83 FR 8880 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 41 (March 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 41 (March 1, 2018)
| Page Range | 8880-8881 | |
| FR Document | 2018-04153 |
[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)] [Notices] [Pages 8880-8881] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04153] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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\ ---------------------------------------------------------------------------------------------------------------- Number of Meeting requests, packages and Number of responses per Total annual Average burden Total hours minutes respondents respondent responses per 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 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
![8880 Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices
Considering all applicable factors Dated: February 26, 2018. Guidance for Industry, Researchers,
under 306(c)(3) of the FD&C Act, OSI George M. Warren, Patient Groups, and Food and Drug
concurs with ORA’s proposal that a 5- Director, Office of Scientific Integrity. Administration Staff on Meetings With
year period of debarment for each [FR Doc. 2018–04195 Filed 2–28–18; 8:45 am]
the Office of Orphan Products
offense is warranted. On this record, Development
BILLING CODE 4164–01–P
OSI finds that the nature and OMB Control Number 0910–0787—
seriousness of the offenses and the Extension
nature and extent of Meunerie DEPARTMENT OF HEALTH AND This information collection supports
Sawyerville management’s participation HUMAN SERVICES Agency guidance regarding staff
in the offenses are factors weighing
meetings with the Office of Orphan
heavily in favor of debarment. For the Food and Drug Administration Products Development (OOPD). Each
reasons already discussed, even year, the OOPD staff participates in
assuming Meunerie Sawyerville has [Docket No. FDA–2014–D–0313] meetings with stakeholders who seek
discontinued using monensin in its guidance or clarification relating to
operations, OSI finds that operational Agency Information Collection orphan drug or humanitarian use device
change insufficient under section Activities; Submission for Office of (HUD) designation requests, OOPD grant
306(c)(3)(D) to demonstrate correction of Management and Budget Review; programs, or other rare disease issues.
the causes of these offenses and to Comment Request; Guidance for These meetings can be ‘‘informal’’ or
provide reasonable assurances that the Industry, Researchers, Patient Groups, ‘‘formal’’ and help build a common
offenses will not recur. Further, even and Food and Drug Administration understanding on FDA’s thoughts on
after taking into account Meunerie Staff on Meetings With the Office of orphan products, which may include
Sawyerville’s guilty plea under section Orphan Products Development drugs, biological products, devices, or
306(c)(3)(C), OSI finds that Meunerie medical foods for a rare disease or
Sawyerville’s conduct related to this AGENCY: Food and Drug Administration, condition. These meetings may
consideration weighs in favor of HHS. represent critical points in the orphan
debarment. Although Meunerie product development process and may
ACTION: Notice. even have an impact on the eventual
Sawyerville’s lack of a prior conviction
under 306(c)(3)(F) is a factor weighing availability of products for patients with
against debarment, this consideration is SUMMARY: The Food and Drug rare diseases and conditions. It is
substantially outweighed by the nature Administration (FDA) is announcing important that these meetings be
and seriousness of the offenses, the that a proposed collection of scheduled within a reasonable time,
nature and extent of management’s information has been submitted to the conducted effectively, and documented
participation in the offenses, and the Office of Management and Budget where appropriate.
(OMB) for review and clearance under Topics addressed in this guidance
nature and extent of voluntary steps to include: (1) Clarification of what
mitigate the impact of the offenses on the Paperwork Reduction Act of 1995.
constitutes an ‘‘informal’’ or ‘‘formal’’
the public. Therefore, considering all of DATES: Fax written comments on the meeting, (2) program areas within OOPD
these factors together and the record as collection of information by April 2, that may be affected by this draft
a whole, OSI finds that a 5-year period 2018. guidance, (3) procedures for requesting
of debarment is warranted for each and scheduling meetings with OOPD,
offense. ADDRESSES: To ensure that comments on (4) description of what constitutes a
the information collection are received, meeting package, and (5) procedures for
Therefore, the Director of OSI, under
OMB recommends that written the conduct and documentation of
section 306(b)(3)(A) of the FD&C Act
comments be faxed to the Office of meetings with OOPD. This guidance
and under authority delegated to him by
Information and Regulatory Affairs, provides consistent procedures to
the Commissioner of Food and Drugs,
OMB, Attn: FDA Desk Officer, Fax: 202– promote well-managed meetings
finds that Meunerie Sawyerville has
been convicted of a felony for conduct 395–7285, or emailed to oira_ between OOPD and stakeholders.
relating to the importation of food into submission@omb.eop.gov. All Burden estimate. Table 1 provides an
the United States. FDA has considered comments should be identified with the estimate of the annual reporting burden
the relevant factors listed in section OMB control number 0910–0787. Also associated with the recommendations
include the FDA docket number found found in the guidance.
306(c)(3) of the FD&C Act and
in brackets in the heading of this Request for a meeting. Based upon
determined that a debarment of 5 years information collected from OOPD
is appropriate for each of these felony document.
program areas, approximately 2,332
offenses. These periods will run FOR FURTHER INFORMATION CONTACT: informal and 51 formal meetings were
concurrently under section 306(c)(2)(A). Amber Sanford, Office of Operations, requested with OOPD in fiscal year (FY)
As a result of the foregoing findings, Food and Drug Administration, Three 2016 regarding orphan drug designation
Meunerie Sawyerville is debarred for a White Flint North, 10A–12M, 11601 requests, HUD designation requests, rare
period of 5 years from importing articles Landsdown St., North Bethesda, MD pediatric disease designation requests,
of food or offering such articles for 20852, 301–796–8867, PRAStaff@ funding opportunities through the
import into the United States, fda.hhs.gov. Orphan Products Grants Program and
amozie on DSK30RV082PROD with NOTICES
applicable (see DATES). Under section the Pediatric Device Consortia Grants
301(cc) of the FD&C Act, the importing SUPPLEMENTARY INFORMATION: In Program, and orphan product patient-
or offering for import into the United compliance with 44 U.S.C. 3507, FDA related issues. FDA anticipates that the
States of an article of food by, with the has submitted the following proposed number of meeting requests and
assistance of, or at the direction of collection of information to OMB for stakeholders will remain the same or
Meunerie Sawyerville is a prohibited review and clearance. will slightly increase and therefore
act. estimates the total number of meeting
VerDate Sep<11>2014 17:26 Feb 28, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\01MRN1.SGM 01MRN1](https://thefederalregister.org/doc/83_FR_8921/page/1.svg)
![Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices 8881
requests will be 2,383 annually (2,332 therefore meeting packages, will remain designation requests, funding
informal and 51 formal meetings). The the same; thus, the Agency estimates opportunities through the Orphan
hours per response, which is the that the total responses will be 51 Products Grants Program and the
estimated number of hours that a annually. As stated previously, it is Pediatric Device Consortia Grants
stakeholder would spend preparing the current practice for stakeholders to Program, and orphan product patient-
information to be submitted with a submit meeting packages to the Agency related issues. FDA anticipates that the
meeting request in accordance with the in advance of any such formal meeting. number of stakeholders submitting draft
guidance, is estimated to be The hours per response, which is the meeting minutes will likely remain the
approximately 3 hours for informal estimated number of hours that a same; thus, the Agency estimates that
meetings and approximately 10 hours stakeholder would spend preparing the the total number of respondents will be
for formal meetings. Based on FDA’s meeting package in accordance with this 74 annually. As stated previously, it is
experience, the Agency expects that it guidance, is estimated to be current practice for stakeholders to
will take stakeholders this amount of approximately 18 hours. Based on submit draft meeting minutes to the
time to gather and copy brief statements FDA’s experience, the Agency expects it Agency after all formal meetings and
about the product and a description of will take stakeholders this amount of certain informal meetings. The hours
the purpose and details of the meeting. time to gather and copy brief statements per response, which is the estimated
Therefore, the Agency estimates that about the product, a description of number of hours that a stakeholder
stakeholders will spend 7,506 hours per details for the anticipated meeting, and would spend preparing draft meeting
year (6,996 hours for informal meetings data and information that generally minutes in accordance with the
and 510 hours for formal meetings) would already have been compiled for recommendations of the guidance, is
preparing meeting requests to OOPD submission to the Agency. Therefore, estimated to be approximately 8 hours.
regarding orphan drug designation the Agency estimates that stakeholders Based on FDA’s experience, the Agency
requests, HUD designation requests, rare will spend 918 hours per year expects it will take stakeholders this
pediatric disease designation requests, submitting meeting packages to the amount of time to summarize the
funding opportunities through the Agency prior to a formal meeting meeting discussion points, agreements,
Orphan Products Grants Program and regarding orphan drug designation disagreements, and action items.
the Pediatric Device Consortia Grants requests, HUD designation requests, rare Therefore, the Agency estimates that
Program, and orphan product patient- pediatric disease designation requests, stakeholders will spend 592 hours per
related issues. funding opportunities through the year submitting draft meeting minutes
Meeting packages. Based upon Orphan Products Grants Program and to the Agency documenting the meeting
information collected from OOPD the Pediatric Device Consortia Grants outcomes, agreements, disagreements,
program areas, OOPD held Program, and orphan product patient- and action items as followup to all
approximately 51 formal meetings in FY related issues. formal and certain informal meetings.
2016 regarding orphan drug designation Draft meeting minutes. Based upon
requests, HUD designation requests, rare information collected from OOPD In the Federal Register of November
pediatric disease designation requests, program areas, OOPD received 17, 2017 (82 FR 54357), FDA published
funding opportunities through the approximately 51 draft meeting minutes a 60-day notice requesting public
Orphan Products Grants Program and for formal meetings and 23 draft comment on the proposed collection of
the Pediatric Device Consortia Grants meeting minutes for informal meetings information. No comments were
Program, and orphan product patient- in FY 2016 regarding orphan drug received.
related issues. FDA anticipates that the designation requests, HUD designation FDA therefore estimates the burden of
number of formal meetings, and requests, rare pediatric disease 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 designation submissions and the Dated: February 23, 2018.
increased our estimate by 832 hours and corresponding meeting requests to the Leslie Kux,
229 respondents in parallel to an OOPD. Associate Commissioner for Policy.
increase in overall orphan drug [FR Doc. 2018–04153 Filed 2–28–18; 8:45 am]
BILLING CODE 4164–01–P
amozie on DSK30RV082PROD with NOTICES
VerDate Sep<11>2014 17:26 Feb 28, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 9990 E:\FR\FM\01MRN1.SGM 01MRN1](https://thefederalregister.org/doc/83_FR_8921/page/2.svg)
Document Created: 2018-02-28 23:58:35
Document Modified: 2018-02-28 23:58:35
| 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 | Fax written comments on the collection of information by April 2, 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 | 83 FR 8880 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR