83 FR 53262 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 204 (October 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 204 (October 22, 2018)
| Page Range | 53262-53264 | |
| FR Document | 2018-22954 |
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)] [Notices] [Pages 53262-53264] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22954] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2434] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 November 21, 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 0910-0429. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [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 on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products OMB Control Number 0910-0429--Extension This information collection supports the above captioned Agency guidance document. The guidance document was issued to help individuals with procedures on formal meetings between FDA and sponsors or applicants regarding the development and review of Prescription Drug User Fee Act (PDUFA) products. The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. The guidance provides information on how FDA interprets and applies section 119(a) of the Food and Drug Administration Modernization Act of 2007 (Pub. L. 105-115), specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (Sec. Sec. 12.47 and 312.82 (21 CFR 312.47 and 312.82)). The collection of information described in the guidance reflects the current and past practice of sponsors and applicants to submit meeting requests and background information prior to a scheduled meeting. Agency regulations currently permit such requests and recommend the submission of an information package before an ``end-of- phase 2 meeting'' (Sec. Sec. [thinsp]312.47(b)(1)(ii) and (iv)) and a ``pre-NDA meeting'' (Sec. [thinsp]312.47(b)(2)). While the information collection provisions of Sec. [thinsp]312.47 are currently approved under OMB control number 0910-0014, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. The guidance document is available on our website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf. Request for a Meeting--Consistent with recommendations found in the guidance, a sponsor or applicant interested in meeting with the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) should submit a [[Page 53263]] meeting request to the appropriate FDA component as an amendment to the application for the underlying product in accordance with our regulations (Sec. Sec. [thinsp]312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)). Information provided to the Agency as part of an investigational new drug application (IND), new drug application (NDA), or biological license application (BLA) must be submitted with an appropriate cover form. Form FDA 1571 must accompany IND submissions, and Form FDA 356h must accompany NDA and BLA submissions. These Agency forms are approved under OMB control numbers 0910-0014 and 0910-0338, respectively. We recommend that a request be submitted in this manner to ensure that each request is kept in the administrative file with the complete application, and to ensure that pertinent information about the request is entered into appropriate tracking databases. Using information from our tracking databases enables us to monitor progress on activities attendant to scheduling and holding a formal meeting and to ensure that appropriate steps will be taken in a timely manner. The guidance recommends that meeting requests include the following information:Information identifying and describing the product the type of meeting being requested a brief statement of the purpose of the meeting a list of objectives and expected outcomes from the meeting a preliminary proposed agenda a draft list of questions to be raised at the meeting a list of individuals who will represent the sponsor or applicant at the meeting a list of Agency staff requested to be in attendance the approximate date that the information package will be sent to the Agency suggested dates and times for the meeting We use the information to determine the purpose of the meeting, the necessary participants, the proposed agenda, and to schedule the meeting. Information Package--The guidance also recommends that a sponsor or applicant submitting an information package provide summary information relevant to the product and supplementary information pertaining to any issue raised by the sponsor, applicant, or FDA. Information packages should generally include: Identifying information about the underlying product a brief statement of the purpose of the meeting a list of objectives and expected outcomes of the meeting a proposed agenda for the meeting a list of specific questions to be addressed at the meeting a summary of clinical data that will be discussed (as appropriate) a summary of preclinical data that will be discussed (as appropriate) chemistry, manufacturing, and controls information that may be discussed (as appropriate) The information package enables Agency staff to prepare for the meeting and allows appropriate time for reviewing relevant product data. Although FDA reviews similar information in the meeting request, the information package should provide updated data reflecting the most current and accurate information available to the sponsor or applicant. In the Federal Register of July 11, 2018 (83 FR 32130), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Guidance recommendations Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Meeting Requests: CDER........................ 1,319 2.31 3,058 10 30,580 CBER........................ 301 1.21 363 10 3,630 rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Subtotal................ .............. .............. .............. .............. 34,210 rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Information Packages: CDER........................ 1,149 2.19 2,522 18 45,396 CBER........................ 187 1.12 210 18 3,780 rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Subtotal................ .............. .............. .............. .............. 49,176 rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Total............... .............. .............. .............. .............. 83,386 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects an overall increase since the previous OMB approval. We attribute this adjustment to an increase in the number of meeting requests and information packages received over the last few years. Based on Agency data, we estimate 1,319 sponsors and applicants (respondents) request 3,058 formal meetings with CDER annually, and 301 respondents request 363 formal meetings with CBER annually regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent spends preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be 10 hours. We expect it takes this amount of time to gather and copy brief statements about the product as well as a description of the purpose and details of the meeting. Also consistent with Agency data, we estimate 1,149 respondents submitted 2,522 information packages to CDER annually, and 187 respondents submitted 210 information packages to CBER annually, prior to a formal meeting regarding the development and review of a PDUFA product. We estimate 18 hours is needed to prepare [[Page 53264]] the information package in accordance with the guidance. Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22954 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
![53262 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
restoration. In a letter dated February 8, investigation, and must certify that a North, 10A–12M, 11601 Landsdown St.,
2018, FDA advised the USPTO that this true and complete copy of the petition North Bethesda, MD 20852, 301–796–
human drug product had undergone a has been served upon the patent 3794, PRAStaff@fda.hhs.gov.
regulatory review period and that the applicant. (See H. Rept. 857, part 1, 98th SUPPLEMENTARY INFORMATION: In
approval of TYMLOS represented the Cong., 2d sess., pp. 41–42, 1984.) compliance with 44 U.S.C. 3507, FDA
first permitted commercial marketing or Petitions should be in the format has submitted the following proposed
use of the product. Thereafter, the specified in 21 CFR 10.30. collection of information to OMB for
USPTO requested that FDA determine Submit petitions electronically to review and clearance.
the product’s regulatory review period. https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written Guidance for Industry on Formal
II. Determination of Regulatory Review Meetings With Sponsors and
petitions (two copies are required) to the
Period Applicants for Prescription Drug User
Dockets Management Staff (HFA–305),
FDA has determined that the Food and Drug Administration, 5630 Fee Act Products
applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD OMB Control Number 0910–0429—
TYMLOS is 4,130 days. Of this time, 20852. Extension
3,735 days occurred during the testing
Dated: October 16, 2018. This information collection supports
phase of the regulatory review period,
while 395 days occurred during the Leslie Kux, the above captioned Agency guidance
approval phase. These periods of time Associate Commissioner for Policy. document. The guidance document was
were derived from the following dates: [FR Doc. 2018–22956 Filed 10–19–18; 8:45 am] issued to help individuals with
1. The date an exemption under BILLING CODE 4164–01–P procedures on formal meetings between
section 505(i) of the Federal Food, Drug, FDA and sponsors or applicants
and Cosmetic Act (FD&C Act) (21 U.S.C. regarding the development and review
355(i)) became effective: January 8, DEPARTMENT OF HEALTH AND of Prescription Drug User Fee Act
2006. FDA has verified the applicant’s HUMAN SERVICES (PDUFA) products. The guidance
claim that the date the investigational describes procedures for requesting,
Food and Drug Administration scheduling, conducting, and
new drug application became effective
was January 8, 2006. [Docket No. FDA–2018–N–2434] documenting such formal meetings. The
2. The date the application was guidance provides information on how
initially submitted with respect to the Agency Information Collection FDA interprets and applies section
human drug product under section Activities; Submission for Office of 119(a) of the Food and Drug
505(b) of the FD&C Act: March 30, 2016. Management and Budget Review; Administration Modernization Act of
FDA has verified the applicant’s claim Comment Request; Guidance for 2007 (Pub. L. 105–115), specific PDUFA
that the new drug application (NDA) for Industry on Formal Meetings With goals for the management of meetings
TYMLOS (NDA 208743) was initially Sponsors and Applicants for associated with the review of human
submitted on March 30, 2016. Prescription Drug User Fee Act drug applications for PDUFA products,
3. The date the application was Products and provisions of existing regulations
approved: April 28, 2017. FDA has describing certain meetings (§§ 12.47
AGENCY: Food and Drug Administration, and 312.82 (21 CFR 312.47 and 312.82)).
verified the applicant’s claim that NDA HHS.
208743 was approved on April 28, 2017. The collection of information described
This determination of the regulatory ACTION: Notice. in the guidance reflects the current and
review period establishes the maximum SUMMARY: The Food and Drug past practice of sponsors and applicants
potential length of a patent extension. Administration (FDA, Agency, or we) is to submit meeting requests and
However, the USPTO applies several announcing that a proposed collection background information prior to a
statutory limitations in its calculations of information has been submitted to the scheduled meeting. Agency regulations
of the actual period for patent extension. Office of Management and Budget currently permit such requests and
In its applications for patent extension, (OMB) for review and clearance under recommend the submission of an
this applicant seeks 724 days, 1,123 the Paperwork Reduction Act of 1995. information package before an ‘‘end-of-
days, or 1,128 days of patent term phase 2 meeting’’ (§§ 312.47(b)(1)(ii)
DATES: Fax written comments on the
extension. and (iv)) and a ‘‘pre-NDA meeting’’
collection of information by November
(§ 312.47(b)(2)). While the information
III. Petitions 21, 2018.
collection provisions of § 312.47 are
Anyone with knowledge that any of ADDRESSES: To ensure that comments on
currently approved under OMB control
the dates as published are incorrect may the information collection are received, number 0910–0014, the guidance
submit either electronic or written OMB recommends that written provides additional recommendations
comments and, under 21 CFR 60.24, ask comments be faxed to the Office of for submitting information to FDA in
for a redetermination (see DATES). Information and Regulatory Affairs, support of a meeting request. The
Furthermore, as specified in § 60.30 (21 OMB, Attn: FDA Desk Officer, Fax: 202– guidance document is available on our
CFR 60.30), any interested person may 395–7285, or emailed to oira_ website at: https://www.fda.gov/
petition FDA for a determination submission@omb.eop.gov. All downloads/Drugs/Guidance
regarding whether the applicant for comments should be identified with the ComplianceRegulatoryInformation/
extension acted with due diligence OMB control number 0910–0429. Also Guidances/UCM590547.pdf.
daltland on DSKBBV9HB2PROD with NOTICES
during the regulatory review period. To include the FDA docket number found Request for a Meeting—Consistent
meet its burden, the petition must in brackets in the heading of this with recommendations found in the
comply with all the requirements of document. guidance, a sponsor or applicant
§ 60.30, including but not limited to: FOR FURTHER INFORMATION CONTACT: interested in meeting with the Center for
Must be timely (see DATES), must be JonnaLynn Capezzuto, Office of Drug Evaluation and Research (CDER) or
filed in accordance with § 10.20, must Operations, Food and Drug the Center for Biologics Evaluation and
contain sufficient facts to merit an FDA Administration, Three White Flint Research (CBER) should submit a
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![53264 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
the information package in accordance information, or other information that information on the cover sheet and not
with the guidance. identifies you in the body of your in the body of your comments and you
Dated: October 16, 2018. comments, that information will be must identify this information as
Leslie Kux,
posted on https://www.regulations.gov. ‘‘confidential.’’ Any information marked
• If you want to submit a comment as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. with confidential information that you except in accordance with 21 CFR 10.20
[FR Doc. 2018–22954 Filed 10–19–18; 8:45 am] do not wish to be made available to the and other applicable disclosure law. For
BILLING CODE 4164–01–P public, submit the comment as a more information about FDA’s posting
written/paper submission and in the of comments to public dockets, see 80
manner detailed (see ‘‘Written/Paper FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). the information at: http://www.gpo.gov/
HUMAN SERVICES
Written/Paper Submissions fdsys/pkg/FR-2015-09-18/pdf/2015-
Food and Drug Administration 23389.pdf.
Submit written/paper submissions as
follows: Docket: For access to the docket to
[Docket No. FDA–2004–N–0451]
• Mail/Hand delivery/Courier (for read background documents or the
Food and Drug Administration written/paper submissions): Dockets electronic and written/paper comments
Modernization Act of 1997: Management Staff (HFA–305), Food and received, go to https://
Modifications to the List of Recognized Drug Administration, 5630 Fishers www.regulations.gov and insert the
Standards, Recognition List Number: Lane, Rm. 1061, Rockville, MD 20852. docket number, found in brackets in the
050 • For written/paper comments heading of this document, into the
submitted to the Dockets Management ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as and/or go to the Dockets Management
HHS. well as any attachments, except for Staff, 5630 Fishers Lane, Rm. 1061,
ACTION: Notice. information submitted, marked and Rockville, MD 20852.
identified, as confidential, if submitted An electronic copy of Recognition List
SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’ Number: 050 is available on the internet
Administration (FDA or Agency) is Instructions: All submissions received at https://www.fda.gov/MedicalDevices/
announcing a publication containing must include the Docket No. FDA– DeviceRegulationandGuidance/
modifications the Agency is making to 2004–N–0451 for ‘‘Food and Drug Standards/ucm123792.htm. See section
the list of standards FDA recognizes for Administration Modernization Act of IV for electronic access to the searchable
use in premarket reviews (FDA 1997: Modifications to the List of database for the current list of FDA
Recognized Consensus Standards). This Recognized Standards, Recognition List recognized consensus standards,
publication, entitled ‘‘Modifications to Number: 050.’’ Received comments will including Recognition List Number: 050
the List of Recognized Standards, be placed in the docket and, except for modifications and other standards
Recognition List Number: 050’’ those submitted as ‘‘Confidential related information. Submit written
(Recognition List Number: 050), will Submissions,’’ publicly viewable at requests for a single hard copy of the
assist manufacturers who elect to https://www.regulations.gov or at the document entitled ‘‘Modifications to the
declare conformity with consensus Dockets Management Staff between 9 List of Recognized Standards,
standards to meet certain requirements a.m. and 4 p.m., Monday through Recognition List Number: 050’’ to Scott
for medical devices. Friday. FDA will consider any Colburn, Center for Devices and
DATES: Submit electronic or written comments received in determining Radiological Health, Food and Drug
comments concerning this document at whether to amend the current listing of Administration, 10903 New Hampshire
any time. These modifications to the list modifications to the list of recognized Ave., Bldg. 66, Rm. 5514, Silver Spring,
of recognized standards are effective standards, Recognition List Number: MD 20993, 301–796–6287. Send one
October 22, 2018. 050. self-addressed adhesive label to assist
ADDRESSES: You may submit comments • Confidential Submissions—To that office in processing your request, or
as follows: submit a comment with confidential fax your request to 301–847–8144.
information that you do not wish to be
Electronic Submissions FOR FURTHER INFORMATION CONTACT:
made publicly available, submit your
Scott Colburn, Center for Devices and
Submit electronic comments in the comments only as a written/paper
Radiological Health, Food and Drug
following way: submission. You should submit two
Administration, 10903 New Hampshire
• Federal eRulemaking Portal: copies total. One copy will include the
Ave., Bldg. 66, Rm. 5514, Silver Spring,
https://www.regulations.gov. Follow the information you claim to be confidential
MD 20993, 301–796–6287,
instructions for submitting comments. with a heading or cover note that states
CDRHStandardsStaff@fda.hhs.gov.
Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS
including attachments, to https:// CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION:
www.regulations.gov will be posted to Agency will review this copy, including I. Background
the docket unchanged. Because your the claimed confidential information, in
comment will be made public, you are its consideration of comments. The Section 204 of the Food and Drug
solely responsible for ensuring that your second copy, which will have the Administration Modernization Act of
comment does not include any claimed confidential information 1997 (FDAMA) (Pub. L. 105–115)
daltland on DSKBBV9HB2PROD with NOTICES
confidential information that you or a redacted/blacked out, will be available amended section 514 of the Federal
third party may not wish to be posted, for public viewing and posted on Food, Drug, and Cosmetic Act (the
such as medical information, your or https://www.regulations.gov. Submit FD&C Act) (21 U.S.C. 360d). Amended
anyone else’s Social Security number, or both copies to the Dockets Management section 514 allows FDA to recognize
confidential business information, such Staff. If you do not wish your name and consensus standards developed by
as a manufacturing process. Please note contact information to be made publicly international and national organizations
that if you include your name, contact available, you can provide this for use in satisfying portions of device
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Document Created: 2018-10-20 01:49:36
Document Modified: 2018-10-20 01:49:36
| 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 November 21, 2018. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected] | |
| FR Citation | 83 FR 53262 |
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