[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Pages 19270-19271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07549]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1076]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Formal Dispute 
Resolution: Scientific and Technical Issues Related to Pharmaceutical 
Current Good Manufacturing Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA 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: Submit written comments (including recommendations) on the 
collection of information by May 13, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0563. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
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.

Formal Dispute Resolution: Scientific and Technical Issues Related to 
Pharmaceutical Current Good Manufacturing Practice

OMB Control Number 0910-0563--Extension

    Section 562 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 360bbb-1) directs FDA to establish adequate dispute 
resolution (DR) procedures to ensure appropriate review of scientific 
controversies between FDA and members of regulated industry, including 
possible review by a scientific advisory committee. To implement this 
provision, we amended the general appeal regulation applicable across 
all FDA components (Sec.  10.75 (21 CFR 10.75)) to provide for advisory 
committee review (Sec.  10.75(b)(2)). At the same time and consistent 
with the mandates of section 562 of the FD&C Act, we adopted an 
approach whereby specific implementation procedures regarding 
scientific controversy associated with review of certain FDA decisions 
are detailed in center-issued guidance.
    Accordingly, we developed the guidance for industry ``Formal 
Dispute Resolution: Scientific and Technical Issues Related to 
Pharmaceutical Current Good Manufacturing Practice.'' We intend that 
the guidance inform manufacturers of veterinary and human drugs, 
including human biological drug products, on how to resolve disputes 
about scientific and technical issues relating to current good 
manufacturing practice (CGMP).
    Disputes related to scientific and technical issues may arise 
during FDA inspections of pharmaceutical manufacturers to determine 
compliance with CGMP requirements or during FDA's assessment of 
corrective actions undertaken as a result of such inspections. The 
guidance recommends procedures that we believe encourage open and 
prompt discussion of disputes and lead to their resolution. The 
guidance describes procedures for raising such disputes to the Office 
of Regulatory Affairs, and Center levels and procedures for requesting 
review by the DR panel. The guidance is available on our website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, along with additional information regarding the resolution 
of scientific disputes at FDA.
    We estimate only a nominal burden for the information collection 
and assume that one manufacturer will submit one request annually for 
tier-one DR and that it will take manufacturers approximately 30 hours 
to prepare and submit each tier-one DR request. Since our last request 
for OMB approval of the information collection, we have received no 
tier-two DRs.
    In the Federal Register of December 9, 2020 (85 FR 79186), 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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Requests for tier-one DR...........................................               1                1                1               30               30
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


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    Our estimated burden for the information collection reflects a 
decrease of 38 hours and a decrease of 1 request. This adjustment 
corresponds to a decrease in the number of submissions we have received 
over the last few years.

    Dated: April 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07549 Filed 4-12-21; 8:45 am]
BILLING CODE 4164-01-P


