83 FR 15845 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 71 (April 12, 2018)

Page Range		15845-15846
FR Document		2018-07543

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 71 (Thursday, April 12, 2018)

[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15845-15846]
From the Federal Register Online [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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 oira_submission@omb.eop.gov. 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,
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 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\
----------------------------------------------------------------------------------------------------------------
Annual Average
Activity Number of frequency per Total annual burden per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
Requests for tier-one DR 2 1 2 30 60
Requests for tier-two DR 1 1 1 8 8
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 68
----------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices 15845

Dated: April 6, 2018. FOR FURTHER INFORMATION CONTACT: to Pharmaceutical Current Good
Leslie Kux, Domini Bean, Office of Operations, Manufacturing Practice.’’ We intend the
Associate Commissioner for Policy. Food and Drug Administration, Three guidance to inform manufacturers of
[FR Doc. 2018–07544 Filed 4–11–18; 8:45 am] White Flint North, 10A–12M, 11601 veterinary and human drugs, including
BILLING CODE 4161–01–P
Landsdown St., North Bethesda, MD human biological drug products, on
20852, 301–796–5733, PRAStaff@ how to resolve disputes about scientific
fda.hhs.gov. and technical issues relating to current
DEPARTMENT OF HEALTH AND good manufacturing practice (CGMP).
SUPPLEMENTARY INFORMATION: In
HUMAN SERVICES Disputes related to scientific and
compliance with 44 U.S.C. 3507, FDA
technical issues may arise during FDA
Food and Drug Administration has submitted the following proposed
inspections of pharmaceutical
collection of information to OMB for
[Docket No. FDA–2014–N–1076] manufacturers to determine compliance
review and clearance.
with CGMP requirements or during
Agency Information Collection Guidance for Industry on Formal FDA’s assessment of corrective actions
Activities; Submission for Office of Dispute Resolution: Scientific and undertaken as a result of such
Management and Budget Review; Technical Issues Related to inspections. The guidance recommends
Comment Request; Guidance for Pharmaceutical Current Good procedures that we believe encourage
Industry on Formal Dispute Manufacturing Practice open and prompt discussion of disputes
Resolution: Scientific and Technical and lead to their resolution. The
OMB Control Number 0910–0563—
Issues Related to Pharmaceutical guidance describes procedures for
Extension
Current Good Manufacturing Practice raising such disputes to the Office of
Congress enacted section 562 of the Regulatory Affairs and Center levels and
AGENCY: Food and Drug Administration, Federal Food, Drug, and Cosmetic Act for requesting review by the dispute
HHS. (FD&C Act) (21 U.S.C. 360bbb–1), which resolution (DR) panel. The guidance is
ACTION: Notice. directed FDA to ensure that it had available on our website at: https://
adequate dispute resolution procedures www.fda.gov/downloads/drugs/
SUMMARY: The Food and Drug to provide for appropriate review of guidances/ucm070279.pdf, along with
Administration (FDA) is announcing scientific controversies between the additional information regarding the
that a proposed collection of FDA and members of regulated resolution of scientific disputes at FDA.
information has been submitted to the industry, including possible review by a In the Federal Register of October 27,
Office of Management and Budget scientific advisory committee. To 2017 (82 FR 49832), we published a
(OMB) for review and clearance under implement this provision, we amended notice soliciting public comment on the
the Paperwork Reduction Act of 1995. the general appeal regulation applicable proposed collection of information.
DATES: Fax written comments on the across all FDA components (21 CFR Although no comments were received,
collection of information by May 14, 10.75; Internal Agency review of we are reconsidering the usefulness of
2018. decisions) to provide for advisory the guidance document in light of
ADDRESSES: To ensure that comments on committee review (§ 10.75(b)(2)). At the changing Agency procedures. Consistent
the information collection are received, same time, and also consistent with the with our regulations at 21 CFR part
OMB recommends that written mandates of section 562 of the FD&C 10.115 we invite comment on our
comments be faxed to the Office of Act, we adopted an approach whereby guidance documents at any time.
Information and Regulatory Affairs, specific implementation procedures Ultimately, as our resources permit, we
OMB, Attn: FDA Desk Officer, Fax: 202– regarding scientific controversy hope to either revise, replace, or
395–7285, or emailed to oira_ associated with review of certain FDA withdraw the subject guidance
submission@omb.eop.gov. All decisions are detailed in center-issued document, however, until that time the
comments should be identified with the guidance. guidance remains available.
OMB control number 0910–0563. Also Accordingly, FDA developed the Accordingly, we are seeking to extend
include the FDA docket number found guidance entitled, ‘‘Guidance for OMB approval of the information
in brackets in the heading of this Industry on Formal Dispute Resolution: collection and estimate the burden as
document. Scientific and Technical Issues Related follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual Total Average
Number of frequency
Activity annual burden per Total hours
respondents per responses response
response

Requests for tier-one DR 2 1 2 30 60
Requests for tier-two DR 1 1 1 8 8

Total .............................................................................. ........................ ........................ ........................ ........................ 68
1 There are no capital costs or operating and maintenance costs associated with this collection.
sradovich on DSK3GMQ082PROD with NOTICES

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

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15846 Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices

estimate since the previous OMB in brackets in the heading of this requests for third-party inspection and
approval. document. may be found on the internet at https://
Dated: April 6, 2018. FOR FURTHER INFORMATION CONTACT:
www.fda.gov/downloads/Medical
Leslie Kux, Amber Sanford, Office of Operations, Devices/DeviceRegulationandGuidance/
Associate Commissioner for Policy. Food and Drug Administration, Three GuidanceDocuments/UCM085252.pdf.
White Flint North, 10A–12M, 11601 The guidance is intended to assist
[FR Doc. 2018–07543 Filed 4–11–18; 8:45 am]
Landsdown St., North Bethesda, MD device establishments in determining
BILLING CODE 4164–01–P
20852, 301–796–8867, PRAStaff@ whether they are eligible to participate
fda.hhs.gov. in the Accredited Persons (AP) Program
DEPARTMENT OF HEALTH AND and, if so, how to submit notification of
SUPPLEMENTARY INFORMATION: In their intent to use the program. The AP
HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA Program applies to manufacturers who
has submitted the following proposed currently market their medical devices
Food and Drug Administration
collection of information to OMB for in the United States and who also
[Docket No. FDA–2017–N–6162] review and clearance. market or plan to market their devices
Notification of the Intent To Use An in foreign countries. Such
Agency Information Collection
Accredited Person Under the manufacturers may need current
Activities; Submission for Office of
Accredited Persons Inspection Program inspections of their establishments to
Management and Budget Review;
operate in global commerce.
Comment Request; Notification of the OMB Control Number 0910–0569—
Intent To Use An Accredited Person There are approximately 8,000 foreign
Extension and 10,000 domestic manufacturers of
Under the Accredited Persons
Inspection Program Section 201 of the Medical Device medical devices. Approximately 5,000
User Fee and Modernization Act of 2002 of these firms only manufacture class I
AGENCY: Food and Drug Administration, (Pub. L. 107–250) amended section 704 devices and are, therefore, not eligible
HHS. of the Federal Food, Drug, and Cosmetic for the AP Program. In addition, 40
ACTION: Notice. Act by adding paragraph (g) (21 U.S.C. percent of the domestic firms do not
374(g)). This amendment authorized export devices and therefore are not
SUMMARY: The Food and Drug FDA to establish a voluntary third-party eligible to participate in the AP
Administration (FDA) is announcing inspection program applicable to Program. Further, 10 to 15 percent of the
that a proposed collection of manufacturers of class II or class III firms are not eligible due to the results
information has been submitted to the medical devices who meet certain of their previous inspection. FDA
Office of Management and Budget eligibility criteria. In 2007, the program estimates there are 4,000 domestic
(OMB) for review and clearance under was modified by the Food and Drug manufacturers and 4,000 foreign
the Paperwork Reduction Act of 1995. Administration Amendments Act of manufacturers that are eligible for
DATES: Fax written comments on the 2007 by revising eligibility criteria and inclusion under the AP Program. Based
collection of information by May 14, by no longer requiring prior approval by on communications with industry, FDA
2018. FDA. To reflect the revisions, FDA estimates that on an annual basis
ADDRESSES: To ensure that comments on modified the title of the collection of approximately 10 of these
the information collection are received, information and on March 2, 2009, manufacturers may use an AP in any
OMB recommends that written issued a guidance entitled given year.
comments be faxed to the Office of ‘‘Manufacturer’s Notification of the In the Federal Register of November
Information and Regulatory Affairs, Intent to Use an Accredited Person 21, 2017 (82 FR 55379), FDA published
OMB, Attn: FDA Desk Officer, Fax: 202– Under the Accredited Persons a 60-day notice requesting public
395–7285, or emailed to oira_ Inspection Program Authorized by comment on the proposed collection of
submission@omb.eop.gov. All Section 228 of the Food and Drug information. No comments were
comments should be identified with the Administration Amendments Act of received.
OMB control number 0910–0569. Also 2007.’’ This guidance superseded the FDA estimates the burden of this
include the FDA docket number found Agency’s previous guidance regarding collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 U.S.C. section responses per burden per Total hours
respondents responses
respondent response

Notification regarding use of an AP—374(g) ....................... 10 1 10 15 150
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Since the last approval of this notifications received in recent years. Dated: April 6, 2018.
information collection, we have updated This adjustment has resulted in a 150- Leslie Kux,
sradovich on DSK3GMQ082PROD with NOTICES

the estimated number of respondents hour reduction to the total hour burden Associate Commissioner for Policy.
from 20 to 10 respondents per year, estimate. [FR Doc. 2018–07619 Filed 4–11–18; 8:45 am]
based on the reduced number of BILLING CODE 4164–01–P

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Document Created: 2018-11-02 08:15:20
Document Modified: 2018-11-02 08:15:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by May 14, 2018.
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]
FR Citation		83 FR 15845

83 FR 15845 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 71 (April 12, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration