Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes, 34399-34400 [2019-15270]
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Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices
These estimates are based on our
experience with medicated feed mill
license applications. We estimate that
we will receive 14 medicated feed mill
license applications, 54 supplemental
applications, 29 requests for voluntary
revocation, and that these submissions
will take approximately 15 minutes per
response, as shown in table 1, rows 1
through 3. We estimate that preparing a
request for a hearing under § 515.30(c)
takes approximately 4 hours, as shown
in table 1, row 4. In table 2, we estimate
that 837 licensees will keep the records
required by 21 CFR 510.305, expending
a total of 25 hours annually.
Our estimated burden for the
information collection reflects an
overall decrease of 2 hours and a
corresponding decrease of 56 responses/
records. We attribute this adjustment to
a net decrease in the number of
submissions we received over the last
few years.
Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15284 Filed 7–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0893]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Center for Devices
and Radiological Health Appeals
Processes
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 August 19,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:56 Jul 17, 2019
Jkt 247001
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 0910–0738. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
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:
Center for Devices and Radiological
Health Appeals Processes
OMB Control Number 0910–0738—
Extension
The guidance document entitled
‘‘Guidance for Industry and Food and
Drug Administration Staff; Center for
Devices and Radiological Health
Appeals Processes’’ 1 describes the
processes available to outside
stakeholders to request additional
review of decisions or actions by Center
for Devices and Radiological Health
(CDRH) employees. FDA is seeking
approval for the reporting burden
associated with requests for additional
review of decisions and actions by
CDRH employees as described in the
guidance.
Individuals outside of FDA who
disagree with a decision or action taken
by CDRH and wish to have it reviewed
or reconsidered have several processes
for resolution from which to choose,
including requests for supervisory
review of an action, petitions, and
hearings. Of these, by far the most
commonly used is a request for
supervisory review under § 10.75 (21
CFR 10.75) (‘‘10.75 appeal’’). Section
517A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360g–1), added by section 603 of the
Food and Drug Administration Safety
and Innovation Act, includes
requirements pertaining to the process
1 https://www.fda.gov/ucm/groups/fdagov-public/
@fdagov-meddev-gen/documents/document/
ucm284670.pdf.
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Fmt 4703
Sfmt 4703
34399
and timelines for 10.75 appeals of
‘‘significant decisions’’ regarding 510(k)
premarket notifications, applications for
premarket approvals (PMAs), and
applications for investigational device
exemptions (IDEs).
A request for review under § 10.75
should be based on the information that
was already present in the
administrative file at the time of the
decision that is being reviewed as
provided in § 10.75(d). Section 517A of
the FD&C Act refers to significant
decisions regarding the information in
the administrative file for premarket
notification (section 510(k) of the FD&C
Act (21 U.S.C. 360(k))), PMA (section
515 (21 U.S.C. 360e)), and IDE (section
520(g) (21 U.S.C. 360j(g))) submissions
that is collected under existing
regulations that specify the information
manufacturers must submit so that FDA
may properly evaluate the safety and
effectiveness of medical devices. The
information collections associated with
these regulations are currently approved
by the OMB as follows: The collections
of information in 21 CFR part 807,
subpart E (premarket notification) have
been approved under OMB control
number 0910–0120; the collections of
information in 21 CFR part 814
(premarket approval) have been
approved under OMB control number
0910–0231; and the collections of
information in 21 CFR part 812
(investigational device exemption) have
been approved under OMB control
number 0910–0078.
While CDRH already possesses in the
administrative file the information that
would form the basis of a decision on
a matter under appeal, the submission
of particular information regarding the
request itself and the data and
information relied on by the requestor
in the appeal would facilitate timely
resolution of the decision under review.
The guidance describes the collection of
information not expressly specified
under existing regulations such as the
submission of the request for review,
minor clarifications as part of the
request, and supporting information.
In the Federal Register of March 8,
2019 (84 FR 8530), FDA published a 60day 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:
E:\FR\FM\18JYN1.SGM
18JYN1
34400
Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
CDRH Appeals Processes Guidance Document ................
35
1
35
8
280
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects a
decrease of 15 responses and a
corresponding overall decrease of 120
hours. We attribute this adjustment to a
decrease in the number of submissions
we received over the last few years.
Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15270 Filed 7–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–2808]
Advanced Prostate Cancer:
Developing Gonadotropin-Releasing
Hormone Analogues; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Advanced Prostate Cancer: Developing
Gonadotropin-Releasing Hormone
Analogues.’’ This draft guidance
describes the FDA’s current
recommendations regarding the overall
development program and clinical trial
designs for developing gonadotropinreleasing hormone (GnRH) analogues to
treat advanced prostate cancer.
DATES: Submit either electronic or
written comments on the draft guidance
by September 16, 2019 to ensure that
the Agency considers your comment on
this draft guidance before it begins work
on the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
VerDate Sep<11>2014
17:56 Jul 17, 2019
Jkt 247001
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–2808 for ‘‘Advanced Prostate
Cancer: Developing GonadotropinReleasing Hormone Analogues.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Elaine Chang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
E:\FR\FM\18JYN1.SGM
18JYN1
]]>Agencies
[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34399-34400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15270]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0893]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Center for Devices
and Radiological Health Appeals Processes
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 August
19, 2019.
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 0910-0738.
Also include the FDA docket number found in brackets in the heading of
this document.
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,
[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.
Center for Devices and Radiological Health Appeals Processes
OMB Control Number 0910-0738--Extension
The guidance document entitled ``Guidance for Industry and Food and
Drug Administration Staff; Center for Devices and Radiological Health
Appeals Processes'' \1\ describes the processes available to outside
stakeholders to request additional review of decisions or actions by
Center for Devices and Radiological Health (CDRH) employees. FDA is
seeking approval for the reporting burden associated with requests for
additional review of decisions and actions by CDRH employees as
described in the guidance.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm284670.pdf.
---------------------------------------------------------------------------
Individuals outside of FDA who disagree with a decision or action
taken by CDRH and wish to have it reviewed or reconsidered have several
processes for resolution from which to choose, including requests for
supervisory review of an action, petitions, and hearings. Of these, by
far the most commonly used is a request for supervisory review under
Sec. [thinsp]10.75 (21 CFR 10.75) (``10.75 appeal''). Section 517A of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360g-1),
added by section 603 of the Food and Drug Administration Safety and
Innovation Act, includes requirements pertaining to the process and
timelines for 10.75 appeals of ``significant decisions'' regarding
510(k) premarket notifications, applications for premarket approvals
(PMAs), and applications for investigational device exemptions (IDEs).
A request for review under Sec. [thinsp]10.75 should be based on
the information that was already present in the administrative file at
the time of the decision that is being reviewed as provided in Sec.
[thinsp]10.75(d). Section 517A of the FD&C Act refers to significant
decisions regarding the information in the administrative file for
premarket notification (section 510(k) of the FD&C Act (21 U.S.C.
360(k))), PMA (section 515 (21 U.S.C. 360e)), and IDE (section 520(g)
(21 U.S.C. 360j(g))) submissions that is collected under existing
regulations that specify the information manufacturers must submit so
that FDA may properly evaluate the safety and effectiveness of medical
devices. The information collections associated with these regulations
are currently approved by the OMB as follows: The collections of
information in 21 CFR part 807, subpart E (premarket notification) have
been approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814 (premarket approval) have been approved
under OMB control number 0910-0231; and the collections of information
in 21 CFR part 812 (investigational device exemption) have been
approved under OMB control number 0910-0078.
While CDRH already possesses in the administrative file the
information that would form the basis of a decision on a matter under
appeal, the submission of particular information regarding the request
itself and the data and information relied on by the requestor in the
appeal would facilitate timely resolution of the decision under review.
The guidance describes the collection of information not expressly
specified under existing regulations such as the submission of the
request for review, minor clarifications as part of the request, and
supporting information.
In the Federal Register of March 8, 2019 (84 FR 8530), 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:
[[Page 34400]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Appeals Processes Guidance Document........................... 35 1 35 8 280
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects a
decrease of 15 responses and a corresponding overall decrease of 120
hours. We attribute this adjustment to a decrease in the number of
submissions we received over the last few years.
Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15270 Filed 7-17-19; 8:45 am]
BILLING CODE 4164-01-P
