANDA Submissions--Refuse-to-Receive Standards'' and the filing process, in general. The questions and answers address general issues about the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to DMFs, product quality, and BE and clinical reviews, and are intended to clarify the deficiencies that may cause FDA to RTR an ANDA. FDA evaluates each submitted ANDA individually to determine whether the Agency can receive it for review. When FDA decides to receive an ANDA, it means the Agency has made a threshold determination that the ANDA is a substantially complete application (i.e., an ANDA that, on its face, is sufficiently complete to permit a substantive review). FDA's regulations at 21 CFR 314.101 provide the regulatory authority by which FDA may in certain cases, and will in others, RTR an ANDA. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``ANDA Submissions--Refuse-to-Receive Standards.'' 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. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: September 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21187 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
![46072 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
contact information to be made publicly This draft guidance reflects a unified These collections of information are
available, you can provide this approach to all formal meetings between subject to review by the Office of
information on the cover sheet and not FDA and ANDA applicants or Management and Budget (OMB) under
in the body of your comments and you prospective ANDA applicants for the Paperwork Reduction Act of 1995
must identify this information as complex products. This draft guidance (44 U.S.C. 3501–3520). The collection of
‘‘confidential.’’ Any information marked is intended to assist ANDA applicants information has been approved under
as ‘‘confidential’’ will not be disclosed and prospective ANDA applicants in OMB control number 0910–0797.
except in accordance with 21 CFR 10.20 generating and submitting to FDA a
III. Electronic Access
and other applicable disclosure law. For meeting request and the associated
more information about FDA’s posting meeting package for these complex Persons with access to the internet
of comments to public dockets, see 80 products, as defined in this guidance, to may obtain the draft guidance at either
FR 56469, September 18, 2015, or access be submitted under section 505(j) of the https://www.fda.gov/Drugs/Guidance
the information at: https://www.gpo.gov/ FD&C Act (21 U.S.C 355(j)) and as ComplianceRegulatoryInformation/
fdsys/pkg/FR-2015-09-18/pdf/2015- contemplated in GDUFA II. Guidances/default.htm or https://www.
23389.pdf. As part of the commitments FDA regulations.gov.
Docket: For access to the docket to made in connection with GDUFA II, Dated: September 28, 2017.
read background documents or the FDA agreed to develop a program to Anna K. Abram,
electronic and written/paper comments assist ANDA applicants and prospective
Deputy Commissioner for Policy, Planning,
received, go to https:// ANDA applicants of complex products Legislation, and Analysis.
www.regulations.gov and insert the before the submission of an ANDA to
[FR Doc. 2017–21190 Filed 10–2–17; 8:45 am]
docket number, found in brackets in the FDA. As stated in the ‘‘GDUFA
BILLING CODE 4164–01–P
heading of this document, into the Reauthorization Performance Goals and
‘‘Search’’ box and follow the prompts Program Enhancements Fiscal Years
and/or go to the Dockets Management 2018–2022’’ (GDUFA II Goals or DEPARTMENT OF HEALTH AND
Staff, 5630 Fishers Lane, Rm. 1061, Commitment Letter), this pre-ANDA HUMAN SERVICES
Rockville, MD 20852. program is intended to:
You may submit comments on any . . . clarify regulatory expectations for Food and Drug Administration
guidance at any time (see 21 CFR prospective applicants early in product
development, assist applicants to develop [Docket No. FDA–2017–D–5846]
10.115(g)(5)).
more complete submissions, promote a more
Submit written requests for single efficient and effective ANDA review process, Abbreviated New Drug Applications
copies of the draft guidance to the and reduce the number of review cycles Submissions—Refuse-To-Receive
Division of Drug Information, Center for required to obtain ANDA approval, Standards: Questions and Answers;
Drug Evaluation and Research, Food particularly for [complex products](GDUFA Draft Guidance for Industry;
and Drug Administration, 10001 New II Commitment Letter at 14). Availability
Hampshire Ave., Hillandale Building, To facilitate development of complex
4th Floor, Silver Spring, MD 20993– AGENCY: Food and Drug Administration,
products that may be submitted in an
0002. Send one self-addressed adhesive HHS.
ANDA, FDA and industry agreed to a
label to assist that office in processing series of meetings between ANDA ACTION: Notice of availability.
your requests. See the SUPPLEMENTARY applicants and prospective ANDA
INFORMATION section for electronic SUMMARY: The Food and Drug
applicants and FDA to discuss the Administration (FDA or Agency) is
access to the draft guidance document. proposed complex product and support announcing the availability of a draft
FOR FURTHER INFORMATION CONTACT: submission of a high-quality, guidance for industry entitled ‘‘ANDA
Elizabeth Giaquinto Friedman, Center approvable ANDA. Submissions—Refuse-to-Receive
for Drug Evaluation and Research, Food In addition to developing a robust
Standards: Questions and Answers.’’
and Drug Administration, 10903 New pre-ANDA program, FDA agreed to
This draft guidance is intended to assist
Hampshire Ave., Bldg. 75, Rm. 1670, respond to requests for and conduct
applicants preparing to submit
Silver Spring, MD 20993–0002, 240– meetings related to the development of
abbreviated new drug applications
402–7930, elizabeth.giaquinto@ complex products submitted on or after
(ANDAs) and certain prior approval
fda.hhs.gov. October 1, 2017, within specific
supplements (PASs) to ANDAs. This
timeframes.
SUPPLEMENTARY INFORMATION: This draft guidance is being issued guidance provides answers to questions
consistent with FDA’s good guidance we have received from applicants
I. Background regarding the guidance for industry,
practices regulation (21 CFR 10.115).
FDA is announcing the availability of The draft guidance, when finalized, will ‘‘ANDA Submissions—Refuse-to-
a draft guidance for industry entitled represent the current thinking of FDA Receive Standards’’ (RTR Standards
‘‘Formal Meetings Between FDA and on ‘‘Formal Meetings Between FDA and guidance). The questions and answers
ANDA Applicants of Complex Products ANDA Applicants of Complex Products address general issues about the
Under GDUFA.’’ This draft guidance Under GDUFA.’’ It does not establish organization of an ANDA, filing
describes an enhanced pathway for any rights for any person and is not decisions made by FDA, the review of
and deficiencies related to Drug Master
asabaliauskas on DSKBBXCHB2PROD with NOTICES
discussions between FDA and an binding on FDA or the public. You can
applicant (or prospective applicant) use an alternative approach if it satisfies Files (DMFs), product quality, and
preparing to submit an ANDA for a the requirements of the applicable bioequivalence (BE) and clinical
complex product to FDA. Specifically, statutes and regulations. reviews, and are intended to clarify the
this draft guidance provides information deficiencies that may cause FDA to
on requesting and conducting product II. Paperwork Reduction Act of 1995 refuse to receive (RTR) an ANDA.
development meetings, pre-submission This draft guidance refers to DATES: Submit either electronic or
meetings, and mid-review-cycle previously approved collections of written comments on the draft guidance
meetings with FDA. information found in FDA regulations. by December 4, 2017 to ensure that the
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![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46073
Agency considers your comment on this made publicly available, submit your I. Background
draft guidance before it begins work on comments only as a written/paper
the final version of the guidance. submission. You should submit two FDA is announcing the availability of
ADDRESSES: You may submit comments copies total. One copy will include the a draft guidance for industry entitled
on any guidance at any time as follows: information you claim to be confidential ‘‘ANDA Submissions—Refuse-to-
with a heading or cover note that states Receive Standards: Questions and
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS Answers.’’ This draft guidance is
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The intended to assist applicants preparing
following way: Agency will review this copy, including to submit ANDAs and certain prior
• Federal eRulemaking Portal: the claimed confidential information, in approval supplements (PASs) to
https://www.regulations.gov. Follow the its consideration of comments. The ANDAs. This guidance provides
instructions for submitting comments. second copy, which will have the answers to questions we have received
Comments submitted electronically, claimed confidential information from applicants regarding the guidance
including attachments, to https:// redacted/blacked out, will be available for industry, ‘‘ANDA Submissions—
www.regulations.gov will be posted to for public viewing and posted on Refuse-to-Receive Standards’’ and the
the docket unchanged. Because your https://www.regulations.gov. Submit filing process, in general. The questions
comment will be made public, you are both copies to the Dockets Management and answers address general issues
solely responsible for ensuring that your Staff. If you do not wish your name and about the organization of an ANDA,
comment does not include any contact information to be made publicly
confidential information that you or a filing decisions made by FDA, the
available, you can provide this review of and deficiencies related to
third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or DMFs, product quality, and BE and
in the body of your comments and you
anyone else’s Social Security number, or clinical reviews, and are intended to
must identify this information as
confidential business information, such clarify the deficiencies that may cause
‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed FDA to RTR an ANDA. FDA evaluates
that if you include your name, contact except in accordance with 21 CFR 10.20 each submitted ANDA individually to
information, or other information that and other applicable disclosure law. For determine whether the Agency can
identifies you in the body of your more information about FDA’s posting receive it for review. When FDA decides
comments, that information will be of comments to public dockets, see 80 to receive an ANDA, it means the
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access Agency has made a threshold
• If you want to submit a comment the information at: https://www.fda.gov determination that the ANDA is a
with confidential information that you /regulatoryinformation/dockets/ substantially complete application (i.e.,
do not wish to be made available to the default.htm. an ANDA that, on its face, is sufficiently
public, submit the comment as a Docket: For access to the docket to complete to permit a substantive
written/paper submission and in the read background documents or the review). FDA’s regulations at 21 CFR
manner detailed (see ‘‘Written/Paper electronic and written/paper comments 314.101 provide the regulatory authority
Submissions’’ and ‘‘Instructions’’). received, go to https:// by which FDA may in certain cases, and
Written/Paper Submissions www.regulations.gov and insert the will in others, RTR an ANDA.
docket number, found in brackets in the
Submit written/paper submissions as This draft guidance is being issued
heading of this document, into the
follows: consistent with FDA’s good guidance
‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for practices regulation (21 CFR 10.115).
and/or go to the Dockets Management
written/paper submissions): Dockets The draft guidance, when finalized, will
Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and represent the current thinking of FDA
Rockville, MD 20852.
Drug Administration, 5630 Fishers You may submit comments on any on ‘‘ANDA Submissions—Refuse-to-
Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR Receive Standards.’’ It does not
• For written/paper comments establish any rights for any person and
10.115(g)(5)).
submitted to the Dockets Management Submit written requests for single is not binding on FDA or the public.
Staff, FDA will post your comment, as copies of the draft guidance to the You can use an alternative approach if
well as any attachments, except for Division of Drug Information, Center for it satisfies the requirements of the
information submitted, marked and Drug Evaluation and Research, Food applicable statutes and regulations. This
identified, as confidential, if submitted and Drug Administration, 10001 New guidance is not subject to Executive
as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, Order 12866.
Instructions: All submissions received
4th Floor, Silver Spring, MD 20993–
must include the Docket No. FDA– II. Electronic Access
0002. Send one self-addressed adhesive
2017–D–5846 for ‘‘ANDA
label to assist that office in processing Persons with access to the internet
Submissions—Refuse-to-Receive
your requests. See the SUPPLEMENTARY may obtain the draft guidance at either
Standards: Questions and Answers.’’
INFORMATION section for electronic
Received comments will be placed in https://www.fda.gov/Drugs/Guidance
access to the draft guidance document. ComplianceRegulatoryInformation/
the docket and, except for those
FOR FURTHER INFORMATION CONTACT:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
submitted as ‘‘Confidential Guidances/default.htm or https://
Submissions,’’ publicly viewable at Elizabeth Giaquinto Friedman, Center www.regulations.gov.
https://www.regulations.gov or at the for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Dated: September 28, 2017.
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 75, Rm. 1670, Anna K. Abram,
Friday. Silver Spring, MD 20993–0002, 240– Deputy Commissioner for Policy, Planning,
• Confidential Submissions—To 402–7930, elizabeth.giaquinto@ Legislation, and Analysis.
submit a comment with confidential fda.hhs.gov. [FR Doc. 2017–21187 Filed 10–2–17; 8:45 am]
information that you do not wish to be SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P
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Document Created: 2017-10-03 01:01:47
Document Modified: 2017-10-03 01:01:47
| 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 the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930, [email protected] | |
| FR Citation | 82 FR 46072 |
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