82 FR 54357 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 221 (November 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 221 (November 17, 2017)
| Page Range | 54357-54359 | |
| FR Document | 2017-24926 |
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)] [Notices] [Pages 54357-54359] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24926] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 [[Page 54358]] 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.thefederalregister.org/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\ ---------------------------------------------------------------------------------------------------------------- Number of Average Meeting requests, packages and Number of responses per Total annual burden per Total hours minutes respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 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 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 9,016 ---------------------------------------------------------------------------------------------------------------- \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
![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54357
burden estimate to include the DEPARTMENT OF HEALTH AND comment does not include any
methodology or reasoning used to do so. HUMAN SERVICES confidential information that you or a
Based on our experience with the third party may not wish to be posted,
Food and Drug Administration such as medical information, your or
information collection over the past 3
anyone else’s Social Security number, or
years, we estimate that 55 respondents [Docket No. FDA–2014–D–0313]
confidential business information, such
will submit 1 premarket notification
Agency Information Collection as a manufacturing process. Please note
each. We estimate that extracting and that if you include your name, contact
summarizing the relevant information Activities; Proposed Collection;
Comment Request; Guidance for information, or other information that
from what exists in the company’s files identifies you in the body of your
Industry, Researchers, Patient Groups,
and presenting it in a format that meets comments, that information will be
and Food and Drug Administration
the requirements of § 190.6 will take posted on https://www.regulations.gov.
Staff on Meetings With the Office of
approximately 20 hours of work per
Orphan Products Development • If you want to submit a comment
notification. We have carefully with confidential information that you
considered the burden associated with AGENCY: Food and Drug Administration, do not wish to be made available to the
the premarket notification requirement HHS. public, submit the comment as a
and believe that estimates greater than ACTION: Notice. written/paper submission and in the
20 hours are likely to include burden manner detailed (see ‘‘Written/Paper
associated with researching and SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
generating safety data for a new dietary Administration (FDA or Agency) is
Written/Paper Submissions
ingredient. We also believe that the announcing an opportunity for public
comment on the proposed collection of Submit written/paper submissions as
burden of the premarket notification
certain information by the Agency. follows:
requirement on industry is minimal and • Mail/Hand delivery/Courier (for
Under the Paperwork Reduction Act of
reasonable because we are requesting written/paper submissions): Dockets
1995 (PRA), Federal Agencies are
only safety and identity information that Management Staff (HFA–305), Food and
required to publish notice in the
the manufacturer or distributor should Drug Administration, 5630 Fishers
Federal Register concerning each
already have developed to satisfy itself proposed collection of information, Lane, Rm. 1061, Rockville, MD 20852.
that a dietary supplement containing a including each proposed extension of an • For written/paper comments
new dietary ingredient is in compliance existing collection of information, and submitted to the Dockets Management
with the FD&C Act. Under section to allow 60 days for public comment in Staff, FDA will post your comment, as
413(a)(2) of the FD&C Act, a dietary response to the notice. This notice well as any attachments, except for
supplement that contains a new dietary solicits comments on the Guidance for information submitted, marked and
ingredient is deemed to be adulterated Industry, Researchers, Patient Groups, identified, as confidential, if submitted
unless there is a history of use or other and FDA Staff on Meetings with the as detailed in ‘‘Instructions.’’
evidence of safety establishing that the Office of Orphan Products Instructions: All submissions received
new dietary ingredient will reasonably Development. must include the Docket No. FDA–
be expected to be safe under the 2014–D–0313 for ‘‘Agency Information
DATES: Submit either electronic or Collection Activities; Proposed
conditions of use recommended or written comments on the collection of Collection; Comment Request; Guidance
suggested in the labeling of the dietary information by January 16, 2018. for Industry, Researchers, Patient
supplement. This requirement is
ADDRESSES: You may submit comments Groups, and Food and Drug
separate from and additional to the
as follows. Please note that late, Administration Staff on Meetings with
requirement to submit a premarket untimely filed comments will not be the Office of Orphan Products
notification for the new dietary considered. Electronic comments must Development.’’ Received comments,
ingredient. FDA’s regulation on new be submitted on or before January 16, those filed in a timely manner (see
dietary ingredient notifications, 2018. The https://www.regulations.gov ADDRESSES), will be placed in the docket
§ 190.6(a), requires the manufacturer or electronic filing system will accept and, except for those submitted as
distributor of the dietary supplement or comments until midnight Eastern Time ‘‘Confidential Submissions,’’ publicly
of the new dietary ingredient to submit at the end of January 16, 2018. viewable at https://www.regulations.gov
to FDA the information that forms the Comments received by mail/hand or at the Dockets Management Staff
basis for its conclusion that a dietary delivery/courier (for written/paper between 9 a.m. and 4 p.m., Monday
supplement containing the new dietary submissions) will be considered timely through Friday.
ingredient will reasonably be expected if they are postmarked or the delivery • Confidential Submissions—To
to be safe. Thus, § 190.6 only requires service acceptance receipt is on or submit a comment with confidential
the manufacturer or distributor to before that date. information that you do not wish to be
extract and summarize information that made publicly available, submit your
Electronic Submissions comments only as a written/paper
should have already been developed to
meet the safety requirement in section Submit electronic comments in the submission. You should submit two
413(a)(2) of the FD&C Act. following way: copies total. One copy will include the
• Federal eRulemaking Portal: information you claim to be confidential
Dated: November 9, 2017. https://www.regulations.gov. Follow the with a heading or cover note that states
sradovich on DSK3GMQ082PROD with NOTICES
Anna K. Abram, instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
Deputy Commissioner for Policy, Planning, Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The
Legislation, and Analysis. including attachments, to https:// Agency will review this copy, including
[FR Doc. 2017–24925 Filed 11–16–17; 8:45 am] www.regulations.gov will be posted to the claimed confidential information, in
BILLING CODE 4164–01–P the docket unchanged. Because your its consideration of comments. The
comment will be made public, you are second copy, which will have the
solely responsible for ensuring that your claimed confidential information
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![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54359
estimated number of hours that a Program, and orphan product patient- for stakeholders to submit draft meeting
stakeholder would spend preparing the related issues. minutes to the Agency after all formal
meeting package in accordance with this Draft meeting minutes. Based upon meetings and certain informal meetings.
guidance, is estimated to be information collected from OOPD The hours per response, which is the
approximately 18 hours. Based on program areas, OOPD received estimated number of hours that a
FDA’s experience, the Agency expects it approximately 51 draft meeting minutes stakeholder would spend preparing
will take stakeholders this amount of for formal meetings and 23 draft draft meeting minutes in accordance
time to gather and copy brief statements meeting minutes for informal meetings with this guidance, is estimated to be
about the product, a description of in FY 2016 regarding orphan drug approximately 8 hours. Based on FDA’s
details for the anticipated meeting, and designation requests, HUD designation experience, the Agency expects it will
data and information that generally requests, rare pediatric disease take stakeholders this amount of time to
would already have been compiled for designation requests, funding summarize the meeting discussion
submission to the Agency. Therefore, opportunities through the Orphan points, agreements, disagreements, and
the Agency estimates that stakeholders Products Grants Program and the action items. Therefore, the Agency
will spend 918 hours per year Pediatric Device Consortia Grants estimates that stakeholders will spend
submitting meeting packages to the Program, and orphan product patient- 592 hours per year submitting draft
Agency prior to a formal meeting related issues. FDA anticipates that the meeting minutes to the Agency
regarding orphan drug designation number of stakeholders submitting draft documenting the meeting outcomes,
requests, HUD designation requests, rare meeting minutes may remain the same agreements, disagreements, and action
pediatric disease designation requests, or increase only slightly; thus, the items as followup to all formal and
funding opportunities through the Agency estimates that the total number certain informal meetings.
Orphan Products Grants Program and of respondents will be 74 annually. As FDA therefore estimates the burden of
the Pediatric Device Consortia Grants stated previously, it is current practice this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Meeting requests, packages and minutes responses per burden per Total hours
respondents responses
respondent response
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
Total .............................................................................. ........................ ........................ ........................ ........................ 9,016
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last OMB approval, we have SUMMARY: The Food and Drug Comments received by mail/hand
increased our estimate by 832 hours and Administration (FDA or Agency) is delivery/courier (for written/paper
229 respondents in parallel to an announcing an opportunity for public submissions) will be considered timely
increase in overall orphan drug comment on the proposed collection of if they are postmarked or the delivery
designation submissions and to certain information by the Agency. service acceptance receipt is on or
correspond meeting requests to the Under the Paperwork Reduction Act of before that date.
Office of Orphan Products 1995 (PRA), Federal Agencies are Electronic Submissions
Development. required to publish notice in the
Federal Register concerning each Submit electronic comments in the
Dated: November 9, 2017.
proposed collection of information following way:
Anna K. Abram,
including each proposed extension of an • Federal eRulemaking Portal:
Deputy Commissioner for Policy, Planning, https://www.regulations.gov. Follow the
Legislation, and Analysis. existing collection of information, and
to allow 60 days for public comment in instructions for submitting comments.
[FR Doc. 2017–24926 Filed 11–16–17; 8:45 am] Comments submitted electronically,
response to the notice. This notice
BILLING CODE 4164–01–P
solicits comments on FDA recalls for including attachments, to https://
human drugs, biological products, www.regulations.gov will be posted to
devices, animal drugs, food, cosmetics, the docket unchanged. Because your
DEPARTMENT OF HEALTH AND comment will be made public, you are
HUMAN SERVICES and tobacco.
solely responsible for ensuring that your
DATES: Submit either electronic or comment does not include any
Food and Drug Administration written comments on the collection of confidential information that you or a
[Docket No. FDA–2017–N–6175] information by January 16, 2018. third party may not wish to be posted,
ADDRESSES: You may submit comments such as medical information, your or
Agency Information Collection as follows. Please note that late, anyone else’s Social Security number, or
sradovich on DSK3GMQ082PROD with NOTICES
Activities; Proposed Collection; untimely filed comments will not be confidential business information, such
Comment Request; Food and Drug considered. Electronic comments must as a manufacturing process. Please note
Administration Recall Regulations be submitted on or before January 16, that if you include your name, contact
AGENCY: Food and Drug Administration, 2018. The https://www.regulations.gov information, or other information that
HHS. electronic filing system will accept identifies you in the body of your
comments until midnight Eastern Time comments, that information will be
ACTION: Notice.
at the end of January 16, 2018. posted on https://www.regulations.gov.
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Document Created: 2017-11-17 05:15:11
Document Modified: 2017-11-17 05:15:11
| 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. | |
| Dates | Submit either electronic or written comments on the collection of information by January 16, 2018. | |
| 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] | |
| FR Citation | 82 FR 54357 |
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