[Federal Register: September 30, 2010 (Volume 75, Number 189)]
[Notices]
[Page 60463-60464]
[DOCID:fr30se10-89]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0374]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Petition to Request
an Exemption From 100 Percent Identity Testing of Dietary Ingredients:
Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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
November 1, 2010.

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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0608.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

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.

Petition to Request an Exemption From 100 Percent Identity Testing of
Dietary Ingredients: Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements--(OMB Control Number 0910-0608)--Extension

    On October 25, 1994, the Dietary Supplement Health and Education
Act (DSHEA) (Public Law 103-417) was signed into law. DSHEA, among
other things, amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)).
Section 402(g)(2) of the FD&C Act provides, in part, that the Secretary
of Health and Human Services (the Secretary) may, by regulation,
prescribe good manufacturing practices for dietary supplements. Section
402(g)(1) of the FD&C Act states that a dietary supplement is
adulterated if ``it has been prepared, packed, or held under conditions
that do not meet current good manufacturing practice regulations.''
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA may issue
regulations necessary for the efficient enforcement of the FD&C Act.
    FDA published a final rule on June 25, 2007 (72 FR 34752) (the
final rule) that established, in part 111 (21 CFR part 111), the
minimum Current Good Manufacturing Practice (CGMP) necessary for
activities related to manufacturing, packaging, labeling, or holding
dietary supplements to ensure the quality of the dietary supplement. On
June 25, 2007 (72 FR 34959), FDA also published an Interim Final Rule
(the IFR) establishing a procedure for a petition to request an
exemption from 100 percent identity testing of dietary ingredients. The
IFR redesignated Sec.  111.75(a)(1) of the CGMP final rule as Sec.
111.75(a)(1)(i) and set forth a procedure for submission of a petition
to FDA in a new Sec.  111.75(a)(1)(ii), under which manufacturers may
request an exemption from the requirements set forth in Sec.
111.75(a)(1)(i) when the dietary ingredient is obtained from one or
more suppliers identified in the petition. The regulation clarifies
that FDA is willing to consider, on a case-by-case basis, a
manufacturer's conclusion, supported by appropriate data and
information in the petition submission, that it has developed a system
that it would implement as a sound, consistent means of establishing,
with no material diminution of assurance compared to the assurance
provided by 100 percent identity testing, the identity of the dietary
ingredient before use.
    Section 111.75(a)(1) of the CGMP final rule reflects FDA's
determination that manufacturers that test or examine 100 percent of
the incoming dietary ingredients for identity can be assured of the
identity of the ingredient. However, FDA recognizes that it may be
possible for a manufacturer to demonstrate, through various methods and
processes in use over time for its particular operation, that a system
of less than 100 percent identity testing would result in no material
diminution of assurance of the identity of the dietary ingredient as
compared to the assurance provided by 100 percent identity testing. To
provide an opportunity for a manufacturer to make such a showing and
reduce the frequency of identity testing of components that are dietary
ingredients from 100 percent to some lower frequency, FDA added to
Sec.  111.75(a)(1), an exemption from the requirement of 100 percent
identity testing when a manufacturer petitions the agency for such an
exemption to 100 percent identity testing under Sec.  10.30 and the
agency grants such exemption. Such a procedure would be consistent with
FDA's stated goal, as described in the CGMP final rule, of providing
flexibility in the CGMP requirements. Section 111.75(a)(1)(ii) sets
forth the information a manufacturer is required to submit in such a
petition. The regulation also contains a requirement to ensure that the
manufacturer keeps the FDA's response to a petition submitted under
Sec.  111.75(a)(1)(ii) as a record under Sec.  111.95. The collection
of information in Sec.  111.95 has been approved under OMB control
number 0910-0606.
    Description of Respondents: The respondents to this collection of
information are firms in the dietary supplement industry, including
dietary supplement manufacturers, packagers and re-packagers, holders,
labelers and re-labelers, distributors, warehouses, exporters,
importers, large businesses, and small businesses.
    In the Federal Register of July 20, 2010 (75 FR 42095) 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 Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Number of        Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.75(a)(1)(ii)                                                        1                     1                  1                  8                  8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the last 3 years, FDA has not received any new petitions to
request an exemption from 100 percent identity testing of dietary
ingredients; therefore, the agency estimates that one or fewer
petitions will be submitted annually. Although FDA has not received any
new petitions to request an exemption from 100 percent identity testing
of dietary ingredients in the last 3 years, it believes that these
information collection provisions should be extended to provide for the
potential future need of a firm in the dietary supplement industry to
petition for an exemption from 100 percent identity testing of dietary
ingredients. Based on our experience with petition processes, we
estimate that the assembly of information in support of the petition
required by Sec.  111.75(a)(1)(ii) will take 8 hours.

    Dated: September 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24642 Filed 9-29-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: October 11, 2007 (Volume 72, Number 196)]
[Notices]
[Page 57988-57989]
[DOCID:fr11oc07-112]

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DEPARTMENT OF TRANSPORTATION

 Federal Railroad Administration

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System or Relief From the
Requirements of Title 49 Code of Federal Regulations Part 236

    Pursuant to Title 49 Code of Federal Regulations (CFR) Part 235 and
49 U.S.C. 20502(a), the following railroad has petitioned the Federal
Railroad Administration (FRA) seeking approval for the discontinuance
or modification of the signal system or relief from the

requirements of 49 CFR Part 236, as detailed below.

Docket Number FRA-2007-29017

    Applicant: Lake Superior and Ishpeming Railroad Company, Mr. James
Scullion, Manager, Maintenance, P.O. Box 2000, Ishpeming, Michigan
49849.
    The Lake Superior and Ishpeming Railroad Company seeks approval of
the proposed discontinuance and removal of the control points and
associated equipment of a traffic control system (TCS) on the Ore
Subdivision, from Marquette, MI (Milepost 55.27) to East Eagle Mills,
MI (Milepost 64.60), inclusive.
    The reason given for the proposed changes is that the TCS is no
longer necessary for train operations. Main track authority will be
issued through Track Warrant Control.
    Any interested party desiring to protest the granting of an
application, shall set forth specifically the grounds upon which the
protest is made, and include a concise statement of the interest of the
party in the proceeding. Additionally, one copy of the protest shall be
furnished to the applicant at the address listed above.
    FRA expects to be able to determine these matters without an oral
hearing. However, if a specific request for an oral hearing is
accompanied by a showing that the party is unable to adequately present
his/her position by written statements, an application may be set for
public hearing.
    All communications concerning this proceeding should identify the
appropriate docket number (FRA-2007-29017) and may be submitted by one
of the following methods:
    Web site: http://dms.dot.gov. Follow the instructions for

submitting comments on the DOT electronic site;
    Fax:<PHONE_NUMBER>;
    Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590; or
    Hand Delivery: Room W12-140 of the U.S. Department of
Transportation, West Building Ground Floor, 1200 New Jersey Avenue,
SE., Washington, DC between 9 a.m. and 5 p.m. Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA prior to final action being taken. Comments
received after that date will be considered to the extent practicable.
All written communications concerning these proceedings are available
for examination during regular business hours (9 a.m.-5 p.m.) at the
above facility. All documents in the public docket are also available
for inspection and copying on the Internet at the docket facility's Web
site at http://dms.dot.gov.

    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78), or you may visit
http://dms.dot.gov.

    Issued in Washington, DC on October 3, 2007.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E7-19991 Filed 10-10-07; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3673-3674]
[FR Doc No: 2015-01159]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74092; File No. 265-29]

Notice of Federal Advisory Committee Establishment; Equity Market
Structure Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Federal Advisory Committee Establishment.

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SUMMARY: The Securities and Exchange Commission intends to establish
the Securities and Exchange Commission Equity Market Structure Advisory
Committee.

ADDRESSES: Written comments may be submitted by the following methods:

Electronic Comments

     Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
     Send an email message to<EMAIL_ADDRESS>including
File No. 265-29 on the subject line.

Paper Comments

     Send paper comments to Brent J. Fields, Securities and
Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File No. 265-29. To help us process and
review your comments more efficiently, please use only one method. The
Commission will post all comments on the Commission's Internet Web site
(http://www.sec.gov/rules/other.shtml). Comments also will be available
for Web site viewing and printing in the Commission's Public Reference
Room, 100 F Street NE., Washington, DC 20549, on official business days
between the hours of 10:00 a.m. and 3:00 p.m. All comments received
will be posted without change; we do not edit personal identifying
information from your submissions. You should submit only information
that you wish to make available publicly.

FOR FURTHER INFORMATION CONTACT: Arisa Tinaves, Special Counsel,
Securities and Exchange Commission, 100 F Street NE., Washington, DC
20549-3628,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with the requirements of the
Federal Advisory Committee Act, 5 U.S.C.--App., the Commission is
publishing this notice that the Chair of the Commission, with the
concurrence of the other Commissioners, intends to establish the
Securities and Exchange Commission Equity Market Structure Advisory
Committee (the ``Committee''). The Committee's objective is to provide
the Commission with diverse perspectives on the structure and
operations of the U.S. equities markets, as well as advice and
recommendations on matters related to equity market structure.
    No more than seventeen voting members will be appointed to the
Committee. Such members shall represent a cross-section of those
directly affected by, interested in, and/or qualified to provide advice
to the Commission on matters related to equity market structure. The
Committee's membership will be balanced fairly in terms of points of
view represented and functions to be performed.
    The Committee may be established 15 days after publication of this
notice in the Federal Register by filing a charter for the Committee
with the Committee on Banking, Housing, and Urban Affairs of the United
States Senate, the Committee on Financial Services of the

United States House of Representatives, and the Committee Management
Secretariat of the General Services Administration. A copy of the
charter as so filed also will be filed with the Chair of the
Commission, furnished to the Library of Congress, and posted on the
Commission's Web site at www.sec.gov.
    The Committee will operate for two years from the date the charter
is filed with the appropriate entities unless the Commission directs
that the Committee terminate on an earlier date. Prior to the
expiration of this two-year period, the Committee's charter may be re-
established or renewed in accordance with the Federal Advisory
Committee Act.
    The Committee will meet at such intervals as are necessary to carry
out its functions. The charter contemplates that the full Committee
will meet four times annually. Meetings of subgroups or subcommittees
of the full Committee may occur more frequently.
    The charter will provide that the duties of the Committee are to be
solely advisory. The Commission alone will make any determinations of
action to be taken and policy to be expressed with respect to matters
within the Commission's authority as to which the Committee provides
advice or makes recommendations. The Chair of the Commission affirms
that the establishment of the Committee is necessary and in the public
interest.

    Dated: January 20, 2015.

    By the Commission.
Brent J. Fields,
Secretary.
[FR Doc. 2015-01159 Filed 1-22-15; 8:45 am]
BILLING CODE 8011-01-P