Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 513(g) Request for Information, 16865-16866 [2018-07980]
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Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
online screener will be asked to provide
their parents’ or guardians’ contact
information to provide parental consent
for the main survey. The process of
parents and guardians providing
consent for eligible youth will take
approximately 1 minute. For the fourth
and fifth post-test surveys, we estimate
that an additional 700 adults will be
contacted to provide consent for eligible
youth for a total of 11 additional burden
hours. Added to the original 6,000
parents and 100 burden hours, the total
number of parental online screeners and
consents will be 6,700 and the total
burden will be 111 hours.
With these additions, the estimated
number of voluntary respondents/
responses for all waves of data
collection for the study is 107,743, and
the total burden is estimated at 15,135
16865
hours—an estimated increase of 4,813
hours from the last approval.
In the Federal Register of December
26, 2017 (82 FR 61003), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was
received; however, this comment was
not PRA related.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of respondent/activity
Youth Mail screener-outcome survey ......................
Cross-Sectional Youth Refresher Sample, Post-test
and assent/consent process-outcome surveys 1–
5.
Youth Pre-test and assent/consent process-outcome survey.
Longitudinal Youth Cohort, Post-test and assent/
consent process-outcome surveys 1–5.
Youth Online screener-outcome survey ..................
Adult parental permission process-outcome survey
Total ..................................................................
1 There
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Total hours
1
1
23,685
4,920
0.0833 (5 minutes) ....
0.75 (45 minutes) ......
1,973
3,690
2,194
1
2,194
0.50 (30 minutes) ......
1,097
6,039
1
6,039
0.75 (45 minutes) ......
4,530
40,000
30,905
1
1
40,000
30,905
0.0833 (5 minutes) ....
0.0166 (1 minute) ......
3,332
513
107,743
........................
........................
....................................
15,135
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2014–N–0913]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; 513(g) Request for
Information
Food and Drug Administration,
HHS.
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 17,
2018.
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
Average burden per
response
23,685
4,920
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 0910–0705. Also
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2018–07971 Filed 4–16–18; 8:45 am]
ACTION:
Total annual
responses
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
ADDRESSES:
VerDate Sep<11>2014
19:20 Apr 16, 2018
Jkt 244001
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:
513(g) Request for Information
OMB Control Number 0910–0705—
Extension
This information collection supports
Agency regulations and accompanying
guidance. Section 513(g) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c(g)) provides
a means for obtaining the Agency’s
views about the classification and
regulatory requirements that may be
applicable to a particular device.
Section 513(g) provides that, within 60
days of the receipt of a written request
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
of any person for information respecting
the class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act, the
Secretary of Health and Human Services
shall provide such person a written
statement of the classification (if any) of
such device and the requirements of the
FD&C Act applicable to the device.
Regulations governing medical device
classification procedures are codified
under 21 CFR part 860.
The guidance document entitled
‘‘FDA and Industry Procedures for
Section 513(g) Requests for Information
Under the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry
and Food and Drug Administration
Staff’’ establishes procedures for
submitting, reviewing, and responding
to requests for information respecting
the class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act that are
submitted in accordance with section
513(g) of the FD&C Act. FDA does not
review data related to substantial
equivalence or safety and effectiveness
in a 513(g) request for information.
FDA’s responses to 513(g) requests for
information are not device classification
decisions and do not constitute FDA
clearance or approval for marketing.
Classification decisions and clearance or
approval for marketing require
submissions under different sections of
the FD&C Act.
E:\FR\FM\17APN1.SGM
17APN1
16866
Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
Relatedly, the FD&C Act, as amended
by the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85), requires FDA to collect user fees for
513(g) requests for information. The
guidance document entitled ‘‘Guidance
for Industry and Food and Drug
Administration Staff; User Fees for
513(g) Requests for Information’’ assists
FDA staff and regulated industry by
describing the user fees associated with
513(g) requests. The Medical Device
User Fee Cover Sheet (Form FDA 3601),
which accompanies the supplemental
material described in this information
collection is approved under OMB
control number 0910–0511.
In the Federal Register of November
21, 2017 (82 FR 55381) FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received in response to the notice.
We therefore retain the currently
approved burden estimate for the
information collection, which is as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
CDRH 513(g) requests ........................................................
CBER 513(g) requests .........................................................
114
4
1
1
114
4
12
12
1,368
48
Total ..............................................................................
........................
........................
........................
........................
1,416
1 There
are no capital costs of operating and maintenance costs associated with this collection off information.
Respondents to the collection of
information are mostly device
manufacturers; however, anyone may
submit a 513(g) request for information.
The total number of annual responses is
based on the average number of 513(g)
requests received each year by the
Agency.
Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07980 Filed 4–16–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0524]
Listing of Ingredients in Tobacco
Products; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a revised
final guidance for industry entitled
‘‘Listing of Ingredients in Tobacco
Products.’’ The revised guidance
document is intended to assist persons
making tobacco product ingredient
submissions to FDA as required by the
Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act).
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on April 17, 2018.
DATES:
VerDate Sep<11>2014
19:20 Apr 16, 2018
Jkt 244001
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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://
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.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
• 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–
2009–D–0524 for ‘‘Listing of Ingredients
in Tobacco Products.’’ 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
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
E:\FR\FM\17APN1.SGM
17APN1
]]>Agencies
[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16865-16866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07980]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0913]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 513(g) Request for
Information
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 17,
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 0910-0705.
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.
513(g) Request for Information
OMB Control Number 0910-0705--Extension
This information collection supports Agency regulations and
accompanying guidance. Section 513(g) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(g)) provides a means for
obtaining the Agency's views about the classification and regulatory
requirements that may be applicable to a particular device. Section
513(g) provides that, within 60 days of the receipt of a written
request of any person for information respecting the class in which a
device has been classified or the requirements applicable to a device
under the FD&C Act, the Secretary of Health and Human Services shall
provide such person a written statement of the classification (if any)
of such device and the requirements of the FD&C Act applicable to the
device. Regulations governing medical device classification procedures
are codified under 21 CFR part 860.
The guidance document entitled ``FDA and Industry Procedures for
Section 513(g) Requests for Information Under the Federal Food, Drug,
and Cosmetic Act; Guidance for Industry and Food and Drug
Administration Staff'' establishes procedures for submitting,
reviewing, and responding to requests for information respecting the
class in which a device has been classified or the requirements
applicable to a device under the FD&C Act that are submitted in
accordance with section 513(g) of the FD&C Act. FDA does not review
data related to substantial equivalence or safety and effectiveness in
a 513(g) request for information. FDA's responses to 513(g) requests
for information are not device classification decisions and do not
constitute FDA clearance or approval for marketing. Classification
decisions and clearance or approval for marketing require submissions
under different sections of the FD&C Act.
[[Page 16866]]
Relatedly, the FD&C Act, as amended by the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), requires FDA to
collect user fees for 513(g) requests for information. The guidance
document entitled ``Guidance for Industry and Food and Drug
Administration Staff; User Fees for 513(g) Requests for Information''
assists FDA staff and regulated industry by describing the user fees
associated with 513(g) requests. The Medical Device User Fee Cover
Sheet (Form FDA 3601), which accompanies the supplemental material
described in this information collection is approved under OMB control
number 0910-0511.
In the Federal Register of November 21, 2017 (82 FR 55381) FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received in response to the
notice.
We therefore retain the currently approved burden estimate for the
information collection, which is as follows:
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 513(g) requests............ 114 1 114 12 1,368
CBER 513(g) requests............ 4 1 4 12 48
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,416
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs of operating and maintenance costs associated with this collection off
information.
Respondents to the collection of information are mostly device
manufacturers; however, anyone may submit a 513(g) request for
information. The total number of annual responses is based on the
average number of 513(g) requests received each year by the Agency.
Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07980 Filed 4-16-18; 8:45 am]
BILLING CODE 4164-01-P
