[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18973-18974]
[FR Doc No: 2021-07447]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR21-7-000]

Seahawk Pipeline LLC; Notice of Petition for Declaratory Order

    Take notice that on March 30, 2021, pursuant to Rule 207(a)(2) of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2) (2019), Seahawk Pipeline,
LLC (``Seahawk'') respectfully submits its petition that the Commission
issue a declaratory order approving Seahawk's proposed rate structures,
service priority rights, and prorationing provisions for shippers and
various aspects of the Transportation Service Agreement for the Seahawk
Pipeline, all as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically may mail similar
pleadings to the Federal Energy Regulatory Commission, 888 First Street
NE, Washington, DC 20426.

Hand delivered submissions in docketed proceedings should be delivered
to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance with any FERC Online
service, please email<EMAIL_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on April 30, 2021.

    Dated: April 6, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-07447 Filed 4-9-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Pages 49741-49743]
[FR Doc No: 2019-20543]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3805]

The Accreditation Scheme for Conformity Assessment Pilot Program;
Draft Guidance for Industry, Accreditation Bodies, Testing
Laboratories, 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 ``The Accreditation
Scheme for Conformity Assessment (ASCA) Pilot Program.'' The Pilot
Accreditation Scheme for Conformity Assessment Program (hereafter
referred to as the ASCA Pilot) is authorized under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). In accordance with amendments made
to the FD&C Act by the FDA Reauthorization Act of 2017 (FDARA) and as
part of the enactment of the Medical Device User Fee Amendments of 2017
(MDUFA IV), FDA was directed to issue a draft guidance regarding the
goals and implementation of the ASCA Pilot. The establishment of the
goals, scope, procedures, and a suitable framework for the voluntary
ASCA Pilot supports the Agency's continued efforts to use its
scientific resources effectively to protect and promote public health
by simplifying certain aspects of premarket review, thereby reducing
burdens on the Agency for individual submissions. FDA believes the
voluntary ASCA Pilot may further encourage international harmonization
of medical device regulation because it incorporates elements, where
appropriate, from a well-established set of international conformity
assessment practices and standards (e.g., ISO/IEC 17000 series). The
voluntary ASCA Pilot does not supplant or alter any other existing
statutory or regulatory requirements governing the decision-making
process for premarket submissions. 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 December 23, 2019 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-2019-D-3805 for ``The Accreditation Scheme for Conformity
Assessment (ASCA) Pilot Program; Draft Guidance for Industry,
Accreditation Bodies, Testing Laboratories, 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
``The Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Program; Draft Guidance for Industry, Accreditation Bodies, Testing
Laboratories, and Food and Drug Administration Staff'' to the Office of
Policy, 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 or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Erin Cutts, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5554, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Reauthorization Act of 2017 (FDARA) amended section 514 of
the FD&C Act (21 U.S.C. 360d) by adding a new subsection (d) with the
title ``Pilot Accreditation Scheme for Conformity Assessment'' (see
Pub. L. 115-52, section 205). The new section 514(d) requires FDA to
establish a pilot program under which testing laboratories may be
accredited by accreditation bodies meeting criteria specified by FDA to
assess the conformance of a device within certain FDA-recognized
standards. Determinations by testing laboratories so accredited that a
device conforms with an eligible standard included as part of the pilot
program shall be accepted by FDA for the purposes of demonstrating such
conformity unless FDA finds that a particular such determination shall
not be so accepted.
    The statute provides that FDA may review determinations by
accredited testing laboratories, including by conducting periodic
audits of such determinations or processes of accreditation bodies or
testing laboratories. Following such a review, or if FDA becomes aware
of information materially bearing on safety or effectiveness of a
device assessed by an accredited testing laboratory, FDA may take
additional measures as determined appropriate, including suspension or
withdrawal of accreditation of a testing laboratory or a request for
additional information regarding a specific device.
    Under the ASCA Pilot's conformity assessment scheme, recognized
accreditation bodies accredit testing laboratories using ASCA program
specifications associated with each eligible standard and ISO/IEC
17025:2017: General requirements for the competence of testing and
calibration laboratories. ASCA-accredited testing laboratories may
conduct testing to determine conformance of a device with at least one
of the standards eligible for inclusion in the ASCA Pilot. When an
ASCA-accredited testing laboratory conducts such testing, it may
provide a complete test report to the device manufacturer containing
the elements listed in the ASCA program specifications. A device
manufacturer who utilizes an ASCA-accredited testing laboratory to
perform testing in accordance with the provisions of the ASCA Pilot can
then include a declaration of conformity with supplemental
documentation (including a summary test report) as part of a premarket
submission to FDA.
    FDA held a public workshop entitled ``Accreditation Scheme for
Conformity Assessment of Medical Devices to Food and Drug
Administration--Recognized Standards'' on May 22-23, 2018,\1\ to obtain
input and recommendations from stakeholders about the ASCA Pilot,
including its goals and scope as well as a suitable framework and
procedures to facilitate implementation. The ASCA Pilot is predicated
on the processes and policies outlined in this guidance regarding
demonstration of competence and program participation by accreditation
bodies and testing laboratories.
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    \1\ Federal Register Notice: https://www.federalregister.gov/documents/2018/01/16/2018-00551/accreditation-scheme-for-conformity-assessment-of-medical-devices-to-food-and-drug.
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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 the
``Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Program.'' 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or https://www.regulations.gov. Persons unable to
download an electronic copy of ``The Accreditation Scheme for
Conformity Assessment (ASCA) Pilot Program; Draft Guidance for
Industry, Accreditation Bodies, Testing Laboratories, 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 17037 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    In the Federal Register of September 5, 2019 (84 FR 46737), FDA
requested public comment on the collections of information associated
with the ASCA Pilot. The proposed information collection and our burden
estimate is substantially the same, and is meant to encompass, the
information collections proposed in the draft guidance.
    In addition, this draft guidance refers to previously approved
collections of information. 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 the

following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
814, subparts A through E......  Premarket Approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo Classification        0910-0844
 Process (Evaluation of           Process.
 Automatic Class III
 Designation)''.
312............................  Investigational New           0910-0014
                                  Drug Application.
601............................  Biologics License             0910-0338
                                  Application.
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    Dated: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20543 Filed 9-20-19; 8:45 am]
 BILLING CODE 4164-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ OSWER/ CEPPO 2. OMB control number b. G None a 2050  0072 3. Type of information collection ( check one) a. G New collection b. x Revision of a currently approved collection c. Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. x Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. __ Three years from approval date b. X Other Specify: 10/ 31/ 2004 7. Title: Community Right to Know Reporting Requirements under sections 311 and 312 of the Emergency Planning and Community Right to Know Act ( EPCRA)  Minimal Hazard Proposed Rule 8. Agency form number( s) ( If applicable): ICR 1352.09 9. Keywords: Community Right to Know, Emergency Planning, Preparedness, EPCRA 10. Abstract: The authority for these requirements is sections 311 and 312 of the Emergency Planning and Community Right to Know Act ( EPCRA), 1986 ( 42 U. S. C. 11011, 11012). EPCRA section 311 requires owners and operators of facilities subject to OSHA HCS to submit a list of chemicals or MSDSs ( for those chemicals that exceed thresholds, specified in 40 CFR part 370 ) to the State Emergency Response Commission ( SERC), Local Emergency Planning Committee ( LEPC) and the local fire department ( LFD) with jurisdiction over their facility. This is a one time requirement unless a new facility becomes subject to the regulations or updating the information by facilities that are already covered by the regulations. EPCRA section 312 requires owners and operators of facilities subject to OSHA HCS to submit an inventory form ( for those chemicals that exceed the thresholds, specified in 40 CFR part 370) to the SERC, LEPC, and LFD with jurisdiction over their facility. This activity is to be completed on March 1 of each year, on the inventory of chemicals in the previous calendar year. EPA is proposing to limit the number of chemicals subject to routine reporting under section 312 by establishing an infinite threshold for chemicals that pose minimal hazards and minimal risks for the community and emergency responders.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. p Business or other for profit e. p Federal Government c. Not for profit institutions f. p State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 504,000 b. Total annual responses 504,000 1. Percentage of these responses collected electronically 60 % c. Total hours requested 2,028,701 d. Current OMB inventory 2,028,700 e. Difference 1 f. Explanation of difference 1. Program Change __ _ 1__ 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 5 b. Total annual costs ( O& M) 6,386 c. Total annualized cost requested 6,391 d. Current OMB inventory 6,390 e. Difference 1 __ f. Explanation of difference 1. Program change 1___ 2. Adjustment 0 ____

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. x Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. x Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. X Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes x No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Sicy Jacob Phone: 202 564 8019 OMB 83 I 10/ 95  19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95