83_FR_5811 83 FR 5783 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine

83 FR 5783 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 28 (February 9, 2018)

Page Range5783-5784
FR Document2018-02593

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.

Federal Register, Volume 83 Issue 28 (Friday, February 9, 2018) 
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5783-5784]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6145]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Dispute Resolution 
Procedures for Science-Based Decisions on Products Regulated by the 
Center for Veterinary Medicine

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 
12, 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 0910-0566. 
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.

Dispute Resolution Procedures for Science-Based Decisions on Products 
Regulated by the Center for Veterinary Medicine--21 CFR 10.75

OMB Control Number 0910-0566--Extension

    The Center for Veterinary Medicine's (CVM's) Guidance for Industry 
(GIF) #79, ``Dispute Resolution Procedures for Science-Based Decisions 
on Products Regulated by the Center for Veterinary Medicine'' (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052393.pdf), describes the process by which CVM 
formally resolves disputes relating to scientific controversies. A 
scientific controversy involves issues concerning a specific product 
regulated by CVM related to matters of technical expertise and requires 
specialized education, training, or experience to be understood and 
resolved. The guidance details information on how CVM intends to apply 
provisions of existing regulations regarding internal review of Agency 
decisions. In addition, the guidance outlines the established 
procedures for persons who are sponsors, applicants, or manufacturers 
of animal drugs or other products regulated by CVM that wish to submit 
a request for review of a scientific dispute. When a sponsor, 
applicant, or manufacturer has a scientific disagreement with a written 
decision by CVM, they may submit a request for a review of that 
decision by following the established procedures discussed in the 
guidance.
    CVM encourages applicants to begin the resolution of science-based 
disputes with discussions with the review team/group, including the 
Team Leader or Division Director. The Center prefers that differences 
of opinion regarding science or science-based policy be resolved 
between the review team/group and the applicant. If the matter is not 
resolved by this preferred method then CVM recommends that the 
applicant follow the procedures in GFI #79.
    In the Federal Register of October 27, 2017 (82 FR 49836), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received no comments.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 5784]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75, Request for review of a scientific dispute..................               1                4                4               10               40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the next 3 years, CVM anticipates receiving one or fewer 
requests for review of a scientific dispute per year, on average. We 
base our estimate on CVM's experience over the past 6 years in handling 
formal appeals for scientific disputes. The burden of this collection 
has changed. The number of respondents decreased from two to one 
annually, the number of responses per respondent remained at four 
annually, the hours per response remained at 10 annually, and the total 
number of hours decreased from 80 to 40. This decrease in the total 
hours is the result of a natural fluctuation in the number of 
respondents taking advantage of this dispute resolution process.

    Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02593 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5783 2006, which was 30 days after FDA Dated: February 5, 2018. Dispute Resolution Procedures for receipt of an earlier IND. Leslie Kux, Science-Based Decisions on Products 2. The date the application was Associate Commissioner for Policy. Regulated by the Center for Veterinary initially submitted with respect to the [FR Doc. 2018–02592 Filed 2–8–18; 8:45 am] Medicine—21 CFR 10.75 human drug product under section BILLING CODE 4164–01–P OMB Control Number 0910–0566— 505(b) of the FD&C Act: December 17, Extension 2014. FDA has verified the applicant’s claim that the new drug application DEPARTMENT OF HEALTH AND The Center for Veterinary Medicine’s (NDA) for ENTRESTO (NDA 207620) HUMAN SERVICES (CVM’s) Guidance for Industry (GIF) was initially submitted on December 17, #79, ‘‘Dispute Resolution Procedures for 2014. Food and Drug Administration Science-Based Decisions on Products [Docket No. FDA–2017–N–6145] Regulated by the Center for Veterinary 3. The date the application was Medicine’’ (https://www.fda.gov/ approved: July 7, 2015. FDA has verified Agency Information Collection downloads/AnimalVeterinary/Guidance the applicant’s claim that NDA 207620 Activities; Submission for Office of ComplianceEnforcement/Guidancefor was approved on July 7, 2015. Management and Budget Review; Industry/UCM052393.pdf), describes the This determination of the regulatory Comment Request; Dispute Resolution process by which CVM formally review period establishes the maximum Procedures for Science-Based resolves disputes relating to scientific potential length of a patent extension. Decisions on Products Regulated by controversies. A scientific controversy However, the USPTO applies several the Center for Veterinary Medicine involves issues concerning a specific statutory limitations in its calculations product regulated by CVM related to of the actual period for patent extension. AGENCY: Food and Drug Administration, matters of technical expertise and In its applications for patent extension, HHS. requires specialized education, training, this applicant seeks 1,296 days, 732 ACTION: Notice. or experience to be understood and days, 519 days, 270 days or 225 days of resolved. The guidance details patent term extension. SUMMARY: The Food and Drug Administration (FDA) is announcing information on how CVM intends to III. Petitions that a proposed collection of apply provisions of existing regulations information has been submitted to the regarding internal review of Agency Anyone with knowledge that any of Office of Management and Budget decisions. In addition, the guidance the dates as published are incorrect may (OMB) for review and clearance under outlines the established procedures for submit either electronic or written the Paperwork Reduction Act of 1995. persons who are sponsors, applicants, or comments and, under 21 CFR 60.24, ask manufacturers of animal drugs or other DATES: Fax written comments on the for a redetermination (see DATES). products regulated by CVM that wish to collection of information by March 12, Furthermore, as specified in § 60.30 (21 submit a request for review of a 2018. CFR 60.30), any interested person may scientific dispute. When a sponsor, petition FDA for a determination ADDRESSES: To ensure that comments on applicant, or manufacturer has a regarding whether the applicant for the information collection are received, scientific disagreement with a written extension acted with due diligence OMB recommends that written decision by CVM, they may submit a during the regulatory review period. To comments be faxed to the Office of Information and Regulatory Affairs, request for a review of that decision by meet its burden, the petition must following the established procedures comply with all the requirements of OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ discussed in the guidance. § 60.30, including but not limited to: CVM encourages applicants to begin Must be timely (see DATES), must be submission@omb.eop.gov. All comments should be identified with the the resolution of science-based disputes filed in accordance with § 10.20, must with discussions with the review team/ contain sufficient facts to merit an FDA OMB control number 0910–0566. Also include the FDA docket number found group, including the Team Leader or investigation, and must certify that a Division Director. The Center prefers true and complete copy of the petition in brackets in the heading of this document. that differences of opinion regarding has been served upon the patent science or science-based policy be applicant. (See H. Rept. 857, part 1, 98th FOR FURTHER INFORMATION CONTACT: Ila resolved between the review team/group Cong., 2d sess., pp. 41–42, 1984.) S. Mizrachi, Office of Operations, Food and the applicant. If the matter is not Petitions should be in the format and Drug Administration, Three White resolved by this preferred method then specified in 21 CFR 10.30. Flint North, 10A–12M, 11601 CVM recommends that the applicant Submit petitions electronically to Landsdown St., North Bethesda, MD follow the procedures in GFI #79. https://www.regulations.gov at Docket 20852, 301–796–7726, PRAStaff@ In the Federal Register of October 27, No. FDA–2013–S–0610. Submit written fda.hhs.gov. 2017 (82 FR 49836), FDA published a petitions (two copies are required) to the SUPPLEMENTARY INFORMATION: In 60-day notice requesting public Dockets Management Staff (HFA–305), compliance with 44 U.S.C. 3507, FDA comment on the proposed collection of Food and Drug Administration, 5630 has submitted the following proposed information. We received no comments. Fishers Lane, Rm. 1061, Rockville, MD collection of information to OMB for FDA estimates the burden of this 20852. review and clearance. collection of information as follows: sradovich on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1

5784 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Total Average Number of Total 21 CFR section responses per annual burden per respondents hours respondent responses response 10.75, Request for review of a scientific dispute ................ 1 4 4 10 40 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In the next 3 years, CVM anticipates DATES: Fax written comments on the to require that persons subject to receiving one or fewer requests for collection of information by March 12, mandatory reporting requirements review of a scientific dispute per year, 2018. submit safety reports in an electronic on average. We base our estimate on ADDRESSES: To ensure that comments on format that FDA can process, review, CVM’s experience over the past 6 years the information collection are received, and archive. Specifically, this includes: in handling formal appeals for scientific OMB recommends that written • Manufacturers; packers; disputes. The burden of this collection comments be faxed to the Office of distributors; applicants with approved has changed. The number of Information and Regulatory Affairs, new drug applications, abbreviated new respondents decreased from two to one OMB, Attn: FDA Desk Officer, Fax: 202– drug applications, and biologics annually, the number of responses per 395–7285, or emailed to oira_ licensing applications (BLAs); and those respondent remained at four annually, submission@omb.eop.gov. All that market prescription drugs for the hours per response remained at 10 comments should be identified with the human use without an approved annually, and the total number of hours OMB control number 0910–0770. Also application must submit postmarketing decreased from 80 to 40. This decrease include the FDA docket number found safety reports to the Agency (§§ 310.305, in the total hours is the result of a in brackets in the heading of this 314.80, 314.98, and 600.80); natural fluctuation in the number of document. • manufacturers, packers, or respondents taking advantage of this distributors whose name appears on the dispute resolution process. FOR FURTHER INFORMATION CONTACT: label of nonprescription human drug Domini Bean, Office of Operations, Dated: February 5, 2018. products marketed without an approved Food and Drug Administration, Three Leslie Kux, application must report serious adverse White Flint North, 10A–12M, 11601 Associate Commissioner for Policy. events associated with their products Landsdown St., North Bethesda, MD [FR Doc. 2018–02593 Filed 2–8–18; 8:45 am] (section 760 of the Federal Food, Drug, 20852, 301–796–5733, PRAStaff@ and Cosmetic Act (FD&C Act) (21 U.S.C. BILLING CODE 4164–01–P fda.hhs.gov. 379aa)); and SUPPLEMENTARY INFORMATION: In • applicants with approved BLAs DEPARTMENT OF HEALTH AND compliance with 44 U.S.C. 3507, FDA must submit biological lot distribution HUMAN SERVICES has submitted the following proposed reports to the Agency (§ 600.81). collection of information to OMB for Under §§ 310.305(e)(2), 314.80(g)(2), Food and Drug Administration review and clearance. 329.100(c)(2), 600.80(h)(2), and [Docket No. FDA–2008–N–0334] Postmarketing Safety Reports for 600.81(b)(2), of the regulations, those Human Drug and Biological Products: who are subject to these postmarketing Agency Information Collection Waivers From Electronic Submission safety reporting requirements may Activities; Submission for Office of Requirements request a waiver from the electronic Management and Budget Review; format requirement. While FDA Comment Request; Postmarketing OMB Control Number 0910–0770— currently has OMB approval for the Safety Reports for Human Drug and Extension collection of postmarketing safety Biological Products: Electronic This information collection supports reports,1 this information collection Submission Requirements information collection found in FDA supports respondents seeking waivers AGENCY: Food and Drug Administration, regulations. In the Federal Register of from submitting those reports in HHS. June 10, 2014 (79 FR 33072), FDA electronic format as required by the published a final rule entitled regulations. ACTION: Notice. ‘‘Postmarketing Safety Reports for In the Federal Register of October 30, SUMMARY: The Food and Drug Human Drug and Biological Products: 2017 (82 FR 50141), we published a 60- Administration (FDA) is announcing Electronic Submission Requirements.’’ day notice requesting public comment that a proposed collection of The final rule amended FDA’s on the proposed extension of this information has been submitted to the postmarketing safety reporting collection of information. No comments Office of Management and Budget regulations for human drug and were received in response to the notice. (OMB) for review and clearance under biological products under 21 CFR parts We therefore estimate the burden of the Paperwork Reduction Act of 1995. 310, 314, and 600 and added part 329 this collection of information as follows: sradovich on DSK3GMQ082PROD with NOTICES 1 FDA currently has OMB approval for Control Numbers 0910–0291 and 0910–0230. The FD&C Act have been approved under OMB Control submission of postmarketing safety reports under information collection for part 600 is approved Number 0910–0636. parts 310, 314, and 600. The information collection under OMB Control Numbers 0910–0291 and 0910– for parts 310 and 314 is approved under OMB 0308. Submissions required by section 760 of the VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1


Document Created: 2018-02-09 00:12:00
Document Modified: 2018-02-09 00:12:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by March 12, 2018.
ContactIla 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 Citation83 FR 5783 
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