Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization, 51204-51205 [2016-18299]
Download as PDF
<![CDATA[
51204
Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1,2,3—Continued
Activity/21 CFR
section
FDA form
Number of
respondents
Annual reports—
1002.13(a)–(b).
3628—General ..................................
3634—TV ...........................................
3638—Diagnostic x-ray .....................
3641—Cabinet x-ray ..........................
3643—Microwave oven .....................
3636—Laser ......................................
3631—Sunlamp .................................
3647—Mercury vapor lamp ...............
3645—Ultrasonic therapy ..................
Number of
responses per
respondent
1,466
Total annual
responses
1
1,466
Average
burden per
response
18
Total hours
26,388
1 This table includes the recalculated burden estimate only for information collections (ICs) that are applicable to this draft guidance. It does not
include all ICs approved under OMB control number 0910–0025. The draft guidance, if finalized, would be a reduction to the burden estimate for
these ICs, except that the Abbreviated reports IC increases. We have described the overall reduction in the text of this document. However, to
avoid confusion, we have not included a total burden estimate in this table because such a total would include ICs that are not applicable to the
draft guidance.
2 There are no capital costs or operating and maintenance costs associated with this collection of information.
3 Totals may not sum due to rounding.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by OMB under the
PRA. The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073. The collections of
information in 21 CFR parts 1002
through 1050 are approved under OMB
control number 0910–0025.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
2, 2016.
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 0910–0131. Also
include the FDA docket number found
in brackets in the heading of this
document.
Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 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.
[FR Doc. 2016–18300 Filed 8–2–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agreement for Shipment of Devices for
Sterilization—21 CFR 801.150—OMB
Control Number 0910–0131—Extension
[Docket No. FDA–2013–N–0375]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Agreement for
Shipment of Devices for Sterilization
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
SUMMARY:
VerDate Sep<11>2014
18:21 Aug 02, 2016
Jkt 238001
Under sections 501(c) and 502(a) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 351(c)
and 352(a)), nonsterile devices that are
labeled as sterile but are in interstate
transit to a facility to be sterilized are
adulterated and misbranded. FDA
regulations in § 801.150(e) (21 CFR
801.150(e)) establish a control
mechanism by which firms may
manufacture and label medical devices
as sterile at one establishment and ship
the devices in interstate commerce for
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
sterilization at another establishment, a
practice that facilitates the processing of
devices and is economically necessary
for some firms.
Under § 801.150(e)(1), manufacturers
and sterilizers may sign an agreement
containing the following: (1)
Instructions for maintaining
accountability of the number of units in
each shipment, (2) acknowledgment that
the devices that are nonsterile are being
shipped for further processing, and (3)
specifications for sterilization
processing. This agreement allows the
manufacturer to ship misbranded
products to be sterilized without
initiating regulatory action and provides
FDA with a means to protect consumers
from use of nonsterile products. During
routine plant inspections, FDA normally
reviews agreements that must be kept
for 2 years after final shipment or
delivery of devices (§ 801.150(a)(2)).
The respondents to this collection of
information are device manufacturers
and contract sterilizers. FDA’s estimate
of the reporting burden is based on data
obtained from industry over the past
several years. It is estimated that each of
the firms subject to this requirement
prepares an average of 20 written
agreements each year. This estimate
varies greatly, from 1 to 100, because
some firms provide sterilization services
on a part-time basis for only one
customer, while others are large
facilities with many customers. The
average time required to prepare each
written agreement is estimated to be 4
hours. This estimate varies depending
on whether the agreement is the initial
agreement or an annual renewal, on the
format each firm elects to use, and on
the length of time required to reach
agreement. The estimate applies only to
those portions of the written agreement
that pertain to the requirements
E:\FR\FM\03AUN1.SGM
03AUN1
51205
Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
imposed by this regulation. The written
agreement generally also includes
contractual agreements that are a usual
and customary business practice. The
recordkeeping requirements of
§ 801.150(a)(2) consist of making copies
and maintaining the records required
under the third-party disclosure section
of this collection.
In the Federal Register of April 20,
2016 (81 FR 23309), 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 RECORDKEEPING BURDEN
Number of
recordkeepers
21 CFR section
Record retention, 801.150(a)(2) ..........................................
Number of
records per
recordkeeper
90
Total annual
records
20
Average
burden per
recordkeeping
(hours)
1,800
Total hours
.5
900
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of
respondents
Activity/21 CFR section
Agreement and labeling requirements, 801.150(e) .............
Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Office of the Secretary
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Delegation of Authorities
Notice is hereby given that I have
delegated to the Commissioner of Food
and Drugs (the Commissioner) those
authorities vested in the Secretary of the
Department of Health and Human
Services under sections 1002; 1003;
1004; 1005(f); and 1006(b) and (d) of the
Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85), which relate to the functions of the
Food and Drug Administration.
This authority may be re-delegated.
This delegation will be exercised in
accordance with the Department of
Health and Human Services’ applicable
policies, procedures, guidelines, and
regulations.
I ratify and affirm any actions taken
by the Commissioner or the
Commissioner’s subordinates that
involved the exercise of the authority
delegated herein prior to the effective
date of this delegation. This delegation
was effective on November 17, 2015.
VerDate Sep<11>2014
18:21 Aug 02, 2016
Jkt 238001
1,800
Total hours
4
7,200
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: July 28, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE P
20
Average
burden per
disclosure
(hours)
National Institutes of Health
BILLING CODE 4164–01–P
[FR Doc. 2016–18417 Filed 8–2–16; 8:45 am]
90
Total annual
disclosures
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–18299 Filed 8–2–16; 8:45 am]
Dated: July 27, 2016.
Sylvia M. Burwell,
Secretary.
Number of
disclosures
per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID SBIR Phase II
Clinical Trial Implementation (U44).
Date: August 30, 2016.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 3F100,
5601 Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Lynn Rust, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G42A, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, (240) 669–5069,
lrust@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
[FR Doc. 2016–18391 Filed 8–2–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
[Docket No. SAMHSA–2016–0002]
Request for Comment on Report
Entitled: Advancing the Care of
Pregnant and Parenting Women With
Opioid Use Disorder and Their Infants:
A Foundation for Clinical Guidance
Substance Abuse and Mental
Health Services Administration
(SAMHSA), Department of Health and
Human Services (HHS).
ACTION: Request for comment.
AGENCY:
SAMHSA, Center for
Substance Abuse Treatment (CSAT), in
HHS announces the opening of a docket
to obtain public comment on a report
entitled: Advancing the Care of Pregnant
and Parenting Women with Opioid Use
Disorder and their Infants: A
Foundation for Clinical Guidance.
This report describes the formal
process agreed on and followed under
the guidance of the federal steering
committee (FSC). It explains the RAND
Corporation (RAND)/University of
California Los Angeles (UCLA)
SUMMARY:
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Pages 51204-51205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18299]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0375]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Agreement for
Shipment of Devices for Sterilization
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
September 2, 2016.
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 0910-0131.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Agreement for Shipment of Devices for Sterilization--21 CFR 801.150--
OMB Control Number 0910-0131--Extension
Under sections 501(c) and 502(a) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 351(c) and 352(a)), nonsterile
devices that are labeled as sterile but are in interstate transit to a
facility to be sterilized are adulterated and misbranded. FDA
regulations in Sec. 801.150(e) (21 CFR 801.150(e)) establish a control
mechanism by which firms may manufacture and label medical devices as
sterile at one establishment and ship the devices in interstate
commerce for sterilization at another establishment, a practice that
facilitates the processing of devices and is economically necessary for
some firms.
Under Sec. 801.150(e)(1), manufacturers and sterilizers may sign
an agreement containing the following: (1) Instructions for maintaining
accountability of the number of units in each shipment, (2)
acknowledgment that the devices that are nonsterile are being shipped
for further processing, and (3) specifications for sterilization
processing. This agreement allows the manufacturer to ship misbranded
products to be sterilized without initiating regulatory action and
provides FDA with a means to protect consumers from use of nonsterile
products. During routine plant inspections, FDA normally reviews
agreements that must be kept for 2 years after final shipment or
delivery of devices (Sec. 801.150(a)(2)).
The respondents to this collection of information are device
manufacturers and contract sterilizers. FDA's estimate of the reporting
burden is based on data obtained from industry over the past several
years. It is estimated that each of the firms subject to this
requirement prepares an average of 20 written agreements each year.
This estimate varies greatly, from 1 to 100, because some firms provide
sterilization services on a part-time basis for only one customer,
while others are large facilities with many customers. The average time
required to prepare each written agreement is estimated to be 4 hours.
This estimate varies depending on whether the agreement is the initial
agreement or an annual renewal, on the format each firm elects to use,
and on the length of time required to reach agreement. The estimate
applies only to those portions of the written agreement that pertain to
the requirements
[[Page 51205]]
imposed by this regulation. The written agreement generally also
includes contractual agreements that are a usual and customary business
practice. The recordkeeping requirements of Sec. 801.150(a)(2) consist
of making copies and maintaining the records required under the third-
party disclosure section of this collection.
In the Federal Register of April 20, 2016 (81 FR 23309), 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 Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
21 CFR section recordkeepers records per records recordkeeping Total hours
recordkeeper (hours)
----------------------------------------------------------------------------------------------------------------
Record retention, 801.150(a)(2). 90 20 1,800 .5 900
----------------------------------------------------------------------------------------------------------------
Table 2--Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR section Number of disclosures Total annual per disclosure Total hours
respondents per respondent disclosures (hours)
----------------------------------------------------------------------------------------------------------------
Agreement and labeling 90 20 1,800 4 7,200
requirements, 801.150(e).......
----------------------------------------------------------------------------------------------------------------
Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18299 Filed 8-2-16; 8:45 am]
BILLING CODE 4164-01-P
