[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43383-43384]
[FR Doc No: 2017-19614]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4792]

Regulatory Considerations for Microneedling Devices; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Regulatory
Considerations for Microneedling Devices--Draft Guidance for Industry
and Food and Drug Administration Staff.'' This draft guidance is being
issued to assist industry in understanding when a microneedling product
is a device as defined in the Federal Food, Drug, and Cosmetic Act (the
FD&C Act). This draft guidance is not final nor is it in effect at this
time.

DATES: Submit either electronic or written comments on the draft
guidance by November 14, 2017 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2017-D-4792 for ``Regulatory Considerations for Microneedling
Devices--Draft Guidance for Industry and Food and Drug Administration
Staff.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). An electronic copy of the guidance document is available
for download from the internet. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance. Submit
written requests for a single hard copy of the draft guidance document
entitled ``Regulatory Considerations for Microneedling Devices--Draft
Guidance for Industry and Food and Drug Administration Staff'' to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Peter Yang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1551, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    ``Microneedling products'' is a generic term that encompasses
instruments with common technological features that include an array of
needles, ``micro-protrusion'' tips, or pins, which can be

blunt or sharp, and of varying lengths. This document discusses when
microneedling products are devices as defined under section 201(h) of
the FD&C Act (21 U.S.C. 321(h)). This draft guidance also provides
clarity on the regulatory pathway to market for microneedling devices,
resulting in more transparency and predictability to firms and
stakeholders, which may translate into more efficient device
development and patient access to such devices. The scope of this
guidance document does not include microneedling combination products,
acupuncture needles, hypodermic needles or other needles for injection,
tattoo machine needles, and needle probes that emit any type of energy
(e.g., radiofrequency needles) or deliver any type of energy to a
patient (e.g., LASER, ultrasound).

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Regulatory
Considerations for Microneedling Devices--Draft Guidance for Industry
and Food and Drug Administration Staff'' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1500036 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously 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, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120, and the collections of information in 21 CFR
part 801, regarding device labeling, have been approved under OMB
control number 0910-0485.

    Dated: September 7, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19614 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 11, 2011 (Volume 76, Number 7)]
[Notices]
[Page 1613]
[DOCID:fr11ja11-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Change in Time of Commission Meeting

January 4, 2011.
    The Commission's open meeting scheduled for Thursday, January 20,
2011, will begin at 9 a.m.

Kimberly D. Bose,
Secretary.
[FR Doc. 2011-300 Filed 1-10-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52165-52166]
[FR Doc No: 2019-21279]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2008-0355; FMCSA-2011-0089; FMCSA-2014-0381; FMCSA-
2014-0382]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for four
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 July 12, 2019. The exemptions
expire on July 12, 2021.

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 Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. 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-2008-0355; FMCSA-2011-0089; FMCSA-2014-
0381; FMCSA-2014-0382, 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.

B. 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

    On August 5, 2019, FMCSA published a notice announcing its decision
to renew exemptions for four individuals from the epilepsy and seizure
disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV in
interstate commerce and requested comments from the public (84 FR
38095). The public comment period ended on September 4, 2019, and no
comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  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 \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the four renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
epilepsy and seizure disorders prohibition in Sec.  391.41(b)(8).
    As of July 12, 2019, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following four individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (84 FR
38095):

Prince Austin, Jr. (OH)
Frank Cekovic (PA)
Martin Ford (MS)
Michael Weymouth (NH)

    The drivers were included in docket number FMCSA-2008-0355; FMCSA-
2011-0089; FMCSA-2014-0381; FMCSA-2014-0382. Their exemptions are
applicable as of July 12, 2019, and will expire on July 12, 2021.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (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
prior to being 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(b).

     Issued on: September 25, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-21279 Filed 9-30-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 4 (Friday, January 6, 2012)]
[Notices]
[Pages 788-789]
[FR Doc No: 2012-10]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-31-000]

Southern LNG Company, L.L.C.; Notice of Application

    Take notice that on December 15, 2011, Southern LNG Company, L.L.C.
(SLNG), 569 Brookwood Village, Suite 501, Birmingham, Alabama 35209,
filed an application in the above referenced docket pursuant to section
3(a) of the Natural Gas Act (NGA) and Part 153 of the Federal Energy
Regulatory Commission's (Commission) regulations requesting authority
to construct, install, own and operate a new 2,500 horsepower electric-
driven compressor unit at its liquefied natural gas (LNG) terminal
located at Elba Island, Georgia (Additional Compression) for the
purpose of providing adequate compression to allow boil-off gas
generated naturally within its storage tanks to be delivered to the
downstream pipelines without the need to regasify additional LNG as is
required with the use of recondensers, all as more fully set forth in
the application which is on file with the Commission and open to public
inspection. This filing is available for review at the Commission in
the Public Reference Room or may 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. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions regarding the application should be directed to Glenn
A. Sheffield, Director, Rates & Regulatory Affairs, Southern LNG
Company, L.L.C., 569 Brookwood Village, Suite 501, Birmingham, Alabama
35209, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit seven copies of filings made in the proceeding with the
Commission and must mail a copy to the applicant and to every other
party. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and

two copies of their comments to the Secretary of the Commission.
Environmental commentors will be placed on the Commission's
environmental mailing list, will receive copies of the environmental
documents, and will be notified of meetings associated with the
Commission's environmental review process. Environmental commentors
will not be required to serve copies of filed documents on all other
parties. However, the non-party commentors will not receive copies of
all documents filed by other parties or issued by the Commission
(except for the mailing of environmental documents issued by the
Commission) and will not have the right to seek court review of the
Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and seven copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426.
    Comment Date: 5 p.m. Eastern Time on January 19, 2012.

    Dated: December 29, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-10 Filed 1-5-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Proposed Rules]
[Pages 42381-42386]
[FR Doc No: 2013-16843]

Vol. 78

Monday,

No. 135

July 15, 2013

Part IV

Department of Health and Human Services

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 Food and Drug Administration

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21 CFR Parts 1 and 16

Administrative Detention of Drugs Intended for Human or Animal Use;
Draft Guidance for Industry on Circumstances That Constitute Delaying,
Denying, Limiting, or Refusing a Drug Inspection; Availability;
Proposed Rule and Notice

Federal Register / Vol. 78 , No. 135 / Monday, July 15, 2013 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 16

[Docket No. FDA-2013-N-0365]

Administrative Detention of Drugs Intended for Human or Animal
Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing a
regulation to implement administrative detention authority with respect
to drugs intended for human or animal use as authorized by amendments
made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the
Food and Drug Administration Safety and Innovation Act (FDASIA). Once
the applicable regulation is finalized, FDA's administrative detention
authority with respect to drugs will allow FDA to better protect the
integrity of the drug supply chain. Specifically, FDA will be able to
administratively detain drugs encountered during an inspection that an
officer or employee conducting an inspection has reason to believe are
adulterated or misbranded. This authority is intended to protect the
public by preventing distribution or subsequent use of drugs
encountered during inspections that are believed to be adulterated or
misbranded, until FDA has had time to consider what action it should
take concerning the drugs, and to initiate legal action, if
appropriate.

DATES: Submit either electronic or written comments on the proposed
rule by September 13, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0365, by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0365. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Charlotte Hinkle, Office of Regulatory
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 4345, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    FDA's administrative detention authority with respect to drugs
intended for human or animal use will allow FDA to better protect the
integrity of the drug supply chain. Specifically, administrative
detention is intended to protect the public by preventing distribution
or subsequent use of drugs encountered during inspections that may be
adulterated or misbranded, until FDA has had time to consider what
action it should take concerning the drugs, and to initiate legal
action, if appropriate. FDA already has the authority to
administratively detain devices, tobacco, and foods that FDA has reason
to believe are adulterated or misbranded.
    FDA is issuing this proposed rule under section 304(g) of the FD&C
Act, as amended by section 709 of FDASIA, and section 701 of the FD&C
Act (21 U.S.C. 334(g) and 371). Section 304(g) also authorizes FDA to
administratively detain devices and tobacco products.

Summary of the Major Provisions

    This notice contains a proposed rule regarding the administrative
detention of drugs. FDA proposes to amend parts 1 and 16 (21 CFR parts
1 and 16) to create an implementing rule for this authority. The
proposed changes set forth the procedures for detention of drugs
believed to be adulterated or misbranded and amend the scope of FDA's
part 16 regulatory hearing procedures to include the administrative
detention of drugs.

Costs and Benefits

    The primary public health benefits from adoption of the proposed
rule would be the value of the illnesses or deaths prevented because
the Agency administratively detained a drug it has reason to believe is
adulterated or misbranded; this benefit occurs only if the drug would
not have been prevented from entering the market using one of the
Agency's other enforcement tools. The estimated primary costs to FDA
include marking or labeling the detained product and costs associated
with appeals of detention orders. The Agency estimates the net annual
social costs to be between $0 and $591,480.

I. Background

    On July 9, 2012, President Obama signed the Food and Drug
Administration Safety and Innovation Act (FDASIA, Pub. L. 112-144) into
law. Title VII of FDASIA provides FDA with important new authorities to
help it better protect the integrity of the drug supply chain. One of
those new authorities is section 709, which amends section 304(g) of
the FD&C Act (21 U.S.C. 334(g)) to provide FDA with administrative
detention authority with respect to drugs. Section 304(g) of the FD&C
Act, as amended by FDASIA, provides FDA the same authority to detain
drugs that section 304(g) already provides FDA with respect to devices
and tobacco products. Once implementing regulations with respect to
drugs are finalized, the amendments to section 304(g) of the FD&C Act
will take effect, allowing FDA to administratively detain drugs that an
officer or employee conducting an inspection under section 704 of the
FD&C Act has reason to believe are adulterated or misbranded.
    FDA's administrative detention authority with respect to drugs will
allow FDA to drive safety and quality through the drug supply chain.
Use of this authority is intended to protect the public by preventing
distribution or subsequent use of drugs encountered during inspections
that may be adulterated or misbranded, until FDA has had time to
consider what action it should take concerning the drugs, and to
initiate legal action, if appropriate.
    Section 709 of FDASIA requires the Secretary to ``consult with
stakeholders, including manufacturers of drugs'' before issuing
implementing regulations. Section 709 of FDASIA also requires FDA to
issue a notice of proposed rulemaking that includes the proposed
regulation and provides a period of at least 60 days for comments on
the proposed regulation. Finally,

section 709 of FDASIA states that FDA must ``publish the final
regulation not less than 30 days before the regulation's effective
date'' and states that FDA must issue regulations no later than 2 years
after enactment of FDASIA.
    On April 9, 2013, FDA published a document in the Federal Register
that opened a 30-day public docket to solicit input from all relevant
stakeholders regarding FDA's issuance of regulations for the
administrative detention of drugs (78 FR 21085). The docket was
intended to ensure that stakeholders had an opportunity to provide
comments before FDA issued proposed regulations on administrative
detention with respect to drugs and to ensure that such information
submitted to FDA was available to all interested persons in a timely
fashion.
    The 30-day public docket closed on May 9, 2013. FDA received one
responsive, non-substantive comment. The Agency did not consider
nonresponsive comments in developing this proposed rule. FDA notes that
this announcement regarding the proposed rule also solicits input from
all relevant stakeholders before FDA issues final regulations to
implement its administrative detention authority with respect to drugs.
FDA modeled the proposed regulations for the administrative detention
of drugs on the existing regulations covering administrative detention
of devices (see 21 CFR 800.55). FDA did so because of identical
statutory authority underlying the regulations (21 U.S.C. 334(g)).

II. Proposed Changes to Current Regulations

A. Proposed Revisions to Part 1

    FDA proposes to amend part 1 (21 CFR part 1) to create an
implementing regulation for the administrative detention of drugs. The
proposed amendment to part 1 consists of one section, Sec.  1.501,
under a new subpart, which is titled ``Subpart L--Administrative
Detention of Drugs Intended for Human or Animal Use.'' Proposed Sec.
1.501 sets forth the procedures for the administrative detention of
drugs encountered during an inspection that are believed to be
adulterated or misbranded. The new regulation is closely modeled on the
current regulation for the administrative detention of devices (21 CFR
800.55). There are minor differences from the device regulation,
including updates to statutory references to refer to drugs instead of
devices and changes to language to conform to current Federal Register
requirements.

B. Proposed Revisions to Part 16

    The proposed amendment to part 16 is a technical change. This
change amends a statement in Sec.  16.1 so that the scope of part 16
regulatory hearing procedures will also include administrative
detention authority with respect to drugs.

III. Effective Date

    FDA intends that the effective date of the new requirements will be
30 days after publication of a final rule in the Federal Register.
Section 709 of FDASIA states that FDA's new authority under section
304(g) of the FD&C Act shall not take effect until FDA issues a final
regulation, and section 709 requires FDA to ``publish the final
regulation not less than 30 days before the regulation's effective
date.'' Finally, section 709 of FDASIA requires that no later than 2
years after enactment of FDASIA, regulations to implement
administrative detention authority with respect to drugs must be
issued. Therefore, FDA intends to issue the final rule for
administrative detention authority with respect to drugs by July 9,
2014, with an effective date for the final rule no later than August 8,
2014.

IV. Legal Authority

    FDA is issuing this proposed rule under sections 304(g) and 701 of
the FD&C Act and section 709 of FDASIA. Section 709 of FDASIA provides
FDA authority to issue regulations regarding administrative detention
authority with respect to drugs. Section 304(g) of the FD&C Act
includes FDA's administrative detention authority with respect to
drugs. The proposed rule is necessary for efficient enforcement of the
FD&C Act.

V. Analysis of Impacts (Summary of the Initial Regulatory Impact
Analysis)

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule would not be an
economically significant regulatory action as defined by Executive
Order 12866.
    If a rule has a significant economic impact on a substantial number
of small businesses, the Regulatory Flexibility Act requires Agencies
to analyze regulatory alternatives that would minimize any significant
impact of a rule on small entities. FDA has determined that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The primary public health benefits from adoption of the proposed
rule would be the value of the illnesses or deaths prevented because
the Agency administratively detained a drug it has reason to believe is
adulterated or misbranded; this benefit occurs only if the drug would
not have been prevented from entering the market using one of the
Agency's other enforcement tools. There may also be benefits from
deterrence if administrative detention increases the likelihood
misbranded or adulterated products will not be marketed in the future.
    The estimated primary costs to FDA include marking or labeling the
detained product and costs associated with appeals of the detention
orders. However, other costs, such as loss in market value of a
detained drug, may be incurred if FDA revokes the detention order on
appeal. Given the history of administrative detention use with medical
devices and foods, the likelihood is low of FDA issuing a detention
order that is later revoked on appeal.
    We estimate the annual costs using a range of 0 to 20
administrative detentions performed each year. The Agency estimates the
net annual social costs to be between $0 and $591,480. The present
discounted value over 20 years would be in the range of $0 to
$8,799,729 at a 3 percent discount rate and in the range of $0 to
$6,266,148 at a 7 percent discount rate.

    FDA has examined the economic implications of the final rule as
required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. We find that this proposed rule would not have a significant
economic impact on a substantial number of small entities. This
analysis, together with other relevant sections of this document,
serves as the Initial Regulatory Flexibility Analysis, as required
under the Regulatory Flexibility Act.

VI. Paperwork Reduction Act of 1995

    FDA concludes that the requirements proposed in this proposed rule
are not subject to review by the Office of Management and Budget
because they do not constitute a ``collection of information'' under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3518(c)(1)(B)(ii)).

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects 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.
Accordingly, the Agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

VIII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR parts 1 and
16 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as
follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374,
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.

0
2. Add subpart L, consisting of Sec.  1.501, to read as follows:

Subpart L--Administrative Detention of Drugs Intended for Human or
Animal Use

Sec.  1.501  Administrative detention of drugs.

    (a) General. This section sets forth the procedures for detention
of drugs believed to be adulterated or misbranded. Administrative
detention is intended to protect the public by preventing distribution
or use of drugs encountered during inspections that may be adulterated
or misbranded, until the Food and Drug Administration (FDA) has had
time to consider what action it should take concerning the drugs, and
to initiate legal action, if appropriate. Drugs that FDA orders
detained may not be used, moved, altered, or tampered with in any
manner by any person during the detention period, except as authorized
under paragraph (h) of this section, until FDA terminates the detention
order under paragraph (j) of this section, or the detention period
expires, whichever occurs first.
    (b) Criteria for ordering detention. Administrative detention of
drugs may be ordered in accordance with this section when an authorized
FDA representative, during an inspection under section 704 of the
Federal Food, Drug, and Cosmetic Act, has reason to believe that a
drug, as defined in section 201(g) of the Federal Food, Drug, and
Cosmetic Act, is adulterated or misbranded.
    (c) Detention period. The detention is to be for a reasonable
period that may not exceed 20 calendar days after the detention order
is issued, unless the FDA District Director in whose district the drugs
are located determines that a greater period is required to seize the
drugs, to institute injunction proceedings, or to evaluate the need for
legal action, in which case the District Director may authorize
detention for 10 additional calendar days. The additional 10-calendar-
day detention period may be ordered at the time the detention order is
issued or at any time thereafter. The entire detention period may not
exceed 30 calendar days, except when the detention period is extended
under paragraph (g)(6) of this section. An authorized FDA
representative may, in accordance with paragraph (j) of this section,
terminate a detention before the expiration of the detention period.
    (d) Issuance of detention order. (1) The detention order must be
issued in writing, in the form of a detention notice, signed by the
authorized FDA representative who has reason to believe that the drugs
are adulterated or misbranded, and issued to the owner, operator, or
agent in charge of the place where the drugs are located. If the owner
or the user of the drugs is different from the owner, operator, or
agent in charge of the place where the drugs are detained, a copy of
the detention order must be provided to the owner or user of the drugs
if the owner's or user's identity can be readily determined.
    (2) If detention of drugs in a vehicle or other carrier is ordered,
a copy of the detention order must be provided to the shipper of record
and the owner of the vehicle or other carrier, if their identities can
be readily determined.
    (3) The detention order must include the following information:
    (i) A statement that the drugs identified in the order are detained
for the period shown;
    (ii) A brief, general statement of the reasons for the detention;
    (iii) The location of the drugs;
    (iv) A statement that these drugs are not to be used, moved,
altered, or tampered with in any manner during that period, except as
permitted under paragraph (h) of this section, without the written
permission of an authorized FDA representative;
    (v) Identification of the detained drugs;
    (vi) The detention order number;

    (vii) The date and hour of the detention order;
    (viii) The period of the detention;
    (ix) The text of section 304(g) of the Federal Food, Drug, and
Cosmetic Act and paragraphs (g)(1) and (g)(2) of this section;
    (x) A statement that any informal hearing on an appeal of a
detention order must be conducted as a regulatory hearing under part 16
of this chapter, with certain exceptions described in paragraph (g)(3)
of this section; and
    (xi) The location and telephone number of the FDA district office
and the name of the FDA District Director.
    (e) Approval of detention order. A detention order, before
issuance, must be approved by the FDA District Director in whose
district the drugs are located. If prior written approval is not
feasible, prior oral approval must be obtained and confirmed by written
memorandum within FDA as soon as possible.
    (f) Labeling or marking a detained drug. An FDA representative
issuing a detention order under paragraph (d) of this section must
label or mark the drugs with official FDA tags that include the
following information:
    (1) A statement that the drugs are detained by the U.S. Government
in accordance with section 304(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 334(g)).
    (2) A statement that the drugs must not be used, moved, altered, or
tampered with in any manner for the period shown, without the written
permission of an authorized FDA representative, except as authorized in
paragraph (h) of this section.
    (3) A statement that the violation of a detention order or the
removal or alteration of the tag is punishable by fine or imprisonment
or both (section 303 of the Federal Food, Drug, and Cosmetic Act, 21
U.S.C. 333).
    (4) The detention order number, the date and hour of the detention
order, the detention period, and the name of the FDA representative who
issued the detention order.
    (g) Appeal of a detention order. (1) A person who would be entitled
to claim the drugs, if seized, may appeal a detention order. Any appeal
must be submitted in writing to the FDA District Director in whose
district the drugs are located within 5 working days of receipt of a
detention order. If the appeal includes a request for an informal
hearing, as defined in section 201(x) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(x)), the appellant must request either that
a hearing be held within 5 working days after the appeal is filed or
that the hearing be held at a later date, which must not be later than
20 calendar days after receipt of a detention order.
    (2) The appellant of a detention order must state the ownership or
proprietary interest the appellant has in the detained drugs. If the
detained drugs are located at a place other than an establishment owned
or operated by the appellant, the appellant must include documents
showing that the appellant would have legitimate authority to claim the
drugs if seized.
    (3) Any informal hearing on an appeal of a detention order must be
conducted as a regulatory hearing under regulation in accordance with
part 16 of this chapter, except that:
    (i) The detention order under paragraph (d) of this section, rather
than the notice under Sec.  16.22(a) of this chapter, provides notice
of opportunity for a hearing under this section and is part of the
administrative record of the regulatory hearing under Sec.  16.80(a) of
this chapter;
    (ii) A request for a hearing under this section should be addressed
to the FDA District Director;
    (iii) The last sentence of Sec.  16.24(e) of this chapter, stating
that a hearing may not be required to be held at a time less than 2
working days after receipt of the request for a hearing, does not apply
to a hearing under this section;
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a)
of this chapter, describes the FDA employees, i.e., regional food and
drug directors, who preside at hearings under this section.
    (4) The presiding officer of a regulatory hearing on an appeal of a
detention order, who also must decide the appeal, must be a regional
food and drug director (i.e., a director of an FDA regional office
listed in part 5, subpart M of this chapter) who is permitted by Sec.
16.42(a) of this chapter to preside over the hearing.
    (5) If the appellant requests a regulatory hearing and requests
that the hearing be held within 5 working days after the appeal is
filed, the presiding officer must, within 5 working days, hold the
hearing and render a decision affirming or revoking the detention.
    (6) If the appellant requests a regulatory hearing and requests
that the hearing be held at a date later than within 5 working days
after the appeal is filed, but not later than 20 calendar days after
receipt of a detention order, the presiding officer must hold the
hearing at a date agreed upon by FDA and the appellant. The presiding
officer must decide whether to affirm or revoke the detention within 5
working days after the conclusion of the hearing. The detention period
extends to the date of the decision even if the 5-working-day period
for making the decision extends beyond the otherwise applicable 20-
calendar-day or 30-calendar-day detention period.
    (7) If the appellant appeals the detention order but does not
request a regulatory hearing, the presiding officer must render a
decision on the appeal affirming or revoking the detention within 5
working days after the filing of the appeal.
    (8) If the presiding officer affirms a detention order, the drugs
continue to be detained until FDA terminates the detention under
paragraph (j) of this section or the detention period expires,
whichever occurs first.
    (9) If the presiding officer revokes a detention order, FDA must
terminate the detention under paragraph (j) of this section.
    (h)(1) Movement of detained drugs. Except as provided in this
paragraph, no person may move detained drugs within or from the place
where they have been ordered detained until FDA terminates the
detention under paragraph (j) of this section or the detention period
expires, whichever occurs first.
    (2) If detained drugs are not in final form for shipment, the
manufacturer may move them within the establishment where they are
detained to complete the work needed to put them in final form. As soon
as the drugs are moved for this purpose, the individual responsible for
their movement must orally notify the FDA representative who issued the
detention order, or another responsible district office official, of
the movement of the drugs. As soon as the drugs are put in final form,
they must be segregated from other drugs, and the individual
responsible for their movement must orally notify the FDA
representative who issued the detention order, or another responsible
district office official, of their new location. The drugs put in final
form must not be moved further without FDA approval.
    (3) The FDA representative who issued the detention order, or
another responsible district office official, may approve, in writing,
the movement of detained drugs for any of the following purposes:
    (i) To prevent interference with an establishment's operations or
harm to the drugs;
    (ii) To destroy the drugs;
    (iii) To bring the drugs into compliance;
    (iv) For any other purpose that the FDA representative who issued
the detention order, or other responsible district office official,
believes is appropriate in the case.

    (4) If an FDA representative approves the movement of detained
drugs under paragraph (h)(3) of this section, the detained drugs must
remain segregated from other drugs and the person responsible for their
movement must immediately orally notify the official who approved the
movement of the drugs, or another responsible FDA district office
official, of the new location of the detained drugs.
    (5) Unless otherwise permitted by the FDA representative who is
notified of, or who approves, the movement of drugs under this
paragraph, the required tags must accompany the drugs during and after
movement and must remain with the drugs until FDA terminates the
detention or the detention period expires, whichever occurs first.
    (i) Actions involving adulterated or misbranded drugs. If FDA
determines that the detained drugs, including any that have been put in
final form, are adulterated or misbranded, or both, it may initiate
legal action against the drugs or the responsible individuals, or both,
or request that the drugs be destroyed or otherwise brought into
compliance with the Federal Food, Drug, and Cosmetic Act under FDA's
supervision.
    (j) Detention termination. If FDA decides to terminate a detention
or when the detention period expires, whichever occurs first, an FDA
representative authorized to terminate a detention will issue a
detention termination notice releasing the drugs to any person who
received the original detention order or that person's representative
and will remove, or authorize in writing the removal of, the required
labels or tags.
    (k) Recordkeeping requirements. (1) After issuance of a detention
order under paragraph (d) of this section, the owner, operator, or
agent in charge of any factory, warehouse, other establishment, or
consulting laboratory where detained drugs are manufactured, processed,
packed, or held, must have, or establish, and maintain adequate records
relating to how the detained drugs may have become adulterated or
misbranded, records on any distribution of the drugs before and after
the detention period, records on the correlation of any in-process
detained drugs that are put in final form under paragraph (h) of this
section to the completed drugs, records of any changes in, or
processing of, the drugs permitted under the detention order, and
records of any other movement under paragraph (h) of this section.
Records required under this paragraph must be provided to the FDA on
request for review and copying. Any FDA request for access to records
required under this paragraph must be made at a reasonable time, must
state the reason or purpose for the request, and must identify to the
fullest extent practicable the information or type of information
sought in the records to which access is requested.
    (2) Records required under this paragraph must be maintained for a
maximum period of 2 years after the issuance of the detention order or
for such other shorter period as FDA directs. When FDA terminates the
detention or when the detention period expires, whichever occurs first,
FDA will advise all persons required under this paragraph to keep
records concerning that detention whether further recordkeeping is
required for the remainder of the 2-year, or shorter, period. FDA
ordinarily will not require further recordkeeping if the Agency
determines that the drugs are not adulterated or misbranded or that
recordkeeping is not necessary to protect the public health, unless the
records are required under other regulations in this chapter (e.g., the
good manufacturing practice regulation in part 211 of this chapter).

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
3. The authority citation for 21 CFR part 16 is revised to read as
follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467F, 679, 821, 1034; 42 U.S.C. 201-262, 263b, 364.
0
4. Revise the first sentence of Sec.  16.1 paragraph (b)(1) to read as
follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (1) Statutory provisions:
    Section 304(g) of the act relating to the administrative detention
of devices and drugs (see Sec. Sec.  800.55(g) and 1.501(g) of this
chapter). * * *

    Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16843 Filed 7-12-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 43 (Tuesday, March 7, 2017)]
[Notices]
[Page 12817]
[FR Doc No: 2017-04377]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13318-003]

Swan Lake North Pumped Storage Project; Notice of Meeting

    Commission staff will meet with representatives of the Klamath
Tribes (Tribes) regarding the proposed Swan Lake North Pumped Storage
Project (Project No. 13318-003). The meeting will be held at the
location and time listed below:

Klamath Tribes, Tribal Administration Building, 501 Chiloquin Blvd.,
Chiloquin, OR 97624, Phone:<PHONE_NUMBER>, Thursday, March 30, 2017,
1:00 p.m. PDT

    Members of the public, intervenors, agencies, and the applicant, in
the referenced proceeding may attend this meeting; however,
participation will be limited to only tribal representatives and
Commission staff. If the Tribes decide to disclose information about a
specific location which could create a risk or harm to an archeological
site or Native American cultural resource, the public will be excused
for that portion of the meeting.\1\ If you plan to attend this meeting,
please contact Dr. Frank Winchell at the Federal Energy Regulatory
Commission. He can be reached at<PHONE_NUMBER>.
---------------------------------------------------------------------------

    \1\ Protection from public disclosure involving this kind of
specific information is based upon 18 CFR 4.32(b)(3)(ii) of the
Commission's regulations implementing the Federal Power Act.

    Dated: March 1, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-04377 Filed 3-6-17; 8:45 am]
 BILLING CODE 6717-01-P