[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54357-54359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0313]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry, Researchers, Patient Groups, 
and Food and Drug Administration Staff on Meetings With the Office of 
Orphan Products Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the Guidance for Industry, Researchers, 
Patient Groups, and FDA Staff on Meetings with the Office of Orphan 
Products Development.

DATES: Submit either electronic or written comments on the collection 
of information by January 16, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 16, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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-2014-D-0313 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry, 
Researchers, Patient Groups, and Food and Drug Administration Staff on 
Meetings with the Office of Orphan Products Development.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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

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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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under 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, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments 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.

Guidance for Industry, Researchers, Patient Groups, and Food and Drug 
Administration Staff on Meetings With the Office of Orphan Products 
Development

OMB Control Number 0910-0787--Extension

    This information collection supports Agency guidance regarding 
staff meetings with the Office of Orphan Products Development. Each 
year, the Office of Orphan Products Development (OOPD) staff 
participates in meetings with stakeholders who seek guidance or 
clarification relating to orphan drug or humanitarian use device (HUD) 
designation requests, OOPD grant programs, or other rare disease 
issues. These meetings can be ``informal'' or ``formal'' and help build 
a common understanding on FDA's thoughts on orphan products, which may 
include drugs, biological products, devices, or medical foods for a 
rare disease or condition. These meetings may represent critical points 
in the orphan product development process and may even have an impact 
on the eventual availability of products for patients with rare 
diseases and conditions. It is important that these meetings be 
scheduled within a reasonable time, conducted effectively, and 
documented where appropriate.
    Topics addressed in this guidance include: (1) Clarification of 
what constitutes an ``informal'' or ``formal'' meeting, (2) program 
areas within OOPD that may be affected by this draft guidance, (3) 
procedures for requesting and scheduling meetings with OOPD, (4) 
description of what constitutes a meeting package, and (5) procedures 
for the conduct and documentation of meetings with OOPD. This guidance 
provides consistent procedures to promote well-managed meetings between 
OOPD and stakeholders.
    Burden estimate. Table 1 of this document provides an estimate of 
the annual reporting burden associated with the recommendation found in 
the guidance.
    Request for a meeting. Based upon information collected from OOPD 
program areas, approximately 2,332 informal and 51 formal meetings were 
requested with OOPD in fiscal year (FY) 2016 regarding orphan drug 
designation requests, HUD designation requests, rare pediatric disease 
designation requests, funding opportunities through the Orphan Products 
Grants Program and the Pediatric Device Consortia Grants Program, and 
orphan product patient-related issues. FDA anticipates that the number 
of meeting requests and stakeholders will remain the same or will only 
slightly increase and therefore estimates the total number of meeting 
requests will be 2,383 annually (2332 informal and 51 formal meetings). 
The hours per response, which is the estimated number of hours that a 
stakeholder would spend preparing the information to be submitted with 
a meeting request in accordance with the guidance, is estimated to be 
approximately 3 hours for informal meetings and approximately 10 hours 
for formal meetings. Based on FDA's experience, the Agency expects that 
it will take stakeholders this amount of time to gather and copy brief 
statements about the product and a description of the purpose and 
details of the meeting. Therefore, the Agency estimates that 
stakeholders will spend 7,506 hours per year (6,996 hours for informal 
meetings and 510 hours for formal meetings) preparing meeting requests 
to OOPD regarding orphan drug designation requests, HUD designation 
requests, rare pediatric disease designation requests, funding 
opportunities through the Orphan Products Grants Program and the 
Pediatric Device Consortia Grants Program, and orphan product patient-
related issues.
    Meeting packages. Based upon information collected from OOPD 
program areas, OOPD held approximately 51 formal meetings in FY 2016 
regarding orphan drug designation requests, HUD designation requests, 
rare pediatric disease designation requests, funding opportunities 
through the Orphan Products Grants Program and the Pediatric Device 
Consortia Grants Program, and orphan product patient-related issues. 
FDA anticipates that the number of formal meetings, and therefore 
meeting packages, may increase only slightly as a result of this 
guidance; thus, the Agency estimates that the total responses will be 
51 annually. As stated previously, it is current practice for 
stakeholders to submit meeting packages to the Agency in advance of any 
such formal meeting. The hours per response, which is the

[[Page 54359]]

estimated number of hours that a stakeholder would spend preparing the 
meeting package in accordance with this guidance, is estimated to be 
approximately 18 hours. Based on FDA's experience, the Agency expects 
it will take stakeholders this amount of time to gather and copy brief 
statements about the product, a description of details for the 
anticipated meeting, and data and information that generally would 
already have been compiled for submission to the Agency. Therefore, the 
Agency estimates that stakeholders will spend 918 hours per year 
submitting meeting packages to the Agency prior to a formal meeting 
regarding orphan drug designation requests, HUD designation requests, 
rare pediatric disease designation requests, funding opportunities 
through the Orphan Products Grants Program and the Pediatric Device 
Consortia Grants Program, and orphan product patient-related issues.
    Draft meeting minutes. Based upon information collected from OOPD 
program areas, OOPD received approximately 51 draft meeting minutes for 
formal meetings and 23 draft meeting minutes for informal meetings in 
FY 2016 regarding orphan drug designation requests, HUD designation 
requests, rare pediatric disease designation requests, funding 
opportunities through the Orphan Products Grants Program and the 
Pediatric Device Consortia Grants Program, and orphan product patient-
related issues. FDA anticipates that the number of stakeholders 
submitting draft meeting minutes may remain the same or increase only 
slightly; thus, the Agency estimates that the total number of 
respondents will be 74 annually. As stated previously, it is current 
practice for stakeholders to submit draft meeting minutes to the Agency 
after all formal meetings and certain informal meetings. The hours per 
response, which is the estimated number of hours that a stakeholder 
would spend preparing draft meeting minutes in accordance with this 
guidance, is estimated to be approximately 8 hours. Based on FDA's 
experience, the Agency expects it will take stakeholders this amount of 
time to summarize the meeting discussion points, agreements, 
disagreements, and action items. Therefore, the Agency estimates that 
stakeholders will spend 592 hours per year submitting draft meeting 
minutes to the Agency documenting the meeting outcomes, agreements, 
disagreements, and action items as followup to all formal and certain 
informal meetings.
    FDA therefore estimates the burden of this collection of 
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
 Meeting requests, packages and      Number of     responses per   Total annual     burden per      Total hours
             minutes                respondents     respondent       responses       response
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Meeting requests (informal).....           2,332               1           2,332               3           6,996
Meeting requests (formal).......              51               1              51              10             510
Meeting packages................              51               1              51              18             918
Meeting minutes.................              74               1              74               8             592
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    Total.......................  ..............  ..............  ..............  ..............           9,016
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since the last OMB approval, we have increased our estimate by 832 
hours and 229 respondents in parallel to an increase in overall orphan 
drug designation submissions and to correspond meeting requests to the 
Office of Orphan Products Development.

    Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24926 Filed 11-16-17; 8:45 am]
 BILLING CODE 4164-01-P


