Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug User Fee Cover Sheet; Form FDA 3397, 2235-2236 [2019-01249]

Download as PDF Federal Register / Vol. 84, No. 25 / Wednesday, February 6, 2019 / Notices amozie on DSK3GDR082PROD with NOTICES1 appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before February 11, 2019, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 7, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 8, 2019. Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Kalyani Bhatt (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 1, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–01232 Filed 2–5–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:09 Feb 05, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–N–0101] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug User Fee Cover Sheet; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 March 8, 2019. 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 0910–0297. 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, 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. SUMMARY: Prescription Drug User Fee Cover Sheet; Form FDA 3397 OMB Control Number 0910–0297— Extension Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and collect user fees for certain drug and biologics license applications (BLAs). Under this authority, PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 2235 pharmaceutical companies pay a fee for certain new human drug applications (NDAs) and BLAs submitted to the Agency for review. Because the submission of prescription drug user fees concurrently with applications is required, review of an application by FDA cannot begin until the fee is submitted. The Prescription Drug User Fee Cover Sheet, Form FDA 3397, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. The form provides a cross-reference of the fee submitted for an application by using a unique number tracking system. The information collected is used by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of NDAs and BLAs. Respondents to this collection of information are drug and biologics manufacturers that submit NDAs and BLAs. Based on FDA’s database system for fiscal year (FY) 2017, there are an estimated 155 manufacturers of products subject to the Prescription Drug User Fee Act (Pub. L. 105–115), as amended by the FDA Reauthorization Act of 2017 (Pub. L. 115–52.) The total number of annual responses is based on the number of application submissions received by FDA in FY 2017. CDER received 250 annual responses that included the following submissions: 218 NDAs and 32 BLAs. CBER received 12 BLAs. The estimated hours per response are based on past FDA experience with the various submissions. In the Federal Register of August 24, 2018 (83 FR 42900), we published a 60day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: E:\FR\FM\06FEN1.SGM 06FEN1 2236 Federal Register / Vol. 84, No. 25 / Wednesday, February 6, 2019 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FDA form Number of respondents 3397 .............................. 1 There Number of responses per respondent 155 1.6903 Dated: February 1, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–01249 Filed 2–5–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–0078] Principles of Premarket Pathways for Combination Products; Draft Guidance for Industry; Availability Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Principles of Premarket Pathways for Combination Products.’’ This draft guidance presents FDA’s current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. FDA is publishing this draft guidance as part of its efforts to implement the 21st Century Cures Act (Cures Act) and in keeping with the Agency’s longstanding commitment to transparency, efficiency, and regulatory consistency to facilitate development of safe and effective combination products. SUMMARY: amozie on DSK3GDR082PROD with NOTICES1 262 0.5 (30 minutes) ................................................... Total hours 131 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 decrease of 1,724 hours and a corresponding decrease of 3,448 responses. We attribute this program change to the restructuring of the Prescription Drug Use Fee Program fees. The FD&C Act, as amended by the Prescription Drug User Fee Amendments of 2017, authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and discontinued the supplement fee. This resulted in the removal of supplements from the Prescription Drug User Fee Cover Sheet, therefore reducing the burden for this collection of information. AGENCY: Average burden per response Total annual responses VerDate Sep<11>2014 18:09 Feb 05, 2019 Jkt 247001 Submit either electronic or written comments on the draft guidance by May 7, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–0078 for ‘‘Principles of PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 Premarket Pathways for Combination Products.’’ 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. • 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 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). E:\FR\FM\06FEN1.SGM 06FEN1

Agencies

[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Pages 2235-2236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0101]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prescription Drug 
User Fee Cover Sheet; Form FDA 3397

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 March 
8, 2019.

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 0910-0297. 
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, 
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.

Prescription Drug User Fee Cover Sheet; Form FDA 3397

OMB Control Number 0910-0297--Extension

    Under the prescription drug user fee provisions of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (sections 735 and 736 (21 
U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and 
collect user fees for certain drug and biologics license applications 
(BLAs). Under this authority, pharmaceutical companies pay a fee for 
certain new human drug applications (NDAs) and BLAs submitted to the 
Agency for review. Because the submission of prescription drug user 
fees concurrently with applications is required, review of an 
application by FDA cannot begin until the fee is submitted. The 
Prescription Drug User Fee Cover Sheet, Form FDA 3397, is designed to 
provide the minimum necessary information to determine whether a fee is 
required for review of an application, to determine the amount of the 
fee required, and to account for and track user fees. The form provides 
a cross-reference of the fee submitted for an application by using a 
unique number tracking system. The information collected is used by 
FDA's Center for Drug Evaluation and Research (CDER) and Center for 
Biologics Evaluation and Research (CBER) to initiate the administrative 
screening of NDAs and BLAs.
    Respondents to this collection of information are drug and 
biologics manufacturers that submit NDAs and BLAs. Based on FDA's 
database system for fiscal year (FY) 2017, there are an estimated 155 
manufacturers of products subject to the Prescription Drug User Fee Act 
(Pub. L. 105-115), as amended by the FDA Reauthorization Act of 2017 
(Pub. L. 115-52.)
    The total number of annual responses is based on the number of 
application submissions received by FDA in FY 2017. CDER received 250 
annual responses that included the following submissions: 218 NDAs and 
32 BLAs. CBER received 12 BLAs. The estimated hours per response are 
based on past FDA experience with the various submissions.
    In the Federal Register of August 24, 2018 (83 FR 42900), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

[[Page 2236]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           FDA form                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
3397..........................             155          1.6903             262  0.5 (30 minutes)             131
----------------------------------------------------------------------------------------------------------------
\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 decrease of 1,724 hours and a corresponding decrease of 3,448 
responses. We attribute this program change to the restructuring of the 
Prescription Drug Use Fee Program fees. The FD&C Act, as amended by the 
Prescription Drug User Fee Amendments of 2017, authorizes FDA to 
collect application fees for certain applications for the review of 
human drug and biological products and discontinued the supplement fee. 
This resulted in the removal of supplements from the Prescription Drug 
User Fee Cover Sheet, therefore reducing the burden for this collection 
of information.

    Dated: February 1, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01249 Filed 2-5-19; 8:45 am]
 BILLING CODE 4164-01-P