Semipostal Stamp Program, 3762-3763 [2016-01070]
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Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Proposed Rules
27. Weiss, M., ‘‘The Treatment of Insomnia
Through the Use of Electrosleep: An EEG
Study.’’ Journal of Nervous and Mental
Disease 157(2):108–120, 1973.
28. Coursey, R.D., B.L. Frankel, K.R. Gaarder,
D.E. Mott, ‘‘A Comparison of Relaxation
Techniques With Electrosleep Therapy
for Chronic, Sleep-Onset Insomnia: A
Sleep-EEG Study.’’ Biofeedback and SelfRegulation 5(1):57–73, 1980.
29. Cartwright, R.D., M.F. Weiss, ‘‘The Effects
of Electrosleep on Insomnia Revisited.’’
Journal of Nervous and Mental Disease
161(2):134–137, 1975.
30. Itil, T., P. Gannon, S. Akpinar, W. Hsu,
‘‘Quantitative EEG Analysis of
Electrosleep Using Analog Frequency
Analyzer and Digital Computer
Methods.’’ Diseases of the Nervous
System 33(6):376–381, 1972.
31. Empson, J.A., ‘‘Does Electrosleep Induce
Natural Sleep?’’ Electroencephalography
and Clinical Neurophysiology 35(6):663–
664, 1973.
32. Frankel, B.L., R. Buchbinder, F. Snyder,
‘‘Ineffectiveness of Electrosleep in
Chronic Primary Insomnia.’’ Archives of
General Psychiatry 29(4):563–568, 1973.
33. Nagata, K., Y. Morita, H. Seno, J.
Matsumoto, ‘‘Studies of Electrosleep on
Normal Adults, Insomniacs, and
Hypertensive Patients.’’ Tokushima
Journal of Experimental Medicine 28(3–
4):69–83, 1981.
34. Lande, R.G., C. Gragnani, ‘‘Efficacy of
Cranial Electric Stimulation for the
Treatment of Insomnia: A Randomized
Pilot Study.’’ Complementary Therapies
in Medicine 21:8–13, 2013.
35. Barclay, T.H., R.D. Barclay, ‘‘A Clinical
Trial of Cranial Electrotherapy
Stimulation for Anxiety and Comorbid
Depression.’’ Journal of Affective
Disorders 164:171–177, 2014.
36. Pain Management Task Force, Final
Report, May 2010. Office of The Army
Surgeon General.
37. Marshall, A.G., C.E. Izard, ‘‘Cerebral
Electrotherapeutic Treatment of
Depressions.’’ Journal of Consulting and
Clinical Psychology 42(1):93–97, 1974.
List of Subjects in 21 CFR Part 882
Medical devices, Neurological
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, it is proposed that
21 CFR part 882 be amended as follows:
PART 882—NEUROLOGICAL DEVICES
1. The authority citation for 21 CFR
part 882 continues to read as follows:
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■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Revise § 882.5800 to read as
follows:
■
§ 882.5800 Cranial electrotherapy
stimulator.
(a) Identification. A cranial
electrotherapy stimulator is a
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prescription device that applies
electrical current that is not intended to
induce a seizure to a patient’s head to
treat psychiatric conditions.
(b) Classification. (1) Class II (special
controls) when intended to treat
insomnia and/or anxiety. The special
controls for this device are:
(i) A detailed summary of the clinical
testing pertinent to use of the device to
demonstrate the effectiveness of the
device when intended to treat insomnia
and/or anxiety.
(ii) Components of the device that
come into human contact must be
demonstrated to be biocompatible.
(iii) The device must be designed and
tested for electrical safety and
electromagnetic compatibility (EMC) in
its intended use environment.
(iv) Appropriate software verification,
validation, and hazard analysis must be
performed.
(v) The technical parameters of the
device, including waveform, output
mode, pulse duration, frequency, train
delivery, maximum charge and energy,
must be fully characterized and verified.
(vi) The labeling for the device must
include the following:
(A) The intended use population and
the intended use environment.
(B) A warning that patients should be
monitored by their physician for signs
of worsening.
(C) A warning that instructs patients
on how to mitigate the risk of
headaches, and what to do should a
headache occur.
(D) A warning that instructs patients
on how to mitigate the risk of dizziness,
and what to do should dizziness occur.
(E) A detailed summary of the clinical
testing, which includes the clinical
outcomes associated with the use of the
device, and a summary of adverse
events and complications that occurred
with the device.
(F) Instructions for use that address
where to place the electrodes, what
stimulation parameters to use, and
duration and frequency of treatment
sessions. This information must be
based on the results of clinical studies
for the device.
(G) A detailed summary of the device
technical parameters, including
waveform, output mode, pulse duration,
frequency, train delivery, and maximum
charge and energy.
(H) Information on validated methods
for reprocessing any reusable
components between uses.
(vii) Cranial electrotherapy stimulator
devices marketed prior to the effective
date of this reclassification must have
an amendment submitted to the
previously cleared premarket
notification (510(k)) demonstrating
compliance with these special controls.
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Fmt 4702
Sfmt 4702
(2) Class III (premarket approval)
when intended to treat depression.
(c) Date premarket approval
application (PMA) or notice of
completion of product development
protocol (PDP) is required. A PMA or
notice of completion of a PDP is
required to be filed with the Food and
Drug Administration on or before [A
DATE WILL BE ADDED 90 DAYS
AFTER DATE OF PUBLICATION OF A
FUTURE FINAL ORDER IN THE
FEDERAL REGISTER], for any cranial
electrotherapy stimulator device with an
intended use described in (b)(3) of this
section, that was in commercial
distribution before May 28, 1976, or that
has, on or before [A DATE WILL BE
ADDED 90 DAYS AFTER DATE OF
PUBLICATION OF A FUTURE FINAL
ORDER IN THE FEDERAL REGISTER],
been found to be substantially
equivalent to any cranial electrotherapy
stimulator device with an intended use
described in paragraph (b)(3) of this
section, that was in commercial
distribution before May 28, 1976. Any
other cranial electrotherapy stimulator
device with an intended use described
in paragraph (b)(3) of this section shall
have an approved PMA or declared
completed PDP in effect before being
placed in commercial distribution.
Dated: January 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01173 Filed 1–21–16; 8:45 am]
BILLING CODE 4164–01–P
POSTAL SERVICE
39 CFR Part 551
Semipostal Stamp Program
Postal ServiceTM.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
remove certain restrictions on the
commencement date for the Postal
Service’s discretionary Semipostal
Stamp Program, and clarify how many
semipostal stamps issued under that
program may be on sale at any one time.
DATES: Comments must be received on
or before February 22, 2016.
FOR FURTHER INFORMATION CONTACT: Lori
Mazzone, Manager, Stamp Products &
Exhibitions, 202–268–6711,
lori.l.mazzone@usps.gov.
SUPPLEMENTARY INFORMATION:
Pursuant to the Semipostal
Authorization Act, Public Law 106–253,
the Postal Service has been granted
discretionary authority to issue and sell
semipostal stamps to advance such
SUMMARY:
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22JAP1
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Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Proposed Rules
causes as it considers to be ‘‘in the
national public interest and
appropriate.’’ See 39 U.S.C. 416(b). On
June 12, 2001, the Postal Service
published a final rule establishing the
regulations in 39 CFR part 551 for the
discretionary Semipostal Stamp
Program (66 FR 31826). Minor revisions
were made to these regulations to
implement Public Law 107–67, 115 Stat.
514 (2001), and to reflect minor
organizational changes in the Postal
Service (67 FR 5215 (February 5, 2002)).
On February 19, 2004, the Postal Service
published a final rule clarifying the
cost-offset policy for semipostal stamps
(69 FR 7688), and on February 9, 2005,
the Postal Service also published an
additional minor clarifying revision to
these cost-offset regulations (70 FR
6764).
The Postal Service now proposes to
revise paragraphs (a) and (b) of 39 CFR
551.5. A brief description of each
proposed change follows.
The proposed revision of § 551.5(a)
would remove certain restrictions on the
commencement date of the
discretionary Semipostal Stamp
Program. Under current regulations, the
10-year period for the discretionary
semipostal stamp program commences
on a date determined by the Office of
Stamp Services, but that date must be
after the sales period of the Breast
Cancer Research Stamp (BCRS) is
concluded. Most recently, Public Law
114–99 (December 11, 2015) extended
that sales period to December 31, 2019.
The proposed revision of § 551.5(a)
would specify that the 10-year period
will commence on a date determined by
the Office of Stamp Services, but this
date need not be after the BCRS sale
period concludes.
The proposed revision of § 551.5(b)
would clarify that although only one
semipostal stamp under the
discretionary Semipostal Stamp
Program under 39 U.S.C. 416 (a
‘‘discretionary program semipostal
stamp’’) will be offered for sale at any
one time, other semipostal stamps
required to be issued by Congress (such
as the BCRS) may be on sale when a
discretionary program semipostal stamp
is on sale. Current regulations state that
the Postal Service will offer only one
semipostal stamp for sale at any given
time during the 10-year period (not
specifying whether it is a discretionary
program semipostal stamp or a
semipostal stamp required by Congress).
The proposed revision of § 551.5(b)
would clarify that the one-at-a-time
limitation on the sale of semipostal
stamps applies only to discretionary
program semipostal stamps.
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We will publish an appropriate
amendment to 39 CFR part 551 to reflect
these changes if the proposal is adopted.
List of Subjects in 39 CFR Part 551
Administrative practice and
procedure.
In accordance with 39 U.S.C.
416(e)(2), the Postal Service invites
public comment on the following
proposed amendments to the Code of
Federal Regulations. For the reasons
stated in the preamble, the Postal
Service proposes to revise 39 CFR part
551 as follows:
PART 551—SEMIPOSTAL STAMP
PROGRAM
1. The authority citation for 39 CFR
part 551 continues to read as follows:
■
Authority: 39 U.S.C. 101, 201, 203, 401,
403, 404, 410, 414, 416.
2. In § 551.5, revise paragraphs (a) and
(b) to read as follows:
■
§ 551.5
Frequency and other limitations.
(a) The Postal Service is authorized to
issue semipostal stamps for a 10-year
period beginning on the date on which
semipostal stamps are first sold to the
public under 39 U.S.C. 416. The Office
of Stamp Services will determine the
date of commencement of the 10-year
period.
(b) The Postal Service will offer only
one semipostal stamp pursuant to the
discretionary semipostal stamp program
under 39 U.S.C. 416 for sale at any given
time during the 10-year period.
*
*
*
*
*
Stanley F. Mires,
Attorney, Federal Compliance.
[FR Doc. 2016–01070 Filed 1–21–16; 8:45 am]
BILLING CODE 7710–12–P
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
48 CFR Parts 3, 4, and 52
[FAR Case 2015–012; Docket No. 2015–
0012; Sequence No. 1]
RIN 9000–AN04
Federal Acquisition Regulation:
Contractor Employee Internal
Confidentiality Agreements
Department of Defense (DoD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
AGENCY:
PO 00000
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Fmt 4702
Sfmt 4702
ACTION:
3763
Proposed rule.
DoD, GSA, and NASA are
proposing to amend the Federal
Acquisition Regulation (FAR) to
implement a section of the Consolidated
and Further Continuing Appropriations
Act, 2015, that prohibits the use of
funds, appropriated or otherwise made
available, for a contract with an entity
that requires employees or
subcontractors to sign an internal
confidentiality agreement that restricts
such employees or subcontractors from
lawfully reporting waste, fraud, or abuse
to a designated Government
representative authorized to receive
such information.
DATES: Interested parties should submit
written comments to the Regulatory
Secretariat at one of the addresses
shown below on or before March 22,
2016 to be considered in the formation
of the final rule.
ADDRESSES: Submit comments in
response to FAR Case 2015–012 by any
of the following methods:
• Regulations.gov: https://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching for ‘‘FAR Case 2015–012’’.
Select the link ‘‘Comment Now’’ that
corresponds with FAR Case 2015–012.
Follow the instructions provided on the
screen. Please include your name,
company name (if any), and ‘‘FAR Case
2015–012’’ on your attached
document(s).
• Mail: General Services
Administration, Regulatory Secretariat
(MVCB), ATTN: Ms. Flowers, 1800 F
Street NW., 2nd Floor, Washington, DC
20405–0001.
Instructions: Please submit comments
only and cite ‘‘FAR Case 2015–012’’ in
all correspondence related to this case.
All comments received will be posted
without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT: Ms.
Cecelia L. Davis, Procurement Analyst,
at 202–219–0202 for clarification of
content. For information pertaining to
status or publication schedules, contact
the Regulatory Secretariat at 202–501–
4755. Please cite FAR Case 2015–012.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
This proposed rule revises the FAR to
implement section 743 of Division E,
E:\FR\FM\22JAP1.SGM
22JAP1
]]>Agencies
[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Proposed Rules]
[Pages 3762-3763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01070]
=======================================================================
-----------------------------------------------------------------------
POSTAL SERVICE
39 CFR Part 551
Semipostal Stamp Program
AGENCY: Postal ServiceTM.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would remove certain restrictions on the
commencement date for the Postal Service's discretionary Semipostal
Stamp Program, and clarify how many semipostal stamps issued under that
program may be on sale at any one time.
DATES: Comments must be received on or before February 22, 2016.
FOR FURTHER INFORMATION CONTACT: Lori Mazzone, Manager, Stamp Products
& Exhibitions, 202-268-6711, lori.l.mazzone@usps.gov.
SUPPLEMENTARY INFORMATION:
Pursuant to the Semipostal Authorization Act, Public Law 106-253,
the Postal Service has been granted discretionary authority to issue
and sell semipostal stamps to advance such
[[Page 3763]]
causes as it considers to be ``in the national public interest and
appropriate.'' See 39 U.S.C. 416(b). On June 12, 2001, the Postal
Service published a final rule establishing the regulations in 39 CFR
part 551 for the discretionary Semipostal Stamp Program (66 FR 31826).
Minor revisions were made to these regulations to implement Public Law
107-67, 115 Stat. 514 (2001), and to reflect minor organizational
changes in the Postal Service (67 FR 5215 (February 5, 2002)). On
February 19, 2004, the Postal Service published a final rule clarifying
the cost-offset policy for semipostal stamps (69 FR 7688), and on
February 9, 2005, the Postal Service also published an additional minor
clarifying revision to these cost-offset regulations (70 FR 6764).
The Postal Service now proposes to revise paragraphs (a) and (b) of
39 CFR 551.5. A brief description of each proposed change follows.
The proposed revision of Sec. 551.5(a) would remove certain
restrictions on the commencement date of the discretionary Semipostal
Stamp Program. Under current regulations, the 10-year period for the
discretionary semipostal stamp program commences on a date determined
by the Office of Stamp Services, but that date must be after the sales
period of the Breast Cancer Research Stamp (BCRS) is concluded. Most
recently, Public Law 114-99 (December 11, 2015) extended that sales
period to December 31, 2019.
The proposed revision of Sec. 551.5(a) would specify that the 10-
year period will commence on a date determined by the Office of Stamp
Services, but this date need not be after the BCRS sale period
concludes.
The proposed revision of Sec. 551.5(b) would clarify that although
only one semipostal stamp under the discretionary Semipostal Stamp
Program under 39 U.S.C. 416 (a ``discretionary program semipostal
stamp'') will be offered for sale at any one time, other semipostal
stamps required to be issued by Congress (such as the BCRS) may be on
sale when a discretionary program semipostal stamp is on sale. Current
regulations state that the Postal Service will offer only one
semipostal stamp for sale at any given time during the 10-year period
(not specifying whether it is a discretionary program semipostal stamp
or a semipostal stamp required by Congress).
The proposed revision of Sec. 551.5(b) would clarify that the one-
at-a-time limitation on the sale of semipostal stamps applies only to
discretionary program semipostal stamps.
We will publish an appropriate amendment to 39 CFR part 551 to
reflect these changes if the proposal is adopted.
List of Subjects in 39 CFR Part 551
Administrative practice and procedure.
In accordance with 39 U.S.C. 416(e)(2), the Postal Service invites
public comment on the following proposed amendments to the Code of
Federal Regulations. For the reasons stated in the preamble, the Postal
Service proposes to revise 39 CFR part 551 as follows:
PART 551--SEMIPOSTAL STAMP PROGRAM
0
1. The authority citation for 39 CFR part 551 continues to read as
follows:
Authority: 39 U.S.C. 101, 201, 203, 401, 403, 404, 410, 414,
416.
0
2. In Sec. 551.5, revise paragraphs (a) and (b) to read as follows:
Sec. 551.5 Frequency and other limitations.
(a) The Postal Service is authorized to issue semipostal stamps for
a 10-year period beginning on the date on which semipostal stamps are
first sold to the public under 39 U.S.C. 416. The Office of Stamp
Services will determine the date of commencement of the 10-year period.
(b) The Postal Service will offer only one semipostal stamp
pursuant to the discretionary semipostal stamp program under 39 U.S.C.
416 for sale at any given time during the 10-year period.
* * * * *
Stanley F. Mires,
Attorney, Federal Compliance.
[FR Doc. 2016-01070 Filed 1-21-16; 8:45 am]
BILLING CODE 7710-12-P
