83 FR 56349 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Surveys and Interviews With Investigational New Drug Sponsors To Assess Current Communication Practices With Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 219 (November 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 219 (November 13, 2018)
| Page Range | 56349-56350 | |
| FR Document | 2018-24608 |
[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)] [Notices] [Pages 56349-56350] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24608] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2970] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Surveys and Interviews With Investigational New Drug Sponsors To Assess Current Communication Practices With Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act 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 December 13, 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-NEW and title ``Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. Surveys and Interviews With Investigational New Drug (IND) Sponsors To Assess Current Communication Practices With Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act (PDUFA VI) OMB Control Number 0910-NEW In Fiscal Year 2017, FDA published guidance on communications between FDA review staff and drug sponsors during the IND phase of drug development. As part of PDUFA VI, FDA committed to a third-party assessment of current IND-phase communication practices, which should reflect this guidance. The contractor for the assessment of IND communication practices is Eastern Research Group, Inc. (ERG). Therefore, in accordance with the PDUFA VI Commitment Letter, FDA proposes to have ERG conduct surveys and interviews with sponsors of up to 150 active commercial INDs as follows:For each formal meeting between FDA review staff and active commercial IND sponsors during the assessment period, send a survey to the sponsor to solicit specific feedback about communication practices employed for that meeting. For the purpose of this assessment, formal meetings are Type A, B, B (End of Phase), and C meetings during the IND phase of drug development. For each active commercial IND in the assessment, conduct an interview with the sponsor to obtain broader feedback about all communications with FDA review staff during the study period, including telephone and email interactions in addition to meetings. The purpose of this information collection is to understand active commercial IND sponsor perspectives on communication during drug development with a focus on what is working well, ongoing challenges and pain points, lessons learned, and opportunities for improvement. The contractor will develop anonymized aggregated summaries of survey and interview responses, analyze this information to identify common themes, consider these results along with IND data and feedback from FDA review staff to develop a set of findings and recommendations, and prepare a report to be published on FDA's website. The contractor will keep information collected private; ERG will not disclose personally identifying information to FDA or any other party. In the Federal Register of August 16, 2018 (83 FR 40771), FDA published a 60-day notice requesting public [[Page 56350]] comment on the proposed collection of information. No comments were received. The number of commercial INDs with activity is approximately 4,000 per year. ERG will interview 1 to 3 sponsor representatives at a time for up to 150 INDs during the annual assessment period. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of respondent Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- IND sponsors: Surveys........................ 150 1 150 0.17 (10 minutes)........................ 25.50 IND sponsors: Interviews..................... 450 1 450 1.5...................................... 675 ---------------------------------------------------------------------------------------------------------- Total.................................... .............. .............. .............. ......................................... 700.50 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates that it will take each IND sponsor a maximum of 10 minutes to complete a survey. Up to 150 respondents will take part in the survey, yielding a maximum burden of 25.5 hours. FDA estimates that it will take each IND sponsor up to 90 minutes to respond to requests for interviews and participate in interviews. Up to 450 respondents will take part in interviews, yielding a maximum burden of 675 hours. FDA's burden estimates are based on experience with information collections for similar types of PDUFA-related assessments. Dated: November 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-24608 Filed 11-9-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 56349
QualificationPublicMeeting@ DEPARTMENT OF HEALTH AND Surveys and Interviews With
fda.hhs.gov no later than Friday, HUMAN SERVICES Investigational New Drug (IND)
November 30, 2018, by 11:59 p.m. Sponsors To Assess Current
Eastern Time. Food and Drug Administration Communication Practices With Food
and Drug Administration Review Staff
Requests for Oral Presentations: There
[Docket No. FDA–2018–N–2970] Under the Sixth Authorization of the
will be time allotted during the public
Prescription Drug User Fee Act (PDUFA
meeting for open public comment. VI)
Signup for this session will be on a first- Agency Information Collection
come, first-served basis; there will be a Activities; Submission for Office of OMB Control Number 0910–NEW
time limit on the day of the workshop. Management and Budget Review;
In Fiscal Year 2017, FDA published
Individuals and organizations with Comment Request; Surveys and
guidance on communications between
common interests are urged to Interviews With Investigational New FDA review staff and drug sponsors
consolidate or coordinate their Drug Sponsors To Assess Current during the IND phase of drug
presentations and request time for a Communication Practices With Food development. As part of PDUFA VI,
joint presentation. No commercial or and Drug Administration Review Staff FDA committed to a third-party
promotional material will be permitted Under the Sixth Authorization of the assessment of current IND-phase
to be presented or distributed at the Prescription Drug User Fee Act communication practices, which should
public meeting. reflect this guidance. The contractor for
AGENCY: Food and Drug Administration, the assessment of IND communication
Webcast Information: FDA plans to HHS. practices is Eastern Research Group, Inc.
provide a free, live webcast of this (ERG).
public meeting. The link to the public ACTION: Notice.
Therefore, in accordance with the
meeting is https://collaboration.fda.gov/ PDUFA VI Commitment Letter, FDA
r7zu2p7t3ab, which will not be SUMMARY: The Food and Drug proposes to have ERG conduct surveys
accessible until 45 minutes prior to the Administration (FDA) is announcing and interviews with sponsors of up to
meeting. that a proposed collection of 150 active commercial INDs as follows:
FDA plans to post archived webcasts
information has been submitted to the • For each formal meeting between
Office of Management and Budget FDA review staff and active commercial
after the meeting; archived webcasts (OMB) for review and clearance under IND sponsors during the assessment
will be available. the Paperwork Reduction Act of 1995. period, send a survey to the sponsor to
If you have never attended a Connect solicit specific feedback about
Pro event before, test your connection at DATES: Fax written comments on the
communication practices employed for
https://collaboration.fda.gov/common/ collection of information by December
that meeting. For the purpose of this
help/en/support/meeting_test.htm. To 13, 2018.
assessment, formal meetings are Type
get a quick overview of the Connect Pro ADDRESSES: To ensure that comments on A, B, B (End of Phase), and C meetings
program, visit https://www.adobe.com/ the information collection are received, during the IND phase of drug
go/connectpro_overview. FDA has OMB recommends that written development.
verified the website addresses in this comments be faxed to the Office of • For each active commercial IND in
document, as of the date this document Information and Regulatory Affairs, the assessment, conduct an interview
publishes in the Federal Register, but OMB, Attn: FDA Desk Officer, Fax: 202– with the sponsor to obtain broader
websites are subject to change over time. 395–7285, or emailed to oira_ feedback about all communications with
submission@omb.eop.gov. All FDA review staff during the study
Transcripts: Please be advised that as period, including telephone and email
soon as a transcript of the public comments should be identified with the
interactions in addition to meetings.
meeting is available, it will be accessible OMB control number 0910–NEW and The purpose of this information
at https://www.regulations.gov. It may title ‘‘Surveys and Interviews with collection is to understand active
be viewed at the Dockets Management Investigational New Drug Sponsors to commercial IND sponsor perspectives
Staff (see ADDRESSES). Assess Current Communication on communication during drug
Practices with Food and Drug development with a focus on what is
Dated: November 6, 2018.
Administration Review Staff Under the working well, ongoing challenges and
Leslie Kux, Sixth Authorization of the Prescription pain points, lessons learned, and
Associate Commissioner for Policy. Drug User Fee Act.’’ Also include the opportunities for improvement. The
[FR Doc. 2018–24656 Filed 11–9–18; 8:45 am] FDA docket number found in brackets contractor will develop anonymized
BILLING CODE 4164–01–P in the heading of this document. aggregated summaries of survey and
FOR FURTHER INFORMATION CONTACT: Ila interview responses, analyze this
information to identify common themes,
S. Mizrachi, Office of Operations, Food
consider these results along with IND
and Drug Administration, Three White
data and feedback from FDA review
Flint North, 10A–12M, 11601 staff to develop a set of findings and
Landsdown St., North Bethesda, MD recommendations, and prepare a report
20852, 301–796–7726, PRAStaff@ to be published on FDA’s website. The
amozie on DSK3GDR082PROD with NOTICES1
fda.hhs.gov. contractor will keep information
SUPPLEMENTARY INFORMATION: In collected private; ERG will not disclose
compliance with 44 U.S.C. 3507, FDA personally identifying information to
FDA or any other party.
has submitted the following proposed In the Federal Register of August 16,
collection of information to OMB for 2018 (83 FR 40771), FDA published a
review and clearance. 60-day notice requesting public
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![56350 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices
comment on the proposed collection of The number of commercial INDs with INDs during the annual assessment
information. No comments were activity is approximately 4,000 per year. period.
received. ERG will interview 1 to 3 sponsor FDA estimates the burden of this
representatives at a time for up to 150 collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Type of respondent responses per Total hours
respondents responses per response
respondent
IND sponsors: Surveys ................................................ 150 1 150 0.17 (10 minutes) .. 25.50
IND sponsors: Interviews ............................................ 450 1 450 1.5 .......................... 675
Total ...................................................................... ........................ ........................ ........................ ................................ 700.50
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that it will take each including each proposed extension of an third party may not wish to be posted,
IND sponsor a maximum of 10 minutes existing collection of information, and such as medical information, your or
to complete a survey. Up to 150 to allow 60 days for public comment in anyone else’s Social Security number, or
respondents will take part in the survey, response to the notice. This notice confidential business information, such
yielding a maximum burden of 25.5 solicits comments on the collection of as a manufacturing process. Please note
hours. FDA estimates that it will take information that FDA uses to establish that if you include your name, contact
each IND sponsor up to 90 minutes to and maintain lists of U.S. manufacturers information, or other information that
respond to requests for interviews and and processors with an interest in identifies you in the body of your
participate in interviews. Up to 450 exporting products regulated by the comments, that information will be
respondents will take part in interviews, Center for Food Safety and Applied posted on https://www.regulations.gov.
yielding a maximum burden of 675 Nutrition (CFSAN) to countries that • If you want to submit a comment
hours. FDA’s burden estimates are based require such lists to be maintained. The with confidential information that you
on experience with information notice also solicits comments on do not wish to be made available to the
collections for similar types of PDUFA- changes to the electronic registry that public, submit the comment as a
related assessments. will allow manufacturers and processors written/paper submission and in the
of CFSAN-regulated products to manner detailed (see ‘‘Written/Paper
Dated: November 5, 2018.
electronically request inclusion on the Submissions’’ and ‘‘Instructions’’).
Leslie Kux,
export lists. Written/Paper Submissions
Associate Commissioner for Policy.
DATES: Submit either electronic or
[FR Doc. 2018–24608 Filed 11–9–18; 8:45 am] Submit written/paper submissions as
written comments on the collection of follows:
BILLING CODE 4164–01–P
information by January 14, 2019. • Mail/Hand Delivery/Courier (for
ADDRESSES: You may submit comments written/paper submissions): Dockets
DEPARTMENT OF HEALTH AND as follows. Please note that late, Management Staff (HFA–305), Food and
HUMAN SERVICES untimely filed comments will not be Drug Administration, 5630 Fishers
considered. Electronic comments must Lane, Rm. 1061, Rockville, MD 20852.
Food and Drug Administration be submitted on or before January 14, • For written/paper comments
2019. The https://www.regulations.gov submitted to the Dockets Management
[Docket No. FDA–2018–N–4042]
electronic filing system will accept Staff, FDA will post your comment, as
Agency Information Collection comments until 11:59 p.m. Eastern Time well as any attachments, except for
Activities; Proposed Collection; at the end of January 14, 2019. information submitted, marked and
Comment Request; Establishing and Comments received by mail/hand identified, as confidential, if submitted
Maintaining Lists of U.S. delivery/courier (for written/paper as detailed in ‘‘Instructions.’’
Manufacturers/Processors With submissions) will be considered timely Instructions: All submissions received
Interest in Exporting Center for Food if they are postmarked or the delivery must include the Docket No. FDA–
Safety and Applied Nutrition-Regulated service acceptance receipt is on or 2018–N–4042 for ‘‘Agency Information
Products before that date. Collection Activities; Proposed
Collection; Comment Request;
Electronic Submissions
AGENCY: Food and Drug Administration, Establishing and Maintaining Lists of
HHS. Submit electronic comments in the Manufacturers/Processors With Interest
ACTION: Notice. following way: in Exporting CFSAN-regulated
• Federal eRulemaking Portal: Products.’’ Received comments, those
SUMMARY: The Food and Drug https://www.regulations.gov. Follow the filed in a timely manner (see
Administration (FDA or Agency) is instructions for submitting comments. ADDRESSES), will be placed in the docket
announcing an opportunity for public Comments submitted electronically, and, except for those submitted as
amozie on DSK3GDR082PROD with NOTICES1
comment on the proposed collection of including attachments, to https:// ‘‘Confidential Submissions,’’ publicly
certain information by the Agency. www.regulations.gov will be posted to viewable at https://www.regulations.gov
Under the Paperwork Reduction Act of the docket unchanged. Because your or at the Dockets Management Staff
1995 (PRA), Federal Agencies are comment will be made public, you are between 9 a.m. and 4 p.m., Monday
required to publish notice in the solely responsible for ensuring that your through Friday.
Federal Register concerning each comment does not include any • Confidential Submissions—To
proposed collection of information, confidential information that you or a submit a comment with confidential
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Document Created: 2018-11-10 03:18:00
Document Modified: 2018-11-10 03:18:00
| 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 December 13, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 56349 |
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