Document ID: FDA-2014-N-1076-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Guidance for
Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
Posted Date: 2018-04-12T04:00Z

[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15845-15846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07543]

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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; Guidance for Industry 
on 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) 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 May 14, 
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 0910-0563. 
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, 
[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 Dispute Resolution: Scientific and 
Technical Issues Related to Pharmaceutical Current Good Manufacturing 
Practice

OMB Control Number 0910-0563--Extension

    Congress enacted section 562 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-1), which directed FDA to 
ensure that it had adequate dispute resolution procedures to provide 
for appropriate review of scientific controversies between the 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 (21 
CFR 10.75; Internal Agency review of decisions) to provide for advisory 
committee review (Sec.  10.75(b)(2)). At the same time, and also 
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, FDA developed the guidance entitled, ``Guidance for 
Industry on Formal Dispute Resolution: Scientific and Technical Issues 
Related to Pharmaceutical Current Good Manufacturing Practice.'' We 
intend the guidance to 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 for 
requesting review by the dispute resolution (DR) panel. The guidance is 
available on our website at: https://www.fda.gov/downloads/drugs/guidances/ucm070279.pdf, along with additional information regarding 
the resolution of scientific disputes at FDA.
    In the Federal Register of October 27, 2017 (82 FR 49832), we 
published a notice soliciting public comment on the proposed collection 
of information. Although no comments were received, we are 
reconsidering the usefulness of the guidance document in light of 
changing Agency procedures. Consistent with our regulations at 21 CFR 
part 10.115 we invite comment on our guidance documents at any time. 
Ultimately, as our resources permit, we hope to either revise, replace, 
or withdraw the subject guidance document, however, until that time the 
guidance remains available. Accordingly, we are seeking to extend OMB 
approval of the information collection and estimate the burden as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual                          Average
            Activity                 Number of    frequency  per   Total  annual    burden per      Total hours
                                    respondents      response        responses       response
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Requests for tier-one DR                       2               1               2              30              60
Requests for tier-two DR                       1               1               1               8               8
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    Total.......................  ..............  ..............  ..............  ..............              68
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    As reflected in table 1, we estimate only a nominal burden for the 
information collection and assume: (1) That two manufacturers will 
submit two requests annually for tier-one DR; (2) that there will be 
one appeal to the DR panel (tier-two DR); (3) that it will take 
respondents approximately 30 hours to prepare and submit each tier-one 
DR request; and (4) that it will take approximately 8 hours to prepare 
and submit each tier-two DR request. We base this estimate on our 
experience with the information collection. There has been no increase 
in the burden

[[Page 15846]]

estimate since the previous OMB approval.

    Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07543 Filed 4-11-18; 8:45 am]
 BILLING CODE 4164-01-P