[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84462-84463]
[FR Doc No: 2020-28556]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2020-0095]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    Under part 235 of title 49 Code of Federal Regulations (CFR) and 49
U.S.C. 20502(a), this document provides the public notice that on
December 4, 2020, Norfolk Southern Corporation (NS) petitioned the
Federal Railroad Administration (FRA) seeking approval to discontinue
or modify a signal system. FRA assigned the petition Docket Number FRA-
2020-0095.
    Applicant: Norfolk Southern Corporation, T.A. Phillips, Senior
Director--C&S Engineering, 1200 Peachtree Street NE, Atlanta, GA 30309.
    Specifically, NS requests permission to discontinue a traffic
control system (TCS) from milepost (MP) V 327 (PD Junction) to V 381.8
(Maben) on the Princeton-Deepwater line of the Pocahontas Division.
This area includes control points (CPs) at Ambrose, Beggs, Princeton,
Rock, Weyanoke, Clark Gap, Algoquin, Herndon, Alpoca, CP No. 1
Crossover, Elmore, Gulf Junction, Virwest, Maben, and nine automatic
signals. An operative approach signal will be placed at MP V 329.4 in
approach to the CP PD Junction. All slide fences within the application
limits will also be retired. The main track between MP V 327 and MP V
381.8 will be converted to NS Rule 171 operation. The signaled sidings
within the application limits will be made non-controlled, other than
main track.
    NS states that operations in this area no longer require a TCS.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA,

in writing, before the end of the comment period and specify the basis
for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation (DOT), 1200 New Jersey Ave. SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Ave. SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by February 11, 2021 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable. Anyone can search the electronic
form of any written communications and comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the document, if submitted on behalf of an association,
business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its processes. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2020-28556 Filed 12-23-20; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: May 22, 2009 (Volume 74, Number 98)]
[Notices]
[Page 24022]
[DOCID:fr22my09-71]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Food and Drug Administration Clinical Trial Requirements; Public
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) Minneapolis District,
in cosponsorship with the Society of Clinical Research Associates, Inc.
(SoCRA) is announcing a public workshop entitled ``FDA Clinical Trial
Requirements.'' This 2-day public workshop is intended to provide
information about FDA clinical trial requirements to the regulated
industry.
    Date and Time: The public workshop will be held on Wednesday, June
10, 2009, from 8:30 a.m. to 5 p.m., and Thursday, June 11, 2009, from
8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Radisson
University Hotel, Suite 600, 615 Washington Ave., SE., Minneapolis, MN
55414,<PHONE_NUMBER> or 1-800-822-6757 or<PHONE_NUMBER>.
    Contact: Carrie Hoffman, Food and Drug Administration, 250
Marquette Ave., Minneapolis, MN 55401,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>    Attendees are responsible for their own accommodations. To make
reservations at the Radisson University Hotel, contact the Radisson
University Hotel (see Location).
    Registration: You are encouraged to register by June 9, 2009. The
SoCRA registration fees cover the cost of facilities, materials, and
breaks. Seats are limited; please submit your registration as soon as
possible. Course space will be filled in order of receipt of
registration. Those accepted into the course will receive confirmation.
Registration will close after the course is filled. Registration at the
site is not guaranteed but may be possible on a space available basis
on the day of the public workshop beginning at 8 a.m. The cost of
registration is as follows: FDA employee (fee waived), Government
employee nonmember ($525), non-Government employee SoCRA member ($575),
non-Government employee non-SoCRA member ($650).
    If you need special accommodations due to a disability, please
contact Carrie Hoffman (see Contact) at least 7 days in advance of the
workshop.
    Registration Instructions: To register, please submit a
registration form with your name, affiliation, mailing address, phone,
fax number, and e-mail, along with a check or money order payable to
``SoCRA.'' Mail to: SoCRA, 530 West Butler Ave., Suite 109, Chalfont,
PA 18914. To register via the Internet, go to http://www.socra.org/
html/FDA_Conference.htm. (FDA has verified the Web site address, but
we are not responsible for any subsequent changes to the Web site after
this document publishes in the Federal Register.)
    The registrar will also accept payment by major credit cards (VISA/
MasterCard/AMEX only). For more information on the meeting, or for
questions on registration, contact SoCRA at<PHONE_NUMBER> or 215-822-
8644, FAX:<PHONE_NUMBER>, or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the
Department of Health and Human Services' and FDA's important mission to
protect the public health. Topics for discussion include the following:
(1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse
Event Reporting--Science, Regulation, Error and Safety; (3) Part 11
Compliance--Electronic Signatures; (4) Informed Consent Regulations;
(5) IRB Regulations and FDA Inspections; (6) Keeping Informed and
Working Together; (7) FDA Conduct of Clinical Investigator Inspections;
(8) Meetings with FDA: Why, When, and How; (9) Investigator Initiated
Research; (10) Medical Device Aspects of Clinical Research; (11)
Working with FDA's Center for Biologics Evaluation and Research; (12)
The Inspection is Over--What Happens Next? Possible FDA Compliance
Actions.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The workshop helps to achieve objectives set forth
in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393)
which includes working closely with stakeholders and maximizing the
availability and clarity of information to stakeholders and the public.
The workshop also is consistent with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach
activities by Government agencies to small businesses.

    Dated: May 18, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12051 Filed 5-21-09; 8:45 am]

BILLING CODE 4160-01-S


robustness of the study, however adding more housing units or COFs is
not possible due to time and budget constraints.  An increased number of
samples are to be collected in order to overcome some of the limited
variability due to the number of housing units.

2.2.2	Define "a full XRF lead screening inspection."

	Revise the requirement so that the inspection "shall" use the PCS, and
delete the phrase that it is to be used "as a guideline."

Response:

The XRF lead screening inspection will include a measurement on every
unique interior and exterior component of the unit, as well as duplicate
measurements for large components (floors, ceilings, walls, etc.)  We
will follow applicable state regulations, and the PCSs will be followed.

Update table 3-1, and the April 11th date.

Response:

The table has been updated.

Appendices (and corresponding entries in table of contents):

A:	Delete and provide correct citation in main text.  The current
standard is E1729-05 Standard Practice for Field Collection of Dried
Paint Samples for Subsequent Lead Determination; the standard in the
appendix, dated 1999, has expired. Inclusion of the full text here
simply lengthens the document, and there may be a copyright problem if
copying fees have not been paid.

B:	Delete and continue to provide citation in main text.  Inclusion here
simply lengthens the document.

D:	Delete and continue to provide citation in main text.  Inclusion here
simply lengthens the document.

Note that deleting the cited photocopied pages in the appendices will
shorten the design document by about three-quarters, a significant
benefit.

Response:

While these sections could be replaced by a shorter protocol attuned to
the study needs – having this documentation available within the QAPP
for the field supervisor and others performing the study is often
helpful for ensuring that all of the study protocols are  followed
appropriately.

 HUD [1985]. Guidelines for the evaluation and control of lead-based
paint hazards in housing. Washington DC: U.S. Department of Housing and
Urban Development, Office of Lead Hazard Control.

 NIOSH [2002]. Hazard evaluation and technical assistance report: Lead
Safe Services, Inc., Neenah, Wisconsin. Cincinnati, OH: U.S. Department
of Health and Human Services, Centers for Disease Control and
Prevention, National Institute for Occupational Safety and Health, NIOSH
Report No. HETA 99-0305-2878.

Page   PAGE  59  of 59

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[Federal Register Volume 84, Number 135 (Monday, July 15, 2019)]
[Notices]
[Pages 33808-33810]
[FR Doc No: 2019-14976]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0315]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to renew exemptions for three
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on May 5, 2019. The exemptions
expire on May 5, 2021. Comments must be received on or before received
on or before August 14, 2019.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2016-0315 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2016-0315), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.

    To submit your comment online, go to http://www.regulations.gov,
put the docket number, FMCSA-2016-0315, in the keyword box, and click
``Search.'' When the new screen appears, click on the ``Comment Now!''
button and type your comment into the text box on the following screen.
Choose whether you are submitting your comment as an individual or on
behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2016-0315, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for up to five years if it finds such exemption would likely achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption. The statute also allows the
Agency to renew exemptions at the end of the five-year period. FMCSA
grants exemptions from the FMCSRs for a two-year period to align with
the maximum duration of a driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
    The three individuals listed in this notice have requested renewal
of their exemptions from the epilepsy and seizure disorders prohibition
in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures.
Accordingly, FMCSA has evaluated these applications for renewal on
their merits and decided to extend each exemption for a renewable two-
year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315, each of the three
applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The
three drivers in this notice remain in good standing with the Agency,
have maintained their medical monitoring and have not exhibited any
medical issues that would compromise their ability to safely operate a
CMV during the previous two-year exemption period. In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License Information System (CDLIS) and the Motor Carrier Management
Information System (MCMIS) are searched for crash and violation data.
For non-CDL holders, the Agency reviews the driving records from the
State Driver's Licensing Agency (SDLA). These factors provide an
adequate basis for predicting each driver's ability to continue to
safely operate a CMV in interstate commerce. Therefore, FMCSA concludes
that extending the exemption for each renewal applicant for a period of
two years is likely to achieve a level of safety equal to that existing
without the exemption.
    As of May 5, 2019, and in accordance with 49 U.S.C. 31136(e) and
31315, the following three individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers: Brian
Brown (PA); Adam Cutler (MA); and Larry Henington (UT).
    The drivers were included in docket number FMCSA-2016-0315. Their
exemptions are applicable as of May 5, 2019, and will expire on May 5,
2021.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the two-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each
driver must provide a copy of the annual medical certification to the
employer for retention in the driver's qualification file, or keep a
copy of his/her driver's qualification file if he/she is self-employed.
The driver must also have a copy of the exemption when driving, for
presentation to a duly authorized Federal, State, or local enforcement
official. The exemption will be rescinded if: (1) The person fails to
comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based on its evaluation of the three exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the epilepsy
and seizure

disorders prohibition in 49 CFR 391.41(b)(8). In accordance with 49
U.S.C. 31136(e) and 31315, each exemption will be valid for two years
unless revoked earlier by FMCSA.

    Issued on: July 5, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-14976 Filed 7-12-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44616-44626]
[FR Doc No: 2016-16176]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1206]

Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Ebola Zaire Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for detection of the Ebola Zaire
virus in response to the Ebola virus outbreak in West Africa. FDA
issued this Authorization under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by Biocartis NV. The Authorization
contains, among other things, conditions on the emergency use of the
authorized in vitro diagnostic device. The Authorization follows the
September 22, 2006, determination by then-Secretary of the Department
of Homeland Security (DHS), Michael Chertoff, that the Ebola virus
presents a material threat against the U.S. population sufficient to
affect national security. On the basis of such determination, the
Secretary of Health

and Human Services (HHS) declared on August 5, 2014, that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostic devices for detection of Ebola virus, subject to the terms
of any authorization issued under the FD&C Act. The Authorization,
which includes an explanation of the reasons for issuance, is reprinted
in this document.

DATES: The Authorization is effective as of May 26, 2016.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) a determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves a
biological, chemical, radiological, or nuclear agent or agents, or a
disease or condition that may be attributable to such agent or agents;
or (4) the identification of a material threat by the Secretary of
Homeland Security under section 319F-2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \1\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) The product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; and (4)
that such other criteria as may be prescribed by regulation are
satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Request for an In Vitro Diagnostic Device for Detection of the
Ebola Zaire Virus

    On September 22, 2006, then-Secretary of DHS, Michael Chertoff,
determined that the Ebola virus presents a material threat against the
U.S. population sufficient to affect national security \2\. On August
5, 2014, under section 564(b)(1) of the FD&C Act and on the basis of
such determination, the Secretary of HHS declared that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostic devices for detection of Ebola virus, subject to the terms
of any authorization issued under section 564 of the FD&C Act. Notice
of the declaration of the Secretary was published in the Federal
Register on

August 12, 2014 (79 FR 47141). On May 2, 2016, Biocartis NV submitted a
complete request for, and on May 26, 2016, FDA issued, an EUA for the
IdyllaTM Ebola Virus Triage Test, subject to the terms of
the Authorization.
---------------------------------------------------------------------------

    \2\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's
declaration that supports the EUA issuance must be based on one of
four determinations, including the identification by the DHS
Secretary of a material threat under section 319F-2 of the PHS Act
sufficient to affect national security or the health and security of
U.S. citizens living abroad (section 564(b)(1)(D) of the FD&C Act.
---------------------------------------------------------------------------

III. Electronic Access

    An electronic version of this document and the full text of the
Authorization are available on the Internet at http://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of an in vitro diagnostic device for
detection of Ebola Zaire virus (detected in the West Africa outbreak in
2014) subject to the terms of the Authorization. The Authorization in
its entirety (not including the authorized versions of the fact sheets
and other written materials) follows and provides an explanation of the
reasons for its issuance, as required by section 564(h)(1) of the FD&C
Act:
BILLING CODE 4164-01-P

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    Dated: July 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16176 Filed 7-7-16; 8:45 am]
 BILLING CODE 4164-01-C


[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Notices]
[Pages 53486-53489]
[FR Doc No: 2016-19306]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0376]

Dietary Supplements: New Dietary Ingredient Notifications and
Related Issues; Revised Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
issuance of a revised draft guidance for industry entitled ``Dietary
Supplements: New Dietary Ingredient Notifications and Related Issues.''
The revised draft guidance supersedes FDA's July 2011 draft guidance on
the same topic. The revised draft guidance, when finalized, will help
industry in evaluating whether to submit a premarket safety
notification for a new dietary ingredient (NDI), or for a dietary
supplement containing an NDI, and in preparing such premarket safety
notifications (also referred to as NDI notifications).

DATES: Although you may comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that FDA considers your comment on the draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by
October 11, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2011-D-0376 for ``Dietary Supplements: New Dietary Ingredient
Notifications and Related Issues; Revised Draft Guidance for
Industry.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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 except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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.
    Submit written requests for single copies of the draft guidance to
the Division of Dietary Supplement Programs, Center for Food Safety and
Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus
Drive, College Park, MD 20740. Send one self-addressed adhesive label
to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance.

FOR FURTHER INFORMATION CONTACT: Ali Abdel-Rahman, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a revised draft guidance for
industry entitled ``Dietary Supplements: New Dietary Ingredient
Notifications and Related Issues.'' This draft guidance supersedes the
July 2011 draft guidance on this topic (76 FR 39111; July 5, 2011) and
is being issued consistent with our good guidance practices regulation
(21 CFR 10.115). The draft guidance, when finalized, will represent our
current thinking on this topic. It will not create or confer any rights
for or on any person and will not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
    On October 25, 1994, the Dietary Supplement Health and Education
Act of 1994 (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by
adding, among other provisions: (1) Section 201(ff) (21 U.S.C.
321(ff)), which defines the term ``dietary supplement'' and (2) section
413 (21 U.S.C. 350b), which describes requirements for NDIs. Among
other things, section 413 of the FD&C Act requires the manufacturer or
distributor of an NDI, or of a dietary supplement containing the NDI,
to submit a premarket notification to FDA (as delegate for the
Secretary of Health and Human Services) at least 75 days before
introducing the NDI or dietary supplement into interstate commerce,
unless the NDI and any other ingredients in the dietary supplement have
been present in the food supply as an article used for food in a form
in which the food has not been chemically altered (21 U.S.C.
350b(a)(1)). The notification must contain the information, including
any citation to published articles, which is the manufacturer or
distributor's basis for concluding that a dietary supplement containing
the NDI will reasonably be expected to be safe.
    This draft guidance has several purposes. First, it is intended to
help dietary supplement manufacturers and distributors decide whether
to submit an NDI notification. In addition, the draft guidance is
intended to provide recommendations on how to conduct a safety
assessment for an NDI notification and what to include in the
notification. In question and answer form, the draft guidance presents
FDA's views on what qualifies as an NDI; when an NDI notification is
required; the procedures for submitting an NDI notification; the types
of data and information that manufacturers and distributors should
consider when evaluating the safety of a dietary supplement containing
an NDI; and what should be included in an NDI notification. In
addition, the draft guidance contains questions and answers about parts
of the dietary supplement definition (section 201(ff) of the FD&C Act)
that can affect whether a particular substance may be marketed as a
dietary ingredient in a dietary supplement.
    We issued the original version of this draft guidance in the
Federal Register of July 5, 2011 (the 2011 draft guidance). We gave
interested parties an opportunity to submit comments by October 3,
2011. In the Federal Register of September 9, 2011 (76 FR 55927), we
extended the comment period to December 2, 2011. We received numerous
comments on the 2011 draft guidance.
    Based on those comments and on meetings with industry and other
stakeholders, we realized that the 2011 draft guidance contained gaps
and unclear statements that were subject to confusion and
misinterpretation. Therefore, we decided to clarify and better explain
our thinking on some critical issues, in addition to explaining their
public health significance, and to

request additional comments on these issues before publishing a final
guidance. We have revised certain questions and answers and added a
number of new questions and answers.
    The major topics on which we have revised or added questions and
answers are as follows:
     Chemical alteration--Dietary supplements containing an NDI
are exempt from the notification requirement when they contain only
dietary ingredients that have been present in the food supply as an
article used for food in a form in which the food has not been
chemically altered. Section IV.B of the revised draft guidance explains
FDA's interpretation of ``present in the food supply as an article used
for food'' and the public health basis for that interpretation. In
addition, section IV.B has been revised to address the question of what
constitutes ``chemical alteration'' more fully and to explain FDA's
reasoning on this issue, as well as discussing additional examples of
when chemical alteration occurs and when it does not. Because no
guidance document can cover every possible manufacturing scenario, the
draft guidance encourages industry to consult with FDA in advance on
such matters.
     Manufacturing changes that create an NDI--A related issue
addressed in section IV.A of the draft guidance is when a manufacturing
change alters the structure or properties of an ingredient and creates
an NDI for which a notification must be submitted. The revised draft
guidance provides examples of manufacturing changes that alter the
identity of the ingredient, the key factor in determining whether they
also change the regulatory status of the ingredient.
     Synthetic substances--Section IV.D of the revised draft
guidance contains an expanded discussion clarifying FDA's views on when
synthetic copies of botanical and other dietary ingredients qualify as
dietary ingredients under the FD&C Act. FDA's thinking is based on the
text of section 201(ff)(1) of the FD&C Act, which defines some types of
dietary ingredients by identity and others by function.
     New dietary ingredient definition and list of
``grandfathered'' dietary ingredients--In section IV.A of the draft
guidance, we revised our response to the question about whether there
is an authoritative list of dietary ingredients marketed before October
15, 1994 (a so-called ``grandfathered list'' or ``old dietary
ingredient list''). Dietary ingredients marketed before that date are
not NDIs and therefore are not subject to the premarket notification
requirement in section 413 of the FD&C Act. Although there is currently
no authoritative list of ``grandfathered'' ingredients, the revised
answer notes that FDA is prepared to compile such a list based on
independent and verifiable data to be submitted by industry. The
revised answer also discusses FDA's thinking on the regulatory status
of dietary ingredients that would be on such a list, as well as the
status of dietary ingredients not on such a list.
    We also revised several questions and answers in section IV.A to
clarify various matters regarding FDA's interpretation of the terms
``marketed'' and ``dietary ingredient'' in section 413(d) of the FD&C
Act, which defines an NDI as a dietary ingredient that was not marketed
in the United States before October 15, 1994, and we added more
examples of documentation that can be used to show that a dietary
ingredient was marketed prior to October 15, 1994.
     Structuring notifications efficiently and relying on data
from prior notifications and master files--We added several questions
and answers in section IV.C of this draft guidance to suggest ways
manufacturers and distributors can reduce the number of NDI
notifications they must file and to clarify when data and information
from a previous notification or ``master file'' may be used in a
notification. For example, the answer to a new question clarifies that
firms may submit an NDI notification that covers the use of the NDI in
multiple dietary supplements and includes safety data for a range of
doses and/or differing conditions of use. This answer also explains
that a firm may submit a confidential ``master file'' containing
specifications, manufacturing procedures, and other identity
information for an NDI, and may incorporate information from the master
file into its own NDI notification or may authorize another firm to
rely on information from the master file in a notification for a
dietary supplement containing the NDI. We also added a question and
answer to describe when a firm may rely on data in another
notification. In addition, section IV.C now includes a question and
answer with six examples distinguishing situations in which separate
notifications are required for different dietary supplements containing
the same NDI from situations in which a single NDI notification covers
multiple dietary supplements containing the same NDI. Finally, section
IV.C now clarifies that, although a combination of NDIs is itself an
NDI, a combination of grandfathered dietary ingredients is not, even if
that combination has not been used in a dietary supplement before.
     Identity information to include in an NDI notification--We
revised several questions and answers in section VI.A in consideration
of comments regarding chemical and botanical information necessary to
determine the identity of an NDI. We also added a new question and
answer with recommendations about what chemistry information should be
included in a notification for an enzyme NDI. In addition, since some
of the standard references on nomenclature of plants and microorganisms
have been renamed or updated since the 2011 draft guidance, we updated
the citations to refer to the most recent edition.
     Electronic submission--We updated the question and answer
in section V.A about electronic submission of NDI notifications. The
updated answer states that we are accepting NDI notifications
electronically and provides the Internet address for the electronic
submission gateway. As before, the answer notes that firms still have
the option to submit paper notifications to FDA using the procedure
described in 21 CFR 190.6.
     PDF form for NDI notifications submitted on paper--Because
our electronic submission gateway for NDI notifications is now
available, we have decided not to provide a competing form for paper
notifications. Therefore, we have removed ``Appendix B: 75-Day Pre-
Market New Dietary Ingredient Notification Form'' from the draft
guidance.
     Safety information to include in an NDI notification--We
revised several questions and answers in sections VI.B and VI.C to
clarify our thinking on compiling and evaluating scientific evidence
about the safety of NDIs and dietary supplements that contain NDIs. In
section VI.B, we clarified our thinking on the use of foreign history
of use data. We also added a recommendation to consult ``Principles and
Methods for the Risk Assessment of Chemicals in Food,'' a joint
publication of the World Health Organization and the Food and
Agriculture Organization of the United Nations, as a useful source of
information on conducting human clinical studies for NDIs and dietary
supplements. In response to comments, we removed all references to
FDA's ``Redbook'' guidance, which contains recommendations on toxicity
studies and other scientific evidence needed to determine the safety of
food additives. We also revised section VI.B to explain that the NDI
safety standard is different from the standards for other FDA-regulated
products and clarify that evidence for an NDI safety evaluation should
be compiled to meet that standard. Although the revised draft

guidance no longer cites the Redbook, we continue to recommend the use
of the dietary exposure assessment methodology and some toxicology
tests that are also used for the evaluation of food additives because
these are standard scientific methods not specific to any particular
safety assessment paradigm. Finally, we added a new question at the end
of section VI.C to emphasize that this draft guidance contains
recommendations about safety information to include in an NDI
notification, but these recommendations are not requirements.
     Other changes--We made clarifying changes, explanatory
changes, and editorial changes throughout the document. We also updated
references and links and added new references where appropriate.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. This draft guidance contains proposed collections
of information. ``Collection of information'' is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish a
60-day notice in the Federal Register soliciting public comment on each
proposed collection of information before submitting the collection to
OMB for approval. To comply with this requirement, we intend to publish
a 60-day notice on the proposed collections of information in this
draft guidance in a future issue of the Federal Register.
    This 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 111 have been approved under OMB control
number 0901-0606, and the collections of information in Sec.  190.6
have been approved under OMB control number 0910-0330.

III. Other Issues for Consideration

    Although FDA welcomes comments on any aspect of this draft
guidance, we particularly invite comment on the following:
     What processes alter the identity of an ingredient
marketed prior to October 15, 1994, and thus create an NDI? We are
especially interested in recommendations for clearer examples or
criteria to differentiate changes in manufacturing methods and starting
materials that alter the identity of the ingredient from changes that
do not.
     What processes ``chemically alter'' an ingredient within
the meaning of section 413(a)(1) of the FD&C Act, and why? Conversely,
what processes do not cause chemical alteration, and why? Are there
certain processes, such as tinctures, that sometimes result in chemical
alteration and sometimes do not? What criteria should be used to
evaluate whether an ingredient has been chemically altered? We are
especially interested in receiving scientific information that shows
whether a particular process actually results in chemical alteration.
     What method of compiling independent and verifiable data
on the marketing of dietary ingredients before October 15, 1994, would
be most effective? How should an authoritative list of
``grandfathered'' ingredients based on such data be developed and
implemented?
    As FDA considers the development of final guidance, we will review
comments received on this revised version, as well as comments on the
2011 draft guidance that are still relevant.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the draft guidance.

V. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. International Programme on Chemical Safety, ``Principles and
Methods for the Risk Assessment of Chemicals in Food,''
Environmental Health Criteria 240 (2009), available at: http://www.who.int/foodsafety/publications/chemical-food/en/.
2. The official name of the Redbook is ``Guidance for Industry and
Other Stakeholders: Toxicological Principles for the Safety
Assessment of Food Ingredients,'' available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2006826.htm.

    Dated: August 9, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19306 Filed 8-11-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 2, 2010 (Volume 75, Number 105)]
[Notices]
[Page 30808-30810]
[DOCID:fr02jn10-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

May 25, 2010.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC10-73-000.
    Applicants: KGEN Sandersville LLC.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities and Request for Expedited Action of KGen
Sandersville LLC.
    Filed Date: 05/24/2010.
    Accession Number: 20100524-5078.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-794-002.
    Applicants: Entergy Services, Inc.
    Description: Entergy Services, Inc submits clean copy of the sub,
Entergy open access transmission tariff sheets.
    Filed Date: 05/24/2010.
    Accession Number: 20100525-0203.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.

    Docket Numbers: ER10-892-000; ER10-892-001.
    Applicants: Southern Turner Cimarron I, LLC.
    Description: Amendment to Application of Southern Turner Cimarron
LLC.
    Filed Date: 05/20/2010.
    Accession Number: 20100520-5128.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 3, 2010.

    Docket Numbers: ER10-1297-000.
    Applicants: Tampa Electric Company.
    Description: Filing by Tampa Electric Company of Service Agreement
under cost-based power sales tariff re Tampa Electric Company.
    Filed Date: 05/21/2010.
    Accession Number: 20100524-0209.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1298-000.
    Applicants: Southwestern Electric Power Company.
    Description: Southwestern Electric Power Company submits Commission
review actuarial reports with respect to actual post-employment
benefits etc.
    Filed Date: 05/24/2010.
    Accession Number: 20100524-0215.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.

    Docket Numbers: ER10-1299-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits the Interconnection and
Balancing Area Services Agreement with Midwest Energy, Inc to be
effective 6/1/10.
    Filed Date: 05/24/2010.
    Accession Number: 20100524-0214.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.

    Docket Numbers: ER10-1300-000.
    Applicants: Southwest Power Pool Inc.
    Description: Southwest Power Pool, Inc submits Third Revised Sheet
186 et al. to FERC Electric Tariff, Fifth Revised Volume 1 to be
effective 6/23/10.
    Filed Date: 05/24/2010.
    Accession Number: 20100524-0213.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.

    Docket Numbers: ER10-1301-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits Notice of Cancellation of the Adjacent Balancing Authority
Coordination Agreement.
    Filed Date: 05/24/2010.
    Accession Number: 20100525-0202.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.

    Docket Numbers: ER10-1302-000.
    Applicants: Central Hudson Gas & Electric Corporation.
    Description: Central Hudson Gas & Electric Corporation submits
filing to cancel its Open Access Transmission Tariff, FERC Electric
Tariff, Original Volume 2.
    Filed Date: 05/24/2010.
    Accession Number: 20100525-0204.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.

    Docket Numbers: ER10-1303-000.
    Applicants: Genesee Power Station Limited Partnership.
    Description: Genesee Power Station Limited Partnership submits
tariff filing per 35.12: Genesee Power Station LP FERC Schedule No 1
Electric Tariff to be effective 5/26/2010.
    Filed Date: 05/25/2010.
    Accession Number: 20100525-5018
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 15, 2010.

    Docket Numbers: ER10-1304-000.
    Applicants: DownEast Power Company, LLC.
    Description: DownEast Power Company, LLC submits tariff filing per
35.12: Baseline eTariff Filing Pursuant to Order No. 714 to be
effective 6/1/2009.
    Filed Date: 05/25/2010.
    Accession Number: 20100525-5033.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 15, 2010.
    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES10-45-000.
    Applicants: MDU Resources Group, Inc.
    Description: Application of MDU Resources Group, Inc. for authority
to Issue.
    Filed Date: 05/24/2010.
    Accession Number: 20100524-5141.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or

call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-13171 Filed 6-1-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 137 (Wednesday, July 19, 2017)]
[Notices]
[Pages 33101-33102]
[FR Doc No: 2017-15090]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2197-117]

Cube Yadkin Generation, LLC; Notice of Application Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Shoreline Management Plan--Updated Guidelines.
    b. Project No: 2197-117.
    c. Date Filed: May 12, 2017.
    d. Applicant: Cube Yadkin Generation, LLC.
    e. Name of Project: Yadkin Hydroelectric Project.
    f. Location: The Yadkin and Pee Dee rivers in Stanly, Davidson,
Montgomery, Rowan, and Davie counties, North Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mark Gross, Cube Hydro Carolinas, LLC, 293
Highway 740, Badin, NC 28009-0575,<PHONE_NUMBER>.
    i. FERC Contact: Mark Carter,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: August 11, 2017.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888

First Street NE., Washington, DC 20426. The first page of any filing
should include docket number P-2197-117. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee filed for Commission
approval revised appendices to its approved shoreline management plan
pursuant to Article 407 of the license. The revised appendices (i.e.,
Appendix E--Specifications for Private Recreation Facilities, Appendix
F--Subdivision Access Approval Procedures, and Appendix G--Shoreline
Stewardship Policy) were filed during the re-licensing process,
discussed in Commission staff's Final Environmental Impact Statement
for the project, but not approved under the new license. The revised
appendices would increase flexibility in dock design, allow additional
lands adjacent to the project to pursue dock permits, make changes to
vegetation removal procedures, etc.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title COMMENTS, PROTEST, or MOTION TO INTERVENE as
applicable; (2) set forth in the heading the name of the applicant and
the project number of the application to which the filing responds; (3)
furnish the name, address, and telephone number of the person
commenting, protesting or intervening; and (4) otherwise comply with
the requirements of 18 CFR 385.2001 through 385.2005. All comments,
motions to intervene, or protests must set forth their evidentiary
basis. Any filing made by an intervenor must be accompanied by proof of
service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 385.2010.

    Dated: July 12, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-15090 Filed 7-18-17; 8:45 am]
 BILLING CODE 6717-01-P


John Durkee call<PHONE_NUMBER>

5/31/2007

BCBTF exposure limit  25 ppm  VOC exempt

Trying to position one the other

What ODP?

II-D-116 in docket—can look it up

No specific use condition on PCBTF?  Yes.


[Federal Register Volume 87, Number 150 (Friday, August 5, 2022)]
[Rules and Regulations]
[Pages 47935-47937]
[FR Doc No: 2022-16802]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0530]
RIN 1625-AA00

Safety Zone; Port Huron Float Down, St. Clair River, Port Huron,
MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the St. Clair River in the vicinity of Port Huron,
MI. This zone is intended to restrict and control movement of vessels
in a portion of the St. Clair River. Though this is an unsanctioned,
non-permitted marine event, this zone is necessary to provide for the
safety of life on the navigable waters during a float down event near
Port Huron, MI.

DATES: This rule is effective from 12 p.m. through 8 p.m. on August 21,
2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0530 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Ms. Tracy Girard, U.S. Coast Guard;<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    During the afternoon of August 21, 2022, a non-sanctioned public
event is scheduled to take place. The event is advertised over various
social-media sites, in which a large number of persons float down a
segment of the St. Clair River, using inner tubes and other similar
floatation devices. The 2022 float down event will occur from
approximately 12 noon through 8 p.m. on August 21, 2022. This non-
sanctioned event has taken place on the third Sunday in August annually
since 2009.
    No private or municipal entity requested a marine event permit from
the Coast Guard for this event, and it has not received state or
federal permits since its inception. The event has drawn over 5,000
participants of various ages annually. Despite plans put together by
federal, state and local officials, emergency responders and law
enforcement officials have been overburdened pursuing safety during
this event. Medical emergencies, people drifting across the
international border, and people trespassing on residential property
when trying to get out of the water before the designated finish line
are some of the numerous difficulties encountered during the float down
event.
    During the 2014 float-down event, a 19-year-old participant died.
During the 2016 float down, a wind shift caused thousands of U.S.
citizen rafters with no passports to drift into Canadian waters. The
current and wind made it impossible for the rafters to paddle back into
U.S. waters, necessitating significant coordination with the Canadian
authorities. Despite these events, promotional information for the
event continues to be published. More than 5,000 people are again
anticipated to float down the river this year. No public or private
organization holds themselves responsible as the event sponsor.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so is impracticable. The
organizers of this event are very secretive, and careful not to be
found out as the event has ``no sponsor.'' The Coast Guard could not
receive notice of the float down with sufficient time to undergo notice
and comment because the date of the event varies from year to year. The
Coast Guard was not made aware the float down would occur in 2022 until
there was insufficient time to allow for a comment period to run. We
must establish this safety zone by August 21, 2022 in order to protect
the public form the hazards listed above associated with the float
down.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Detroit
(COTP) has determined the float down poses significant risk to public
safety and property from 12 noon through 8 p.m. on August 21, 2022. The
likely combination of large numbers of participants, strong river
currents, limited rescue resources, and difficult emergency response
scenarios could easily result in serious injuries or fatalities to
float down participants and spectators. Therefore, the COTP is
establishing a safety zone around the event location to help minimize
risks to safety of life and property during this event.

IV. Discussion of the Rule

    This rule establishes a safety zone from 12 noon through 8 p.m. on
August 21, 2022. The safety zone will begin at Lighthouse Beach and
encompass all U.S. waters of the St. Clair River bound by a line
starting at a point on land north of Coast Guard Station Port Huron at
position 43[deg]00.416' N; 082[deg]25.333' W, extending east to the
international boundary to a point at position 43[deg]00.416' N;
082[deg]25.033' W, following south along the international boundary to
a point at position 42[deg]54.500' N; 082[deg]27.683' W, extending west
to a point on land just north of Stag Island at position 42[deg]54.500'
N; 082[deg]27.966' W, and following north along the U.S. shoreline to
the point of origin (WGS 84). No vessel or person will be permitted to
enter the safety zone without obtaining permission from the COTP or a
designated representative. Vessel operators must contact the COTP or
his or her on-scene representative to obtain permission to transit
through this safety zone. Additionally, no one under the age of 18 will
be permitted to enter the safety zone if they are not wearing a Coast
Guard approved personal floatation device. The COTP or his or her on-
scene representative may be contacted via VHF Channel 16.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and

Executive orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
will not able to safely transit around this safety zone which will
impact a designated area of the St. Clair River for 8 hours. Moreover,
the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM
marine channel 16 about the zone, and the rule would allow vessels to
seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting 8 hours that will prohibit entry to a designated
portion of the St. Clair River is categorically excluded from further
review under paragraph L[60] of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165: REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1,
Revision No. 01.2.

0
2. Add Sec.  165.T09-0530 to read as follows:

Sec.  165.T09-0530  Safety Zones; Port Huron Float Down, St. Clair
River, Port Huron, MI.

    (a) Location. A safety zone is established to include all U.S.
navigable waters of southern Lake Huron and the St. Clair River
adjacent to Port Huron, MI, beginning at Lighthouse Beach and
encompassing all U.S. waters of the St. Clair River bound by a line
starting at a point on land north of Coast Guard Station Port Huron at
position 43[deg]00.416' N; 082[deg]25.333' W, extending east to the
international boundary to a point at position 43[deg]00.416' N;
082[deg]25.033' W, following south along the international boundary to
a point at

position 42[deg]54.500' N; 082[deg]27.683' W, extending west to a point
on land just north of Stag Island at position 42[deg]54.500' N;
082[deg]27.966' W, and following north along the U.S. shoreline to the
point of origin (NAD 83). (WGS 84).
    (b) Enforcement period. The safety zone described in paragraph (a)
will be enforced from 12 p.m. through 8 p.m. on August 21, 2022.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into, transiting, or anchoring within these safety
zones is prohibited unless authorized by the COTP Detroit or a
designated on-scene representative.
    (2) The safety zones are closed to all vessel traffic, except as
may be permitted by the COTP Detroit or a designated on-scene
representative.
    (3) The ``on-scene representative'' of the COTP Detroit is any
Coast Guard commissioned, warrant or petty officer or a federal, state,
or local law enforcement officer designated by the COTP Detroit to act
on his behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zones must contact the COTP Detroit or an on-scene representative to
obtain permission to do so. The COTP Detroit or an on-scene
representative may be contacted via VHF Channel 16. Vessel operators
given permission to enter or operate in the safety zone must comply
with all directions given to them by the COTP Detroit or an on-scene
representative.

    Dated: August 1, 2022.
Brad W. Kelly,
Commander, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2022-16802 Filed 8-4-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37058-37059]
[FR Doc No: 2012-15025]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2012-D-0304]

Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Implanted Blood
Access Devices for Hemodialysis; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Implanted Blood Access Devices for Hemodialysis.''
This draft guidance document describes a means by which implanted blood
access devices may comply with the requirement of special controls for
class II devices. This draft guidance is not final nor is it in effect
at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 18, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance
Document: Implanted Blood Access Devices for Hemodialysis'' to the
Division of Small Manufacturers, International and Consumer Assistance,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1646, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

I. Background

    This draft guidance document was developed as a special control
guidance to support the reclassification of implanted blood access
devices into class II (special controls). This draft guidance document
will serve as the special control for implanted blood access devices.
Section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) provides that the Agency may initiate the reclassification of a
device. This classification will be a reclassification of the device.
FDA must publish a notice in the Federal Register announcing this
reclassification. Elsewhere in this issue of the Federal Register, FDA
is publishing a proposed rule to reclassify this device type from class
III into class II (special controls), under section 513(e) of the FD&C
Act (21 U.S.C. 360c(e)).
    FDA is issuing this guidance document as a level 1 draft guidance
document. FDA will consider any comments that are received within 90
days of the issuance of this notice to determine whether to revise the
guidance document.

II. Significance of Special Controls Guidance Document

    FDA believes that adherence to the recommendations described in
this draft guidance document, when finalized, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of implanted blood access devices classified under Sec.
876.5540(b)(1) (21 CFR 876.5540(b)(1)). If classified as a class II
device under Sec.  876.5540(b)(1), implanted blood access devices will
need to comply with the requirement for special controls; manufacturers
will need to address the issues requiring special controls as
identified in the guidance document or by some other means that
provides equivalent assurances of safety and effectiveness.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Class II Special Controls Guidance Document: Implanted Blood Access
Devices for Hemodialysis,'' you may either send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive

a hard copy. Please use the document number 1781 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E are currently
approved under OMB control number 0910-0120; the collections of
information in 21 CFR 56.115 are currently approved under OMB control
number 0910-0130; the collections of information in 21 CFR part 812 are
currently approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 801 are currently approved
under OMB control number 0910-0485.

V. 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: June 15, 2012.
Nancy K. Stade,
 Deputy Director for Policy, Center for Devices and Radiological
Health.
[FR Doc. 2012-15025 Filed 6-19-12; 8:45 am]
BILLING CODE 4160-01-P