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, 15845-15846 [2018-07543]
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15845
Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices
Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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.
[FR Doc. 2018–07544 Filed 4–11–18; 8:45 am]
BILLING CODE 4161–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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.
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.
SUMMARY:
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.
ADDRESSES:
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 (§ 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
Requests for tier-one DR
Requests for tier-two DR
sradovich on DSK3GMQ082PROD with NOTICES
Total
annual
responses
Average
burden per
response
Total hours
2
1
Total ..............................................................................
1
Annual
frequency
per
response
Number of
respondents
Activity
1
1
2
1
30
8
60
8
........................
........................
........................
........................
68
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)
VerDate Sep<11>2014
19:20 Apr 11, 2018
Jkt 244001
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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12APN1.SGM
12APN1
15846
Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices
estimate since the previous OMB
approval.
in brackets in the heading of this
document.
Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
[FR Doc. 2018–07543 Filed 4–11–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
[Docket No. FDA–2017–N–6162]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Notification of the
Intent To Use An Accredited Person
Under the Accredited Persons
Inspection Program
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 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 0910–0569. Also
include the FDA docket number found
SUMMARY:
Notification of the Intent To Use An
Accredited Person Under the
Accredited Persons Inspection Program
OMB Control Number 0910–0569—
Extension
Section 201 of the Medical Device
User Fee and Modernization Act of 2002
(Pub. L. 107–250) amended section 704
of the Federal Food, Drug, and Cosmetic
Act by adding paragraph (g) (21 U.S.C.
374(g)). This amendment authorized
FDA to establish a voluntary third-party
inspection program applicable to
manufacturers of class II or class III
medical devices who meet certain
eligibility criteria. In 2007, the program
was modified by the Food and Drug
Administration Amendments Act of
2007 by revising eligibility criteria and
by no longer requiring prior approval by
FDA. To reflect the revisions, FDA
modified the title of the collection of
information and on March 2, 2009,
issued a guidance entitled
‘‘Manufacturer’s Notification of the
Intent to Use an Accredited Person
Under the Accredited Persons
Inspection Program Authorized by
Section 228 of the Food and Drug
Administration Amendments Act of
2007.’’ This guidance superseded the
Agency’s previous guidance regarding
requests for third-party inspection and
may be found on the internet at https://
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/UCM085252.pdf.
The guidance is intended to assist
device establishments in determining
whether they are eligible to participate
in the Accredited Persons (AP) Program
and, if so, how to submit notification of
their intent to use the program. The AP
Program applies to manufacturers who
currently market their medical devices
in the United States and who also
market or plan to market their devices
in foreign countries. Such
manufacturers may need current
inspections of their establishments to
operate in global commerce.
There are approximately 8,000 foreign
and 10,000 domestic manufacturers of
medical devices. Approximately 5,000
of these firms only manufacture class I
devices and are, therefore, not eligible
for the AP Program. In addition, 40
percent of the domestic firms do not
export devices and therefore are not
eligible to participate in the AP
Program. Further, 10 to 15 percent of the
firms are not eligible due to the results
of their previous inspection. FDA
estimates there are 4,000 domestic
manufacturers and 4,000 foreign
manufacturers that are eligible for
inclusion under the AP Program. Based
on communications with industry, FDA
estimates that on an annual basis
approximately 10 of these
manufacturers may use an AP in any
given year.
In the Federal Register of November
21, 2017 (82 FR 55379), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/21 U.S.C. section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Notification regarding use of an AP—374(g) .......................
10
1
10
15
150
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last approval of this
information collection, we have updated
the estimated number of respondents
from 20 to 10 respondents per year,
based on the reduced number of
VerDate Sep<11>2014
19:20 Apr 11, 2018
Jkt 244001
notifications received in recent years.
This adjustment has resulted in a 150hour reduction to the total hour burden
estimate.
PO 00000
Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07619 Filed 4–11–18; 8:45 am]
BILLING CODE 4164–01–P
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Fmt 4703
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12APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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 [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\
----------------------------------------------------------------------------------------------------------------
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
