[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Notices]
[Pages 8880-8881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04153]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
2, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0787. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 (OOPD). 
Each year, the 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 provides an estimate of the annual 
reporting burden associated with the recommendations 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 
slightly increase and therefore estimates the total number of meeting

[[Page 8881]]

requests will be 2,383 annually (2,332 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, will remain the same; 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 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 will likely remain the same; 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 the recommendations of the 
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.
    In the Federal Register of November 17, 2017 (82 FR 54357), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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
 Meeting requests, packages and      Number of     responses per   Total annual   Average burden    Total hours
             minutes                respondents     respondent       responses     per 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 the corresponding meeting requests to 
the OOPD.

    Dated: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04153 Filed 2-28-18; 8:45 am]
BILLING CODE 4164-01-P