Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification; Reopening of the Comment Period, 44172-44173 [2010-18405]
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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Proposed Rules
own business proprietary information,
on persons on the APO service list, or
the public version of such a document
on persons on the public service list,
may be made by facsimile transmission
or other electronic transmission process,
with the consent of the person to be
served.
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(g) Certifications. A person must file
with each submission containing factual
information the certification in
paragraph (g)(1) of this section and, in
addition, if the person has legal counsel
or another representative, the
certification in paragraph (g)(2) of this
section:
(1) For the person officially
responsible for presentation of the
factual information:
I, (name and title), currently employed by
(person), certify that (1) I have read the
attached submission, and (2) the information
contained in this submission is, to the best
of my knowledge, complete and accurate.
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6. Section 351.304 is amended by
revising paragraphs (b), (c), (d)(1)
introductory text and (d)(1)(iv) to read
as follows:
§ 351.304 Establishing business
proprietary treatment of information.
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(b) Identification of business
proprietary information—(1) In general.
A person submitting information must
identify the information for which it
claims business proprietary treatment
by enclosing the information within
single brackets. The submitting person
must provide with the information an
explanation of why each item of
bracketed information is entitled to
business proprietary treatment. A
person submitting a request for business
proprietary treatment also must include
an agreement to permit disclosure under
an administrative protective order,
unless the submitting party claims that
there is a clear and compelling need to
withhold the information from
disclosure under an administrative
protective order.
(2) Information claimed to be exempt
from disclosure under administrative
protective order. (i) If the submitting
person claims that there is a clear and
compelling need to withhold certain
information from disclosure under an
administrative protective order (see
paragraph (a)(1)(ii) of this section), the
submitting person must identify the
information by enclosing the
information within double brackets, and
must include a full explanation of the
reasons for the claim.
(ii) In an investigation, the submitting
person may enclose business
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proprietary customer names within
double brackets (see paragraph (a)(1)(iii)
of this section).
(iii) The submitting person may
exclude the information in double
brackets from the Business Proprietary/
APO Version of the submission served
on authorized applicants. See § 351.303
for filing and service requirements.
(c) Public version. (1) A person filing
a submission that contains information
for which business proprietary
treatment is claimed must file a public
version of the submission. The public
version must be filed on the first
business day after the filing deadline for
the business proprietary document (see
§ 351.303(b)). The public version must
contain a summary of the bracketed
information in sufficient detail to permit
a reasonable understanding of the
substance of the information. If the
submitting person claims that
summarization is not possible, the claim
must be accompanied by a full
explanation of the reasons supporting
that claim. Generally, numerical data
will be considered adequately
summarized if grouped or presented in
terms of indices or figures within 10
percent of the actual figure. If an
individual portion of the numerical data
is voluminous, at least one percent
representative of that portion must be
summarized. A submitter should not
create a public summary of business
proprietary information of another
person.
(2) If a submitting party discovers that
it has failed to bracket information
correctly, the submitter may file a
complete, corrected business
proprietary document along with the
public version (see § 351.303(b)). At the
close of business on the day on which
the public version of a submission is
due under paragraph (c)(2) of this
section, however, the bracketing of
business proprietary information in the
original business proprietary document
or, if a corrected version is timely filed,
the corrected business proprietary
document will become final. Once
bracketing has become final, the
Secretary will not accept any further
corrections to the bracketing of
information in a submission, and the
Secretary will treat non-bracketed
information as public information.
(d) * * *
(1) In general. The Secretary will
reject a submission that does not meet
the requirements of section 777(b) of the
Act and this section with a written
explanation. The submitting person may
take any of the following actions within
two business days after receiving the
Secretary’s explanation:
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(iv) Submit other material concerning
the subject matter of the rejected
information. If the submitting person
does not take any of these actions, the
Secretary will not consider the rejected
submission.
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[FR Doc. 2010–18389 Filed 7–27–10; 8:45 am]
BILLING CODE 3510–DS–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 890
[Docket No. FDA–2009–N–0493]
RIN 0910–ZA37
Neurological and Physical Medicine
Devices; Designation of Special
Controls for Certain Class II Devices
and Exemption From Premarket
Notification; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Proposed rule; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening until
September 7, 2010, the comment period
for the proposed rule published in the
Federal Register of April 5, 2010 (75 FR
17093). The document proposed to
amend certain neurological and
physical medicine device regulations to
establish special controls for these class
II devices and to exempt some of these
devices from premarket notification
requirements. FDA is reopening the
comment period to allow further
comment and to receive any new
information.
SUMMARY:
Submit electronic or written
comments by September 7, 2010.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2009–N–
0493, and/or RIN number 0910–ZA37,
by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD—ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
DATES:
E:\FR\FM\28JYP1.SGM
28JYP1
Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Proposed Rules
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the agency name and
Docket No. and Regulatory Information
Number (RIN) (if a RIN number has been
assigned) for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
in the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
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 Division of Dockets
Management, 5630 Fishers Lane,
rm.1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Robert J. DeLuca, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. G214, Silver Spring,
MD 20993–0002, email:
Robert.DeLuca@fda.hhs.gov, 301–796–
6630.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 5,
2010 (75 FR 17093), FDA published a
proposed rule to amend certain
neurological device and physical
medicine device regulations to establish
special controls for these class II devices
and to exempt some of these devices
from the premarket notification
requirements of the Federal Food, Drug,
and Cosmetic Act. Interested persons
were given until July 6, 2010, to
comment on the proposed rule.
erowe on DSK5CLS3C1PROD with PROPOSALS
II. Request for Comments
Following publication of the April 5,
2010, proposed rule, FDA received
requests to allow interested persons
additional time to comment. The
requests asserted that the 90-day time
period was insufficient to respond fully
to FDA’s specific requests for comments
and to allow potential respondents to
thoroughly evaluate and address
pertinent issues. The agency has
considered the requests and is
reopening the comment period until
September 7, 2010. The agency believes
the additional comment period allows
adequate time for interested persons to
submit comments without significantly
delaying rulemaking on these important
issues.
VerDate Mar<15>2010
15:46 Jul 27, 2010
Jkt 220001
III. How to Submit Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m. Monday through Friday.
Dated: July 22, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–18405 Filed 7–27–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
Bureau of Alcohol, Tobacco, Firearms,
and Explosives
27 CFR Part 646
[Docket No. ATF 22P; AG Order No. 3179–
2010]
RIN 1140–AA31
Implementation of the USA PATRIOT
Improvement and Reauthorization Act
of 2005 Regarding Trafficking in
Contraband Cigarettes or Smokeless
Tobacco (2006R–1P)
Bureau of Alcohol, Tobacco,
Firearms, and Explosives (ATF),
Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Department of Justice is
proposing to amend the regulations of
the Bureau of Alcohol, Tobacco,
Firearms, and Explosives (ATF) to
implement certain provisions of the
USA PATRIOT Improvement and
Reauthorization Act of 2005 (enacted
March 9, 2006) relating to trafficking in
contraband cigarettes or smokeless
tobacco. The new law amends the
Contraband Cigarette Trafficking Act by:
reducing the threshold amount of
cigarettes necessary to trigger
jurisdiction under the CCTA from a
quantity in excess of 60,000 to a
quantity in excess of 10,000; extending
the provisions of the CCTA to cover
contraband smokeless tobacco;
imposing reporting requirements on
persons, except tribal governments, who
engage in delivery sales of more than
10,000 cigarettes or 500 single-unit
consumer-sized cans or packages of
smokeless tobacco in a single month;
SUMMARY:
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44173
requiring that cigarettes and smokeless
tobacco seized and forfeited under the
CCTA be either used in law enforcement
operations or destroyed; and by
authorizing state and local governments,
and Federal tobacco permittees to bring
civil causes of action against violators of
the CCTA.
DATES: Written comments must be
postmarked and electronic comments
must be submitted on or before October
26, 2010. Commenters should be aware
that the electronic Federal Docket
Management System will not accept
comments after midnight Eastern Time
on the last day of the comment period.
ADDRESSES: Send comments to any of
the following addresses—
• James P. Ficaretta, Program
Manager, Mailstop 6N–602,
Enforcement Programs and Services,
Bureau of Alcohol, Tobacco, Firearms,
and Explosives, U.S. Department of
Justice, 99 New York Avenue, NE.,
Washington, DC 20226; Attn: ATF 22P.
Written comments must appear in a
minimum 12-point size of type (.17
inches), include your mailing address,
be signed, and may be of any length.
• 202–648–9741 (facsimile).
• https://www.regulations.gov. Federal
eRulemaking portal; follow the
instructions for submitting comments.
You may also view an electronic
version of this proposed rule at the
https://www.regulations.gov site.
Comments may also be submitted
electronically to ATF to https://
www.regulations.gov by using the
electronic comment form provided on
that site. You may also view an
electronic version of this proposed rule
at the https://www.regulations.gov site.
Comments submitted electronically
must contain your name and mailing
address. They must also reference this
document docket number, as noted
above, and be legible when printed on
81⁄2″ x 11″ paper. ATF will treat
comments submitted electronically as
originals and it will not acknowledge
receipt of comments submitted
electronically. Interested parties will not
be able to submit comments
electronically to ATF via https://
www.regulations.gov after the comment
period closes.
See the Public Participation section at
the end of the SUPPLEMENTARY
INFORMATION section for instructions and
requirements for submitting written
comments, and for information on how
to request a public hearing.
FOR FURTHER INFORMATION CONTACT:
James P. Ficaretta; Enforcement
Programs and Services; Bureau of
Alcohol, Tobacco, Firearms, and
Explosives; U.S. Department of Justice;
E:\FR\FM\28JYP1.SGM
28JYP1
]]>Agencies
[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Proposed Rules]
[Pages 44172-44173]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18405]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 890
[Docket No. FDA-2009-N-0493]
RIN 0910-ZA37
Neurological and Physical Medicine Devices; Designation of
Special Controls for Certain Class II Devices and Exemption From
Premarket Notification; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of the comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening until
September 7, 2010, the comment period for the proposed rule published
in the Federal Register of April 5, 2010 (75 FR 17093). The document
proposed to amend certain neurological and physical medicine device
regulations to establish special controls for these class II devices
and to exempt some of these devices from premarket notification
requirements. FDA is reopening the comment period to allow further
comment and to receive any new information.
DATES: Submit electronic or written comments by September 7, 2010.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0493, and/or RIN number 0910-ZA37, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD--ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration,
[[Page 44173]]
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. and Regulatory Information Number (RIN) (if a RIN number
has been assigned) for this rulemaking. All comments received may be
posted without change to https://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading in the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
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 Division of
Dockets Management, 5630 Fishers Lane, rm.1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Robert J. DeLuca, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. G214, Silver Spring, MD 20993-0002,
email: Robert.DeLuca@fda.hhs.gov, 301-796-6630.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 5, 2010 (75 FR 17093), FDA
published a proposed rule to amend certain neurological device and
physical medicine device regulations to establish special controls for
these class II devices and to exempt some of these devices from the
premarket notification requirements of the Federal Food, Drug, and
Cosmetic Act. Interested persons were given until July 6, 2010, to
comment on the proposed rule.
II. Request for Comments
Following publication of the April 5, 2010, proposed rule, FDA
received requests to allow interested persons additional time to
comment. The requests asserted that the 90-day time period was
insufficient to respond fully to FDA's specific requests for comments
and to allow potential respondents to thoroughly evaluate and address
pertinent issues. The agency has considered the requests and is
reopening the comment period until September 7, 2010. The agency
believes the additional comment period allows adequate time for
interested persons to submit comments without significantly delaying
rulemaking on these important issues.
III. How to Submit Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m. Monday through Friday.
Dated: July 22, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-18405 Filed 7-27-10; 8:45 am]
BILLING CODE 4160-01-S
