[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Notices]
[Pages 51421-51424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-3101]


Abbreviated New Drug Applications: Pre-Submission of Facility 
Information Related to Prioritized Generic Drug Applications (Pre-
Submission Facility Correspondence); Draft Guidance for Industry; 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the availability of a revised draft guidance for industry entitled 
``ANDAs: Pre-Submission of Facility Information Related to Prioritized 
Generic Drug Applications (Pre-Submission Facility Correspondence).'' 
FDA is revising the draft guidance because, after issuance of the 
original draft guidance, the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) was amended by the FDA Reauthorization Act of 2017, which 
resulted in changes to the pre-submission of facility information. Pre-
submitting facility information enables the Agency to determine whether 
inspection of a facility is necessary and, if so, to begin inspection 
planning in advance of an abbreviated new drug application (ANDA) 
receipt.

DATES: Submit either electronic or written comments on the draft 
guidance by February 5, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 
concerning the collection of information proposed in the draft guidance 
by January 5, 2018.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

[[Page 51422]]

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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-3101 for ``ANDAs: Pre-Submission of Facility Information 
Related to Prioritized Generic Drug Applications (Pre-Submission 
Facility Correspondence).'' 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.
    <bullet> 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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: Nikhil Thakur, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 4161, Silver Spring, MD 20993, 301-796-
5536.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``ANDAs: Pre-Submission of Facility Information 
Related to Prioritized Generic Drug Applications (Pre-Submission 
Facility Correspondence).'' The first draft of this document, entitled 
``ANDAs: Pre-Submission Facility Correspondence Associated with 
Priority Submissions,'' was issued pursuant to 21 CFR 10.115 in June 
2017. The docket number has not changed since the first draft of this 
document was issued, and it is not necessary to resubmit comments 
already submitted to the docket. The Agency will consider comments 
submitted with respect to the first draft of this document in 
finalizing the revised document.
    The Agency is issuing this revised draft guidance to describe the 
process through which prospective generic drug applicants submit 
facility information in advance of an original ANDA, prior approval 
supplement (PAS), PAS amendment, or ANDA amendment (hereafter 
collectively referred to as ANDA). FDA is revising the draft guidance 
because, after issuance of the original draft guidance, section 
505(j)(11) of the FD&C Act (21 U.S.C. 355(j)(11)) as added by section 
801 of the FDA Reauthorization Act of 2017 (FDARA) resulted in changes 
to the pre-submission of facility information.
    In 2016 and 2017, FDA, regulated industry, and public stakeholders 
conducted negotiations concerning reauthorization of the Generic Drug 
User Fee Amendments (GDUFA II). A chief product of these 
congressionally mandated discussions was the ``GDUFA Reauthorization 
Performance Goals and Program Enhancements, FYs 2018-2022'' (GDUFA II 
Commitment Letter) available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf. Together, the 
Generic Drug User Fee Amendments of 2017 and the GDUFA II Commitment 
Letter describe FDA's performance goals, as well as changes and 
improvements to the user fee program.
    On August 18, 2017, FDARA, which reauthorized the Generic Drug User 
Fee Amendments (Title III) as well as other provisions related to 
generic drugs (Title VIII), was signed into law. In particular, section 
801 of the FDARA added section 505(j)(11) to the FD&C Act to address 
priority review of generic drugs. One of the enhancements specified in 
both Title VIII, section 801 of FDARA, and the GDUFA II Commitment 
Letter is a mechanism to enable a shorter review goal (priority review 
goal) for certain priority original ANDAs, PASs, PAS amendments, and 
ANDA amendments through the pre-submission of facility information, 
including sections of the ANDA determined to be relevant by FDA. 
Specifically, this guidance describes:
    <bullet> The content and format of the facility information that 
should be submitted to enable FDA's assessment of facilities listed in 
the pre-submission.

[[Page 51423]]

    <bullet> Timeframes for pre-submitting sections of the ANDA 
containing complete, accurate information, and the intersection of 
these timeframes with submission of the ANDA.
    <bullet> The possible outcomes of the Agency's assessment of pre-
submitted ANDA sections containing facility information.
    <bullet> When and how the Agency notifies an applicant about the 
status of the pre-submitted ANDA sections containing facility 
information.
    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 ANDAs: Pre-
Submission of Facility Information Related to Prioritized Generic Drug 
Applications (Pre-Submission Facility Correspondence). 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. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing the 
proposed collection of information set forth in this notice of 
availability that would result from the pre-submission of facility 
information.
    With respect to the following collection of information, FDA 
invites comment on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Draft Guidance for Industry on ANDAs: Pre-Submission of 
Facility Information Related to Prioritized Generic Drug Applications 
(Pre-Submission Facility Correspondence).
    Description: As described in the draft guidance, section 505(j)(11) 
of the FD&C Act was added by section 801 of FDARA. Pre-submitting 
facility information enables the Agency to determine whether inspection 
of a facility is necessary and, if so, to begin inspection planning in 
advance of ANDA receipt.
    This draft guidance document refers to previously approved 
collections of information found in FDA regulations. These collections 
of information are subject to review by OMB under the PRA. Existing 
regulations at 21 CFR 314.94 provide the content and format of an ANDA, 
and consistent with GDUFA II, this draft guidance describes the 
relevant sections of an ANDA that should be submitted as part of the 
pre-submission of facility information. The information collections 
associated with the submission of these ANDA sections are approved 
under OMB control number 0910-0001.
    There are information collections proposed in the draft guidance 
that are not already addressed under the approved control numbers 
covering ANDA submissions. Section IV of the draft guidance describes 
the information that should be included in the pre-submission of 
facility information to enable FDA's facility assessment:
    A. The planned ANDA pre-assigned number to be submitted with the 
pre-submission, which the applicant must request from FDA before 
submitting the pre-submission;
    B. Cover letter accompanying the pre-submission, which includes a 
statement of justification for the expedited review request, a 
statement of inspection readiness, a statement identifying the 
Reference Listed Drug, and the anticipated date of the applicant's ANDA 
submission; and
    C. Certification statement to be submitted with the applicant's 
ANDA stating either that the applicant has made no changes to the pre-
submitted facility information, or that the only change was made to 
exclude a facility as described in 505(j)(11)(B) of the FD&C Act. 
(Changes other than those permitted under 505(j)(11)(B) of the FD&C Act 
should be identified in the ANDA cover letter. The applicant will also 
need to confirm the accuracy of the information provided in the Form 
FDA 356h submitted with the ANDA, and update accordingly.)
    Section VI of the draft guidance describes the format used to 
submit the pre-submission of facility information, which is the 
electronic Common Technical Document (eCTD) format. Further, as 
explained in section V of the draft guidance, the pre-submission must 
be submitted not later than 60 days prior to the planned ANDA 
submission.
    We estimate that a total of approximately 220 applicants (``number 
of respondents'' in table 1) will submit annually approximately 275 
pre-submissions as described above and in the draft guidance (``total 
annual responses'' in table 1). We estimate that preparing and 
submitting the portion of each pre-submission that is not already 
addressed under approved control numbers covering ANDA submissions will 
take approximately 1.1 hours (``average burden per response'' in table 
1). This includes time spent preparing and submitting a cover letter 
accompanying the pre-submission of facility information. We estimate 
that approximately 10 percent of applicants will submit statements 
notifying the Agency that the applicant has decided not to submit an 
ANDA, and we have incorporated the estimated time to prepare and submit 
such a statement in table 1.
    We estimate that approximately 198 applicants will submit annually 
approximately 248 certifications (``total annual responses'' in table 
1) verifying either that the applicant has made no changes to the pre-
submitted facility information, or that the only change was made to 
exclude a facility as described in 505(j)(11)(B) of the FD&C Act. We 
estimate that preparing and submitting each certification will take 
approximately 4 hours (``average burden per response'' in table 1).
    We base our estimates for the number of applicants and the number 
of pre-submissions on information from our database of annual ANDA 
submissions, on the criteria set forth in the Agency's Manual of 
Policies and Procedures 5240.3, Prioritization of the Review of 
Original ANDAs, Amendments, and Supplements (available at: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM407849.pdf), and the number of ``priority'' submissions. Our 
estimate of the time applicants would need to prepare and submit the 
portions of each pre-submission not already addressed under approved 
control numbers covering

[[Page 51424]]

ANDA submissions, as well as the pre-submission certification statement 
(referenced in table 1), takes into consideration that much of this 
content is related to information already gathered for the ANDA 
submission. We invite comments on these estimates.

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Pre-Submission of Facility                   220            1.25             275             1.1             303
 Information....................
Certification statement                      198            1.25             248               4             990
 submitted with the ANDA........
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. 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: October 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24099 Filed 11-3-17; 8:45 am]
 BILLING CODE 4164-01-P