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, 53262-53264 [2018-22954]

Download as PDF 53262 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices restoration. In a letter dated February 8, 2018, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of TYMLOS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. daltland on DSKBBV9HB2PROD with NOTICES II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for TYMLOS is 4,130 days. Of this time, 3,735 days occurred during the testing phase of the regulatory review period, while 395 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: January 8, 2006. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was January 8, 2006. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: March 30, 2016. FDA has verified the applicant’s claim that the new drug application (NDA) for TYMLOS (NDA 208743) was initially submitted on March 30, 2016. 3. The date the application was approved: April 28, 2017. FDA has verified the applicant’s claim that NDA 208743 was approved on April 28, 2017. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 724 days, 1,123 days, or 1,128 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–22956 Filed 10–19–18; 8:45 am] BILLING CODE 4164–01–P 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. 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 oira_ submission@omb.eop.gov. 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 SUMMARY: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. 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 (§§ 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-ofphase 2 meeting’’ (§§ 312.47(b)(1)(ii) and (iv)) and a ‘‘pre-NDA meeting’’ (§ 312.47(b)(2)). While the information collection provisions of § 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/Guidance ComplianceRegulatoryInformation/ 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 E:\FR\FM\22OCN1.SGM 22OCN1 53263 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices meeting request to the appropriate FDA component as an amendment to the application for the underlying product in accordance with our regulations (§§ 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 respondents Guidance recommendations Total annual responses Average burden per response Total hours Meeting Requests: CDER ............................................................................ CBER ............................................................................ 1,319 301 2.31 1.21 3,058 363 10 10 30,580 3,630 Subtotal .................................................................. ........................ ........................ ........................ ........................ 34,210 Information Packages: CDER ............................................................................ CBER ............................................................................ 1,149 187 2.19 1.12 2,522 210 18 18 45,396 3,780 Subtotal .................................................................. ........................ ........................ ........................ ........................ 49,176 Total ................................................................ ........................ ........................ ........................ ........................ 83,386 1 There daltland on DSKBBV9HB2PROD with NOTICES Number of responses per respondent 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 VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 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 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 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 E:\FR\FM\22OCN1.SGM 22OCN1 53264 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 050’’ (Recognition List Number: 050), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective October 22, 2018. ADDRESSES: You may submit comments as follows: SUMMARY: daltland on DSKBBV9HB2PROD with NOTICES 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 VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 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– 2004–N–0451 for ‘‘Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050.’’ Received comments 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. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 050. • 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 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. An electronic copy of Recognition List Number: 050 is available on the internet at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 050 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 050’’ to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301–796–6287. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8144. FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301–796–6287, CDRHStandardsStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105–115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device E:\FR\FM\22OCN1.SGM 22OCN1

Agencies

[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53262-53264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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