[Federal Register Volume 85, Number 25 (Thursday, February 6, 2020)]
[Notices]
[Page 6943]
[FR Doc No: 2020-02351]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 619-164]

Pacific Gas and Electric Company and City of Santa Clara,
California; Notice of Availability of the Final Environmental Impact
Statement for the Bucks Creek Hydropwer Project

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380, the Office of Energy Projects has
reviewed the application for license for the Bucks Creek Hydropower
Project (FERC No. 619) and has prepared a final environmental impact
statement (EIS) for the project. The project is located on Bucks,
Grizzly, and Milk Ranch Creeks in Plumas County, California. Portions
of the project are located within the Plumas National Forest.
    The final EIS contains staff's evaluations of the co-applicants'
proposal and the alternatives for relicensing the Bucks Creek
Hydropower Project. The final EIS documents the views of governmental
agencies, non-governmental organizations, affected Indian tribes, the
public, the license applicants, and Commission staff.
    A copy of the final EIS is available for review in the Commission's
Public Reference Branch, Room 2A, located at 888 First Street NE,
Washington, DC 20426. The final EIS also may be viewed on the
Commission's website at http://www.ferc.gov under 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
Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY).
    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, contact FERC
Online Support.
    For further information, please contact Alan Mitchnick at (202)
502-6074 or at<EMAIL_ADDRESS>
    Dated: January 28, 2020.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2020-02351 Filed 2-5-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65680-65681]
[FR Doc No: 2018-27678]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-3592 and FDA-2017-E-3616]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ABSORB GT1 BIORESORBABLE SCAFFOLD

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ABSORB GT1 Bioresorbable
Scaffold and is publishing this notice of that determination as
required by law. FDA has made the determination because of the
submission of applications to the Director of the U.S. Patent and
Trademark Office (USPTO), Department of Commerce, for the extension of
a patent which claims that medical device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 19, 2019. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 19,
2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 19, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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 Nos.
FDA-2017-E-3592 and FDA-2017-E-3616 for Determination of Regulatory
Review Period for Purposes of Patent Extension; ABSORB GT1
Bioresorbable Scaffold. Received comments, those filed in a timely
manner (see ADDRESSES), 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 numbers, 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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count

toward the actual amount of extension that the Director of USPTO may
award (half the testing phase must be subtracted as well as any time
that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a medical
device will include all of the testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
    FDA has approved for marketing the medical device ABSORB GT1
BIORESORBABLE SCAFFOLD. ABSORB GT1 BIORESORBABLE SCAFFOLD is indicated
for improving coronary luminal diameter in patients with ischemic heart
disease due to de novo native coronary artery lesions >=2.5 mm to
<=3.75 mm in diameter in lesions. Subsequent to this approval, the
USPTO received a patent term restoration application for ABSORB GT1
BIORESORBABLE SCAFFOLD (U.S. Patent Nos. 7,971,333 and 8,323,329) from
Abbott Cardiovascular Systems Inc., and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated August 1, 2017, FDA advised the USPTO
that this medical device had undergone a regulatory review period and
that the approval of ABSORB GT1 BIORESORBABLE SCAFFOLD represented the
first permitted commercial marketing or use of the product. Thereafter,
the USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ABSORB GT1 BIORESORBABLE SCAFFOLD is 1,303 days. Of this time, 932 days
occurred during the testing phase of the regulatory review period,
while 371 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: December 12, 2012. The applicant claims that
the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
March 19, 2009. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
December 12, 2012, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): July 1,
2015. The applicant claims June 30, 2015, as the date the premarket
approval application (PMA) for ABSORB GT1 BIORESORBABLE SCAFFOLD (PMA
P150023) was initially submitted. However, FDA records indicate that
PMA P150023 was submitted on July 1, 2015.
    3. The date the application was approved: July 5, 2016. FDA has
verified the applicant's claim that PMA P150023 was approved on July 5,
2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,100 or 841 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27678 Filed 12-20-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 75 (Wednesday, April 18, 2018)]
[Notices]
[Page 17171]
[FR Doc No: 2018-08074]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD18-5-000]

Notice Requesting Questions and Comments on Fiscal Year 2017
Other Federal Agency Cost Submissions; Review of Cost Submittals by
Other Federal Agencies for Administering Part I of the Federal Power
Act

    In its Order On Rehearing Consolidating Administrative Annual
Charges Bill Appeals And Modifying Annual Charges Billing Procedures,
109 FERC 61,040 (2004) (October 8 Order) the Commission set forth an
annual process for Other Federal Agencies (OFAs) to submit their costs
related to Administering Part I of the Federal Power Act. Pursuant to
the established process the Chief of Revenue and Receivables, Financial
Management Division, Office of the Executive Director, on October 5,
2017, issued a letter requesting the OFAs to submit their costs by
December 31, 2017 using the OFA Cost Submission Form.
    Upon receipt of the agency submissions, the Commission posted the
information in eLibrary, and issued, on March 7, 2018, a notice
announcing the date for a technical conference to review the submitted
costs. On March 27, 2018 the Commission held the technical conference.
Technical conference transcripts, submitted cost forms, and detailed
supporting documents are all available for review under Docket No.
AD18-5. These documents are accessible on-line at http://www.ferc.gov,
using the eLibrary link and are available for review in the
Commission's Public Reference Room in Washington, DC.
    Interested parties may file specific questions and comments on the
FY 2017 OFA cost submissions with the Commission under Docket No. AD18-
5, no later than April 26, 2018. Once filed, the Commission will
forward the questions and comments to the OFAs for response.
    Anyone with questions pertaining to the technical conference or
this notice should contact Raven A. Rodriguez at<PHONE_NUMBER> (via
email at [email protected]).

    Dated: April 12, 2018. .
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-08074 Filed 4-17-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Notices]
[Pages 28322-28323]
[FR Doc No: 2019-12856]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3412-EM; Docket ID FEMA-2019-0001]

Kansas; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION:  Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of Kansas (FEMA-3412-EM), dated May 28, 2019, and related
determinations.

DATES: This amendment was issued May 31, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident for
this emergency has been expanded to include tornadoes.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidential Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-12856 Filed 6-17-19; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: March 25, 2009 (Volume 74, Number 56)]
[Notices]
[Page 12862-12865]
[DOCID:fr25mr09-101]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0075; FRL-8398-3]

Pirimicarb, Iprodione, Amides, Boscalid, Pyraclostrobin,
Mefenoxam, Propyzamide (Pronamide), Pirimiphos-methyl, Thiobencarb,
1,2-benzisothiazolin-3-one, Fludioxonil, Esfenvalerate; Withdrawal of
Tolerance Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY:  Notice is being provided that the following petitions
(PP 0E6102, 1E6427, 2E6388, 2E6509, 4E6868, 5E7013, 5E7014,
5F7018, 6E7047, 6E7048, 6E7056, 6E7164, 6E7165, 7E7213, 7E7309, 7E7238,
7F7295 and 9E5075) to establish pesticide tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, have been
withdrawn by the petitioners.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Notice Apply to Me?

    Although EPA regulations permit tolerance petitions to be withdrawn
by the petitioner, notice is being provided

to the public in general. Since various individuals or entities may be
interested, the Agency has not attempted to describe all the specific
entities that may be interested in this action. If you have any
questions regarding this action, please consult the person listed under
FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    1. Docket. EPA has established a docket for this notice under
docket identification (ID) number EPA-HQ-OPP-2008-0075. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the Federal Register
listings at http://www.epa.gov/fedrgstr.

II. What Action is the Agency Taking?

    Under section 408(d) of the FFDCA, 21 U.S.C. 346a , EPA is
authorized to establish tolerances for pesticide residues in or on food
based on a petition from any person. Ordinarily, EPA resolves these
petitions either by granting or denying them (21 U.S.C. 346a(d)(4)).
EPA's regulations, however, allow petitions to be withdrawn by the
petitioner without prejudice to refiling the petition at a later date
(40 CFR 180.8). EPA has received notifications from various petitioners
withdrawing, partially or completely, the following tolerances: PP
0E6102, 1E6427, 2E6388, 2E6509, 4E6868, 5E7013, 5E7014, 5F7018, 6E7047,
6E7048, 6E7056, 6E7164, 6E7165, 7E7213, 7E7309, 7E7238, 7F7295 and
9E5075. By this action, EPA is providing the general public with notice
that the above-cited petitions have been withdrawn by the petitioners.
The petitioners may refile these petitions in the future without
prejudice. The petitions and the withdrawal notifications are described
below.

A. PP 0E61012; PP 2E6388; PP 2E6509 (pirimicarb)

    EPA issued a notice in the Federal Register of July 12, 2006 (71 FR
39315) (FRL-8075-1), which announced the submission of pesticide
petitions (PP 2E6388; PP 2E6509; and PP 0E6102) (EPA-HQ-OPP-2006-0512)
by the Interregional Research Project No. 4 (IR-4), 500 College Rd.
East, Suite 201W, Princeton, NJ 08540. These petitions requested that
EPA amend 40 CFR part 180 by establishing tolerances for residues of
the insecticide 2-(dimethylamino)-5,6-dimethyl-4-pyrimidinyl
dimethylcarbamate (9Cl) and its two carbamate metabolites: desmethyl
pirimicarb and desmethylformamido pirimicarb, expressed as desmethyl
pirimicarb in or on the following food commodities: PP 2E6388 proposed
to establish a tolerance for asparagus at 0.01 parts per million (ppm).
PP 2E6509 proposed to establish a tolerance for leafy petioles subgroup
at 1.0 ppm. PP 0E6102 proposed to establish a tolerance for hops at 4.0
ppm. On May 30, 2008, IR-4 notified EPA that it was withdrawing these
three petitions.

B. PP 1E6427 (iprodione)

    EPA issued a notice in the Federal Register of August 2, 2006 (71
FR 43760) (FRL-8082-8), which announced the submission of a pesticide
petition (PP 1E6427) (EPA-HQ-OPP-2006-0637) by IR-4. This petition
requested that EPA amend 40 CFR 180.399 by establishing tolerances for
residues of the fungicide iprodione [3-(3,5-dichlorophenyl)-N-(1-
methylethyl)-2,4-dioxo-1-imidazolidinecarboxamide, its isomer 3-(1-
methylethyl)-N-(3,5-dichlorophenyl)-2,4-dioxo-1-
imidazolidinecarboxamide, and its metabolite 3-(3,5-dichlorophenyl)-
2,4-dioxo-1-imidazolidinecarboxamide in or on the food commodity
pistachio at 0.20 ppm. On July 9, 2008, IR-4 notified EPA that it was
withdrawing this petition.

C. PP 4E6868 (amides)

    EPA issued a notice in the Federal Register of December 9, 2004 (69
FR 71405) (FRL-7687-8), which announced the submission of a pesticide
petition (PP 4E6868) (EPA-HQ-OPP-2004-0386) by Cognis Corporation, 4900
Este Avenue, Cincinnati, OH 45234. This petition proposed that EPA
amend 40 CFR 180.960 by establishing an exemption from the requirement
of a tolerance for residues of amides, from acetic acid, C5-9
carboxylic acids and diethylenetriamine-ethyleneimine polymer (CAS Reg.
No. 192230-19-6) in or on all raw agricultural commodities when used as
an inert ingredient in the pesticide formulations. On March 22, 2005,
Cognis Corporation notified EPA that it was withdrawing this petition.

D. PP 5E7013 (boscalid)

    EPA issued a notice in the Federal Register of June 14, 2006 (71 FR
34342) (FRL-8070-8), which announced the submission of a pesticide
petition (PP 5E7013) (EPA-HQ-OPP-2005-0145) by IR-4. This petition
requested that EPA amend 40 CFR 180.589 by establishing tolerances for
residues of the fungicide boscalid; 3-pyridinecarboxamide, 2-chloro-N-
(4'-chloro(1,1'-biphenyl)-2-yl) in or on the food commoditiy Belgian
endive at 12.0 ppm. IR-4 additionally proposed to increase the
established tolerances for boscalid in or on the raw agricultural
commodities: Fruit, pome, crop group 11, to include postharvest use at
8.0 ppm; and fruit, stone, crop group 12, to include postharvest use,
at 9.0 ppm. On January 3, 2007, IR-4 notified EPA that it was
withdrawing the post-harvest uses of boscalid on Fruit, pome, crop
group 11 and Fruit, Stone, crop group 12 from this petition. On March
27, 2008, IR-4 notified EPA that it was withdrawing the endive, Belgian
tolerance from this petition; thereby withdrawing the entire petition.

E. PP 5E7014 (pyraclostrobin)

    EPA issued a notice in the Federal Register of July 5, 2006 (71 FR
38150) (FRL-8074-2), which announced the submission of a pesticide
petition (PP 5E7014) (EPA-HQ-OPP-2006-0522) by IR-4. This petition
requested that EPA amend 40 CFR 180.582 by establishing tolerances for
residues of the fungicide, pyraclostrobin, carbamic acid, [2-[[[1-(4-
chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester
and its metabolite methyl-N-[[[1-(4-chlorophenyl) pyrazol-
3yl]oxy]otolyl]carbamate (BF 500-3); expressed as parent compound in or
on food commodities: Endive, Belgian, at 11 ppm; fruit, pome, group 11,
at 6.5 ppm; and fruit, stone, group 12 at 11 ppm. On January 3, 2007,
IR-4 notified EPA that it was withdrawing the postharvest uses of
pyraclostrobin on fruit, pome, crop group 11 and fruit, ftone, crop
group 12 from this petition. On March 27, 2008, IR-4 notified EPA that
it was withdrawing the endive, Belgian tolerance from this petition;
thereby withdrawing the entire petition.

F. PP 5F7018 (mefenoxam)

    EPA issued a notice in the Federal Register of June 21, 2007 (71 FR
35671) (FRL-8063-8), which announced the submission of a pesticide
petition (PP 5F7018) (EPA-HQ-OPP-2006-0096) by Syngenta Crop
Protection, P.O. Box 18300, Greensboro, NC 27409. This petition
requested that EPA amend 40 CFR 180.546 by establishing a regional

tolerance (East of the Mississippi River) for residues of the fungicide
mefenoxam in or on food commodities bean, succulent shelled at 0.03
ppm; and a national tolerance in or on food commodities turnip, greens
at 5.0 ppm. On December 3, 2007, Syngenta Crop Protection notified EPA
that it was withdrawing the petition.

G. PP 6E7047; PP 6E7048 (propyzamide; pronamide)

    EPA issued a notice in the Federal Register of May 9, 2007 (72 FR
26375) (FRL-8128-1), which announced the submission of pesticide
petitions (PP 6E7074 and PP 6E7075) (EPA-HQ-OPP-2007-0189) by IR-4.
These petitions requested that EPA amend 40 CFR 180.317 by establishing
tolerances for residues of the herbicide propyzamide (pronamide) and
its metabolite containing the 3,5-dichlorobenzoyl moiety and calculated
as 3,5-dichloro-N-(1,1-dimethyl-2-propynyl) benzamide in or on food
commodities: Chicory roots at 0.2 ppm; chicory tops at 2.0 ppm; endive,
Belgium at 2.0 ppm; and dandelion, leaves at 2.0 ppm (PP 6E7047); and
Berry group 13 at 0.05 ppm (PP 6E7048). On March 10, 2008, IR-4
notified EPA that it was withdrawing the petitions.

H. PP 6E7056 (pirimiphos-methyl)

    EPA issued a notice in the Federal Register of May 10, 2006 (71 FR
27245) (FRL-8067-7), which announced the submission of a pesticide
petition (PP 6E7056) (EPA-HQ-OPP-2006-0334) by IR-4. This petition
requested that EPA amend 40 CFR 180.409 by establishing tolerances for
residues of the insecticide pirimiphos-methyl in or on sunflower seeds
at 10 ppm. On January 30, 2008, IR-4 notified EPA that it was
withdrawing the petition.

I. PP 6E7164 (boscalid)

    EPA issued a notice in the Federal Register of April 4, 2007 (72 FR
16352) (FRL-8119-2), which announced the submission of a pesticide
petition (PP 6E7164) (EPA-HQ-OPP-2007-0115) by IR-4. This petition
requested that EPA amend 40 CFR 180.589 by establishing tolerances for
residues of the fungicide boscalid, (BAS 510F), 3-pyridinecarboxamide,
2-chloro-N-(4'-chloro(1,1'-biphenyl)-2-yl) in or on food commodities
avocado at 1.5 ppm; sapote, black at 1.5 ppm; canistel at 1.5 ppm;
sopote, mamey at 1.5 ppm; mango at 1.5 ppm; papaya at 1.5 ppm;
sapodilla at 1.5 ppm; star apple at 1.5 ppm; and herbs, fresh, subgroup
19A at 60.0 ppm. On February 6, 2008, IR-4 notified EPA that it was
withdrawing the Herbs, fresh, subgroup 19A tolerance from this
petition.

J. PP 6E7165 (pyraclostrobin)

    EPA issued a notice in the Federal Register of April 4, 2007 (72 FR
16352) (FRL-8119-2), which announced the submission of a pesticide
petition (PP 6E7165) (EPA-HQ-OPP-2007-0117) by IR-4. This petition
requested that EPA amend 40 CFR 180.582 by establishing tolerances for
residues of the fungicide pyraclostrobin, (carbamic acid, [2-[[[1-(4-
chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenyl]methoxy-,methyl ester)
and its metabolite (methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-
tolyl] carbamate) (BF 500-3) expressed as parent compound in or on the
food commodities: Herbs, fresh, subgroup 19A at 30.0 ppm; avocado at
0.7 ppm; mango at 0.7 ppm; papaya at 0.7 ppm; sapote, black at 0.7 ppm;
sapote, mamey at 0.7 ppm; canistel at 0.7 ppm; sapodilla at 0.7 ppm;
and star apple at 0.7 ppm. On February 6, 2008, IR-4 notified EPA that
it was withdrawing the Herbs, fresh, subgroup 19A tolerance from this
petition.

K. PP 7E7213 (thiobencarb)

    EPA issued a notice in the Federal Register of August 22,2007 (72
FR 47010) (FRL- 8142-5), which announced the submission of pesticide
petition (PP 7E7213) (EPA-HQ-OPP-2007-0472) by IR-4. This petition
requested that EPA amend 40 CFR 180.401 by establishing tolerances for
residues of the of the herbicide thiobencarb, (S-[(4-
chlorophenyl)methyl]diethyl-carbamothioate) and its chlorobenzyl and
chlorophenyl moiety-containing metabolites in or on food commodity
rice, wild at 0.2 ppm. On December 19, 2008, IR-4 notified EPA that it
was withdrawing this petition.

L. PP 7E7309 (1,2-benzisothiazolin-3-one)

    EPA issued a notice in the Federal Register of February 6, 2008 (73
FR 6964) (FRL-8350-9), which announced the submission of a pesticide
petition (PP 7E7309) (EPA-HQ-OPP-2008-0044) by Syngenta Crop
Protection, P.O. Box 18300, Greensboro, NC 27409. This petition
requested that EPA amend 40 CFR part 180 by establishing an exemption
from the requirement of a tolerance under 40 CFR 180.910 for residues
of 1,2-benzisothiazolin-3-one (BIT) as an inert ingredient in post-
harvest applications at a maximum of 0.1% in an end-use product
formulation. On October 31, 2008, Syngenta Crop Protection, notified
EPA that it was withdrawing this petition.

M. PP 7E7238 (propyzamide; pronamide)

    EPA issued a notice in the Federal Register of October 24, 2007 (72
FR 60369) (FRL-8150-8), which announced the submission of a pesticide
petition (PP 7E7238) (EPA-HQ-OPP-2007-0189) by IR-4. This petition
requested that EPA amend 40 CFR 180.317 by establishing tolerances for
residues of the herbicide propyzamide (pronamide) and its metabolite
containing the 3,5-dichlorobenzoyl moiety calculated as 3,5-dichloro-N-
(1,1-dimethyl-2-propynyl) benzamide in or on food commodities bearberry
at 1.0 ppm; bilberry at 1.0 ppm; blueberry, lowbush at 1.0 ppm;
cloudberry at 1.0 ppm; cranberry at 1.0 ppm; lingonberry at 1.0 ppm;
muntries at 1.0 ppm; and partridgeberry at 1.0 ppm. On September 26,
2008, IR-4 notified EPA that it was withdrawing this petition.

N. PP 7F7295 (fludioxonil)

    EPA issued a notice in the Federal Register of July 9, 2008 (73 FR
39289) (FRL-8371-2), which announced the submission of a pesticide
petition (PP 7F7295) (EPA-HQ-OPP-2008-0490) by Syngenta Crop
Protection, Inc.. This petition requested that EPA amend 40 CFR 180.516
by establishing a tolerance for residues of the fungicide fludioxonil,
4-(2, 2-difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile, in or
on food commodity raisins at 1.9 ppm. On December 3, 2008, Syngenta
Crop Protection, Inc. notified EPA that it was withdrawing the
petition.

O. PP 9E5075 (esfenvalerate)

    EPA issued a notice in the Federal Register of September 13, 2006
(71 FR 54060) (FRL-8091-1), which announced the submission of a
pesticide petition (PP 9E5075) (EPA-HQ-OPP-2006-0730) by IR-4. This
petition requested that EPA amend 40 CFR 180.533 by establishing
tolerances for residues of the insecticide esfenvalerate, ((S)-cyano-
(3-phenoxyphenyl)methyl(S)-4-chloroalpha-(1-methylethyl)
benzeneacetate) in or on oilseed crops; rapeseed (canola), seed; indian
rapeseed; Indian mustard, seed; field mustard, seed; black mustard,
seed; flax, seed; sunflower, seed; safflower, seed; borage, seed; and
crambe at 0.3 ppm. On November 13, 2008, IR-4 notified EPA that it was
withdrawing the petition.

III. Regulatory Assessment Requirements

    This action provides notice that various tolerance petitioners have
withdrawn, partially or completely, their petitions to establish
tolerances. Under 40 CFR 180.8, petitioners are

authorized to take such action. Because EPA is merely providing notice
of actions of outside parties, the regulatory assessment requirements
imposed on rulemaking do not apply to this action.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 3, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E9-6002 Filed 3-24-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Rules and Regulations]
[Pages 41662-41665]
[FR Doc No: 2011-17421]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0695; Directorate Identifier 2011-SW-001-AD;
Amendment 39-16740; AD 2011-14-05]
RIN 2120-AA64

Airworthiness Directives; MD Helicopters, Inc. Model MD900
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: This amendment supersedes an existing airworthiness directive
(AD) for MD Helicopters, Inc. (MDHI) Model MD900 helicopters. That AD
currently requires visually inspecting the main rotor lower hub
assembly (lower hub) for a crack, and if you find a crack, before
further flight, replacing the unairworthy lower hub with an airworthy
lower hub. Additionally, within 10 days of finding a cracked lower hub,
the existing AD requires reporting the finding to the Los Angeles
Aircraft Certification Office (LAACO). That AD was prompted by two
reports of cracks detected in the hub in the area near the flex beam
bolt hole locations during maintenance on two MDHI Model MD900
helicopters. Since we issued that AD, we determined that one
manufacturer had incorrectly inserted flanged bushings into the lower
hub bore that resulted in local corrosion, leading to fatigue cracking.
Examination of lower hubs from the other manufacturer shows correct
bushing installation. Therefore, this amendment limits the
applicability to the affected lower hubs; retains the visual inspection
but at a different compliance time; adds an eddy current inspection;
retains the requirement to replace a cracked lower hub with an
airworthy lower hub before further flight; and removes the requirement
to report to the LAACO. The actions specified by this AD are intended
to detect a crack in the lower hub and prevent failure of the lower hub
and subsequent loss of control of the helicopter.

DATES: This AD is effective August 1, 2011.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of August 1,
2011.
    We must receive any comments on this AD by September 13, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact MD
Helicopters Inc., Attn: Customer Support Division, 4555 E. McDowell
Rd., Mail Stop M615, Mesa, AZ 85215-9734, telephone 1-800-388-3378, fax
480-346-6813, or at http://www.mdhelicopters.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Eric Schrieber, Aviation Safety
Engineer, FAA, Los Angeles Aircraft Certification Office, Airframe
Branch, 3960 Paramount Blvd., Lakewood, California 90712-4137,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    On August 19, 2010, we issued Emergency AD (EAD) 2010-18-51. That
EAD was prompted by two reports of cracks detected in the lower hub
near the flex beam bolt hole location during maintenance. That EAD
required, within 4 hours time-in-service (TIS), visually inspecting the
lower hub for a crack and, if you find a crack, before further flight,
replacing the lower hub with an airworthy lower hub and, within 10
days, reporting a cracked lower hub to the LAACO. We superseded EAD
2010-18-51 with EAD 2010-18-52, issued August 23, 2010, upon
discovering a typographical error in the ``Applicability'' section of
the EAD in the lower hub part number (P/N). EAD 2010-18-52 contained
the same requirements as EAD 2010-18-51 but corrected the P/N for the
lower hub.

Actions Since That AD Was Issued

    Since we issued the AD, 5 additional lower hubs were found cracked.
We determined that one manufacturer of lower hubs with serial numbers
(S/Ns) beginning with 5009 (e.g., 5009-XXXX) had incorrectly inserted
flanged bushings into the lower hub bore. This condition resulted in
local corrosion leading to fatigue cracking. Examination of lower hubs
from the other manufacturer shows correct bushing installation.

Relevant Service Information

    We reviewed MDHI Service Bulletin SB900-117, dated January 14, 2011
(SB). The SB specifies an initial 100-hour and recurring 300-hour
visual and eddy current inspections of the lower hub for a crack and,
if there is a crack, replacing the lower hub with an airworthy lower
hub. The inspections would be done at the stated intervals or at the
next annual inspection, whichever occurs first. The SB also specifies
replacing an affected lower hub within 3 years after the date of the
SB.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other helicopters of this same type
design.

AD Requirements

    This AD requires a visual inspection, and if necessary, an eddy
current inspection of the lower hub for a crack. If there is a crack,
the AD requires replacing the lower hub with an airworthy lower hub.
This AD requires accomplishing these actions by following specified
portions of the service information described previously, except as
discussed under ``Differences Between the AD and the Service
Information.''

Change to Existing AD

    This superseding AD changes the compliance time for the visual
inspection and adds an eddy current inspection of the lower hub for a
crack. This AD also removes the reporting requirement to the LAACO and
the requirement for an OMB control number. This AD also reduces the
applicability to only those helicopters with certain serial-numbered
lower hubs installed.

Differences Between the AD and the Service Information

    This AD does not require contacting the manufacturer or returning
the lower hub assembly with a certain report. This AD also does not
require the 300-hour inspection or replacing the lower hub within 3
years from the date of the SB because these actions do not fit our
criteria for a Final rule, request for comments.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because the
previously described unsafe condition can adversely affect the
structural integrity and controllability of the helicopter. The
inspection is required within 100 hours TIS or during the annual
inspection, whichever occurs first, unless done within the last 200
hours TIS. Since the affected helicopters could reach 100 hours TIS
within 1 month, we find that notice and opportunity for prior public
comment are impracticable and that good cause exists for making this
amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
the docket number FAA-2011-0695 and directorate identifier 2011-SW-001-
AD at the beginning of your comments. We specifically invite comments
on the overall regulatory, economic, environmental, and energy aspects
of this AD. We will consider all comments received by the closing date
and may amend this AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 12 helicopters of U.S. registry.
We estimate the following costs to comply with this AD:

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                Action                          Labor cost                          Parts cost                      product      Cost on U.S. operators
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 work hour to visually inspect the     1 work-hour x $85 per      N/A........................................             $85  $1,020.
 hub.                                    hour = $85.

1 work hour to eddy current inspect     1 work-hour x $85 per      N/A........................................             $85  $1,020.
 the lower hub [new action].             hour = $85.
Required parts and labor to replace a   11 work hours x 85 per     $12,480 per hub............................         $13,415  $160,980.
 lower hub.                              hour = $935.
                                       -----------------------------------------------------------------------------------------------------------------
    Total.............................  $1,105...................  $12,480....................................         $13,585  $163,020 assuming the
                                                                                lower hubs are replaced
                                                                                for the entire fleet.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends part 39 of the Federal Aviation
Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2010-18-52, Amendment 39-16515 (75 FR 69862, November 16, 2010) and
adding the following new AD:

2011-14-05 MD HELICOPTERS, INC.: Amendment 39-16740; Docket No. FAA-
2011-0695; Directorate Identifier 2011-SW-001-AD.

Effective Date

    (a) This AD is effective August 1, 2011.

Affected ADs

    (b) This AD supersedes AD 2010-18-52, Amendment 39-16515, Docket
No. FAA-2010-1126; Directorate Identifier 2010-SW-078-AD.

Applicability

    (c) Model MD900 helicopters with main rotor lower hub assembly
(lower hub), part number (P/N) 900R2101008-107, serial numbers (S/
Ns) that begin with 5009, certificated in any category.

Unsafe Condition

    (d) This amendment is prompted by the determination that a
certain manufacturer had incorrectly inserted the flanged bushings
into the lower hub bore. The actions specified by this AD are
intended to detect a crack in the lower hub and prevent failure of
the hub and subsequent loss of control of the helicopter.

Compliance

    (e) Within 100 hours time-in-service (TIS) or during the next
annual inspection, whichever occurs first, unless done within the
last 200 hours TIS:
    (1) Visually inspect the sides and bottom of the area between
the arms for the centering bearing and the areas adjacent to the
bushings of the lower hub assembly for a crack. If there is a crack,
before further flight, replace the lower hub with an airworthy lower
hub.
    (2) If the lower hub is not replaced as a result of the visual
inspection required by paragraph (e)(1) of this AD, eddy current
inspect the lower hub for a crack by following the Accomplishment
Instructions, paragraphs 2.A(2) through 2.A.(10)., of MD Helicopters
Inc. Service Bulletin SB900-117, dated January 14, 2011 (SB). If
there is a crack, before further flight, replace the lower hub with
an airworthy hub.
    (f) The eddy current inspection required by paragraph (e)(2) of
this AD must be done by a Level II technician with ASNT-TC-1A, CEN
EN 4179, MIL-STD-410, NAS410, or equivalent certification in eddy
current inspections. The technician must have done an eddy current
inspection in the last 12 months.

Alternative Methods of Compliance (AMOCs)

    (g)(1) The Manager, Los Angeles Aircraft Certification Office
(LAACO), FAA, has the authority to approve AMOCs for this AD, if
requested, using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the LAACO, send it to the
attention of the person identified in the Additional Information
section of this AD.
    (2) Before using any approved AMOC, we request that you notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office.

Additional Information

    (h) For more information about this AD, contact Eric Schrieber,
Aviation Safety Engineer, FAA, Los Angeles Aircraft Certification
Office, Airframe Branch, 3960 Paramount Blvd., Lakewood, California
90712-4137, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

Material Incorporated by Reference

    (i)(1) Inspect the main rotor lower hub assembly for a crack by
following the specified portions of MD Helicopter, Inc. Service
Bulletin SB 900-117, dated January

14, 2011. The Director of the Federal Register approved the
incorporation by reference of the service information, under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact MD
Helicopters Inc., Attn: Customer Support Division, 4555 E. McDowell
Rd., Mail Stop M615, Mesa, AZ 85215-9734, telephone 1-800-388-3378,
fax<PHONE_NUMBER>, or at http://www.mdhelicopters.com.
    (3) Copies may be inspected at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at an
NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Subject

    (j) The Joint Aircraft System Component (JASC)/Air Transport
Association (ATA) of America Code is 6220: Main Rotor Head.

    Issued in Fort Worth, Texas, on June 21, 2011.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2011-17421 Filed 7-14-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59258-59261]
[FR Doc No: 2021-23258]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93388; File No. SR-ICC-2021-018]

Self-Regulatory Organizations; ICE Clear Credit LLC; Order
Approving Proposed Rule Change Relating to the ICC Back-Testing
Framework

October 20, 2021.

I. Introduction

    On August 24, 2021, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act''),\1\
and Rule 19b-4 thereunder,\2\ a proposed rule change (SR-ICC-2021-018)
to revise the ICE CDS Clearing: Back-Testing Framework (``Back-Testing
Framework'') to include additional description on the lookback period
for back-testing and other

clarifications.\3\ The proposed rule change was published in the
Federal Register on September 14, 2021.\4\ The Commission did not
receive comments on the proposed rule change. For the reasons discussed
below, the Commission is approving the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Capitalized terms used herein but not otherwise defined have
the meaning set forth in the ICC Rules or the Back-Testing
Framework.
    \4\ Self-Regulatory Organizations; ICE Clear Credit LLC; Notice
of Filing of Proposed Rule Change Relating to the ICC Back-Testing
Framework, Exchange Act Release No. 92893 (Sept. 8, 2021); 86 FR
51204 (Sept. 14, 2021) (SR-ICC-2021-018) (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The Back-Testing Framework discusses ICC's back-testing approach
and analysis to verify that the number of actual losses is consistent
with the number of projected losses, and includes guidelines for
remediating poor back-testing results. ICC proposes revising the Back-
Testing Framework to include additional description on the lookback
period for back-testing, which refers to the maximum back-testing
sample size, and other clarifications. The proposed revisions to the
Back-Testing Framework are described in detail as follows.\5\
---------------------------------------------------------------------------

    \5\ The following description of the proposed rule change is
substantially excerpted from the Notice.
---------------------------------------------------------------------------

    ICC proposes a clarification change in Subsection 1.2 to specify
that the ICC Risk Management Department (``ICC Risk'') may consider
back-testing analysis based on alternative statistical tests to assess
the performance of its models in terms of statistical reliability, in
addition to its current consideration of clustering of exceedances,
which refers to excessive losses.
    ICC proposes new Subsection 2.1 (Lookback Period for Back-Testing
of the Production Model with Clearing Participant Portfolios) to
include additional description of the lookback period for back-testing,
which refers to the maximum back-testing sample size. ICC represents
that proposed Subsection 2.1 would not change its methodology.\6\
Specifically, proposed Subsection 2.1 defines back-testing as
statistics-based hypothesis testing, and clarifies that the larger the
sample size is, the more reliable the inference is from such testing.
Proposed Subsection 2.1 describes the performance of production model
back-testing analysis for Clearing Participant (``CP'') related
portfolios reflecting all available observations over periods of
various market conditions. The proposed language also describes the
maximum back-testing sample size, or the lookback period, and the
benefit of allowing for a greater sample size that would incorporate
observations from various market regimes to assess model performance
and thus ensure more reliable inferences from back-testing. The
proposed language also analyzes short lookback periods, which may
exclude extreme stress market conditions, in combination with high risk
quantile estimates (e.g., greater than 99%). ICC also proposes to
introduce an alternative statistical test and describe how the model is
considered to pass or fail such test. Proposed Figure 1 provides an
illustration under the alternative statistical test across different
sample sizes and risk quantiles. Following proposed Figure 1, ICC would
explain its rationale for establishing the minimum back-testing window
length for the initial margin risk horizon, or the Margin Period of
Risk (``MPOR'') model analysis. Proposed Subsection 2.1 also references
the performance of additional analyses, as described in Section 4 of
the Back-Testing Framework which contain guidelines to remediate poor
back-testing results. Proposed Subsection 2.1 includes language
concerning the reporting of back-testing results for portfolios,
including those with an insufficient number of observations. Given the
proposed addition of new Subsection 2.1, ICC proposes to renumber the
subsequent subsections of the Back-Testing Framework document.
---------------------------------------------------------------------------

    \6\ See Notice at 51205.
---------------------------------------------------------------------------

    ICC proposes additional clarifications to the Back-Testing
Framework. The proposed amendments include a footnote in amended
Subsection 2.6 (BTLS Exceedance Summaries) that references a relevant
Commodity Futures Trading Commission (``CFTC'') regulation with respect
to ICC's performance of production model 99% back-testing analysis for
all CP related portfolios. ICC also proposes amendments to Section 4
(Guidelines to Remediate Poor Back-Testing Results). Currently, poor
back-testing results require a peer review of the risk models by the
Risk Working Group (``RWG''), which is comprised of risk
representatives from ICC's CPs, and remedial actions to improve model
performance. Section 4 currently states that model performance analysis
along with the model assumptions are presented to the RWG for review
and discussions. In addition to the model assumptions, the proposed
change would include the number of observations for the RWG's review
and discussions. Section 4 also currently states that a back-testing
analysis without overlapping periods will be performed in order to
confirm poor-backing results if the number of observed exceedances
falls in the ``red zone'' of the so-called Basel Traffic Light System
(BTLS) of the Basel Committee Supervisory Framework. The proposed rule
change would amend such statement to include the RWG's assessment of
the sufficiency of the number of observations in performing the
portfolio-level back-testing analysis, thus supplementing the current
complementary back-testing analysis without overlapping periods. ICC
also proposes to update Section 5, containing a list of references, to
include a reference to the alternative statistical test described above
in the proposed new Subsection 2.1.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\7\ For the reasons given below, the Commission finds that
the proposal is consistent with Section 17A(b)(3)(F) of the Act \8\ and
Rules 17Ad-22(e)(2)(i) and (v), and 17Ad-22(e)(6)(vi) thereunder.\9\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2)(C).
    \8\ 15 U.S.C. 78q-1(b)(3)(F).
    \9\ 17 CFR 240.17Ad-22(e)(2)(i) and (v), and (e)(6)(vi).
---------------------------------------------------------------------------

A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of ICC be designed to promote the prompt and accurate
clearance and settlement of securities transactions and, to the extent
applicable, derivative agreements, contracts, and transactions, as well
as to assure the safeguarding of securities and funds which are in the
custody or control of ICC or for which it is responsible.\10\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    As discussed above, the proposed rule change would revise the Back-
Testing Framework to include additional description of the lookback
period for back-testing and other clarifications. For the specific
reasons discussed below, the Commission believes that, in general, the
proposed rule change would help ensure the sound operation of the Back-
Testing Framework that should enhance the overall risk management and
financial stability of ICC, and thereby promote ICC's prompt and
accurate clearance and settlement of

credit default swap (``CDS'') transactions, and help assure the
safeguarding of securities and funds which are in ICC's custody or
control or for which ICC is responsible.
    First, the Commission believes that the proposed clarification in
Subsection 1.2, in specifying that ICC Risk may use alternative
statistical tests to assess the performance of its risk models for
statistical reliability, would strengthen its back-testing approach and
analysis by supplementing its consideration of the clustering of
exceedances or excessive losses.
    Second, as discussed above, the proposed rule change also would
introduce a new Subsection 2.1 that provides additional detail and
explanation regarding the lookback period for its back-testing analysis
methodology. Specifically, the Commission believes that proposed
Subsection 2.1, in clarifying that back-testing is statistics-based
hypothesis testing and that a larger sample size enhances the
reliability of the inferences from such testing, would establish a
clear risk management rationale for ICC's methodology to assess the
performance of production model back-testing analysis for CP related
portfolios reflecting all available observations over periods of
various market conditions. The Commission also believes that proposed
Subsection 2.1, in analyzing short lookback periods and describing in
detail an alternative statistical test by illustrating its application
across different sample sizes and risk quantiles, would provide a
transparent, risk-based explanation for setting the minimum back-
testing window length for ICC's MPOR model analysis. The Commission
also believes that proposed Subsection 2.1, in referencing additional
analyses described in Section 4 (Guidelines to Remediate Poor Back-
Testing Results), and describing the reporting of back-testing results
for portfolios, including those with an insufficient number of
observations, would enhance the clarity and transparency of ICC's back-
testing procedures and contribute to the effective implementation of
its overall back-testing approach. The Commission also believes that
the proposed renumbering of sections that follow proposed new
Subsection 2.1 will provide further clarity and enhance the readability
of the Back-Testing Framework document.
    Third, as discussed above, ICC proposes additional clarifications
to the Back-Testing Framework that the Commission believes, taken
together, will enhance the clarity of its back-testing approach,
procedures, and guidelines for remediating poor back-testing results.
Specifically, the proposed amendments to Subsection 2.6 (BTLS
Exceedance Summaries), in clearly referencing a relevant CFTC
regulation with respect to ICC's performance of production model 99%
back-testing analysis for all CP related portfolios, would help assure
continued compliance with such regulation. The proposed amendments to
Section 4 (Guidelines to Remediate Poor Back-Testing Results), in
specifying that the RWG will review and discuss the number of
observations in conducting its risk model performance analysis, and
also assess the sufficiency of the number of observations on the
portfolio level back-testing analysis without overlapping periods,
would strengthen the RWG's analysis and better inform remedial actions.
Finally, the proposed amendment to Section 5, in including a clear
reference to the alternative statistical test described above in the
proposed new Subsection 2.1, would assure that the RWG and relevant ICC
Risk personnel have access to further details in using such test.
    By helping to assure the sound operation of the Back-Testing
Framework, which ICC uses to manage the credit exposures associated
with clearing CDS transactions, the Commission believes that the
proposed rule change would help improve ICC's ability to avoid the
losses that could result from the miscalculation of ICC's credit
exposures and margin requirements for such transactions. Because such
losses could disrupt ICC's ability to operate and thus clear and settle
CDS transactions, the Commission finds the proposed rule change, by
helping to enhance ICC's overall risk management and financial
stability, would promote the prompt and accurate clearance and
settlement of securities and derivative transactions. Because such
losses could also threaten access to securities and funds in ICC's
control, the Commission finds the proposed rule change would help
assure the safeguarding of securities and funds that are in the custody
or control of ICC or for which it is responsible.
    Therefore, the Commission finds that the proposed rule change would
promote the prompt and accurate clearance and settlement of securities
transactions and derivative agreements, contracts, and transactions,
and assure the safeguarding of securities and funds in ICC's custody
and control or for which ICC is responsible, consistent with Section
17A(b)(3)(F) of the Act.\11\
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    \11\ 15 U.S.C. 78q-1(b)(3)(F).
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B. Consistency With Rules 17Ad-22(e)(2)(i) and (v) Under the Act

    Rules 17Ad-22(e)(2)(i) and (v) require that ICC establish,
implement, maintain, and enforce written policies and procedures
reasonably designed to provide for governance arrangements that are
clear and transparent and specify clear and direct lines of
responsibility, respectively.\12\ As discussed above, the Commission
believes that the proposed rule change, in specifying that ICC Risk may
use alternative statistical tests to assess the performance of its risk
models for statistical reliability, would provide ICC Risk with
procedural clarity in conducting its back-testing analysis of risk
models. The Commission believes that the proposed amendments in Section
4, in specifying that the RWG will review and discuss the number of
observations in conducting its risk model performance analysis, and
also assess the sufficiency of the number of observations on the
portfolio level back-testing analysis without overlapping periods,
would clarify the scope of the RWG's responsibility in reviewing poor
back-testing results and would help the RWG to take more fully informed
remedial actions, such as making risk model enhancements or introducing
ad-hoc parameter values to achieve an increased conservative bias of
the risk models. Finally, the proposed amendment to Section 5, in
including a clear reference to the alternative statistical test
described above in the proposed new Subsection 2.1, would assure that
the RWG and relevant ICC Risk personnel have the correct source
document to govern the ongoing use of such test for verifying the
accuracy of risk management models.
---------------------------------------------------------------------------

    \12\ 17 CFR 240.17Ad-22(e)(2)(i) and (v).
---------------------------------------------------------------------------

    The Commission believes that these aspects of proposed rule change
would clearly assign and document the respective roles and
responsibilities of ICC Risk and the RWG in implementing the Back-
Testing Framework, and thereby improving the related governance
arrangements for performing the appropriate scope of back-testing
analysis and taking remedial actions if poor back-testing results
warrant such action. The Commission therefore finds that the proposed
rule change is consistent with Rules 17Ad-22(e)(2)(i) and (v).\13\
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    \13\ 17 CFR 240.17Ad-22(e)(2)(i) and (v).
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C. Consistency With Rule 17Ad-22(e)(6)(vi) Under the Act

    Rule 17Ad-22(e)(6)(vi) requires that ICC establish, implement,
maintain and enforce written policies and procedures

reasonably designed to cover its credit exposures to its participants
by establishing a risk-based margin system that, at a minimum, is
monitored by management on an ongoing basis and is regularly reviewed,
tested, and verified by, among other things: (A) Conducting backtests
of its margin model at least once each day using standard predetermined
parameters and assumptions; and (B) conducting a sensitivity analysis
of its margin model and a review of its parameters and assumptions for
backtesting on at least a monthly basis, and considering modifications
to ensure the backtesting practices are appropriate for determining the
adequacy of ICC's margin resources.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 240.17Ad-22(e)(6)(vi).
---------------------------------------------------------------------------

    Consistent with such back-testing requirements, the proposed rule
change would not modify ICC Risk's current back-testing practices of
performing daily, weekly, monthly, and quarterly portfolio-level back-
testing analyses, performing monthly parameter reviews and parameter
sensitivity analyses, and remediating poor back-testing results under
the Back-Testing Framework.\15\ For the reasons discussed below, the
Commission finds that the proposed rule change would enhance such back-
testing practices to help ICC monitor its credit exposures to its
clearing participants and maintain the ongoing effectiveness of its
risk-based margin system and overall risk management framework. As
described above, proposed new Subsection 2.1 (Lookback Period for Back-
Testing of the Production Model with Clearing Participant Portfolios),
in adding a detailed description of the maximum back-testing sample
size, or lookback period, and an alternative statistical test for
enhanced analysis and verification of the accuracy of risk model
performance, would clarify and strengthen ICC's back-testing analysis
for CP related portfolios. Proposed Subsection 2.1, in establishing the
minimum back-testing window length for the Margin Period of Risk (MPOR)
model analysis, subjecting the MPOR model to the performance of
additional analyses for portfolios with an insufficient number of
available observations, and clarifying the reporting of back-testing
results for such portfolios, would help ensure that the back-testing
practices for MPOR models are appropriate for determining the accuracy
of ICC's margin resources. If red-zone results appear from overlapping
back-testing periods, Section 4, as amended, would require ICC Risk to
assess the sufficiency of the number of observations on the portfolio-
level back-testing analysis, which would supplement its complementary
back-testing analysis without overlapping periods. The Commission
therefore finds that these aspects of the proposed rule change, taken
together, are consistent with Rule 17Ad-22(e)(6)(vi).\16\
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    \15\ See Notice at 51205.
    \16\ 17 CFR 240.17Ad-22(e)(6)(vi).
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IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act, and in
particular, with the requirements of Section 17A(b)(3)(F) of the Act
\17\ and Rules 17Ad-22(e)(2)(i) and (v), and 17Ad-22(e)(6)(vi)
thereunder.\18\
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    \17\ 15 U.S.C. 78q-1(b)(3)(F).
    \18\ 17 CFR 240.17Ad-22(e)(2)(i) and (v), and (e)(6)(vi).
---------------------------------------------------------------------------

    It is therefore ordered pursuant to Section 19(b)(2) of the Act
\19\ that the proposed rule change (SR-ICC-2021-018) be, and hereby is,
approved.\20\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(2).
    \20\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).
    \21\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-23258 Filed 10-25-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60215-60217]
[FR Doc No: 2023-18841]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1214]

Considerations for the Use of Real-World Data and Real-World
Evidence To Support Regulatory Decision-Making for Drug and Biological
Products; Guidance for Industry; 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 a final guidance for industry entitled
``Considerations for the Use of Real-World Data and Real-World Evidence
to Support Regulatory Decision-Making for Drug and Biological
Products.'' FDA is issuing this guidance as part of its Real-World
Evidence (RWE) Program for drugs and to satisfy, in part, the mandate
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue
guidance about the use of RWE in regulatory decision making. This
guidance discusses the applicability of FDA's investigational new drug
application (IND) regulations to various clinical study designs that
utilize real-world data (RWD) and clarifies the Agency's expectations
regarding clinical studies using RWD submitted to FDA in support of a
regulatory decision regarding the effectiveness or safety of a drug
that are not subject to the IND regulations. This guidance finalizes
the draft guidance of the same title issued on December 9, 2021.

DATES: The announcement of the guidance is published in the Federal
Register on August 31, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2021-D-1214 for ``Considerations for the Use of Real-World Data and
Real-World Evidence to Support Regulatory Decision-Making for Drug and
Biological Products.'' 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, 240-
402-7500.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3226, Silver Spring, MD 20993-0002, 301-
796-3161, [email protected]; or Anne Taylor, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Considerations for the Use of Real-World Data and Real-World
Evidence to Support Regulatory Decision-Making for Drug and Biological
Products.'' The guidance discusses the following major topics: (1)
applicability of 21 CFR part 312 to studies using RWD and (2)
regulatory considerations for non-interventional (observational)
studies involving the use of RWD. Regulatory considerations addressed
by the guidance include the following: (1) transparency for data
collection and analysis, (2) access to RWD, (3) study monitoring, (4)
safety reporting, (5) other sponsor responsibilities, and (6) the
analysis of RWD generated from the use of a product under an emergency
use authorization (EUA) in routine practice.
    Section 3022 of the 21st Century Cures Act (Cures Act) of 2016
amended the FD&C Act to add section 505F, Utilizing Real World Evidence
(21 U.S.C. 355g), which requires FDA to issue guidance about the use of
RWE in regulatory decision-making. In addition, under the Prescription
Drug User Fee Amendments of 2017 (PDUFA VI), FDA is committed to
publish draft guidance on how RWE can contribute to the assessment of
safety and effectiveness in regulatory submissions. In 2018, FDA
created an RWE Framework and an RWE Program to evaluate the potential
use of RWE to help support the approval of a new indication for a drug
already approved under the FD&C Act or to help support or satisfy
postapproval study requirements. In late 2021, FDA utilized the RWE
Program to issue draft guidances outlining considerations for the use
of RWD and RWE in regulatory decision making to satisfy the Cures Act
mandate and the PDUFA VI commitment.
    This guidance finalizes the draft guidance of the same title issued
on December 9, 2021 (86 FR 70131). FDA considered comments received on
the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include transfer of relevant definitions
from the glossary to the text as well as additional language about data
generated in clinical practice for products used under an EUA
consistent with a mandate under the Food and Drug Omnibus Reform Act of
2022. Clarifying information was also added, including the use of
existing regulatory pathways for third parties to provide patient-level
data to FDA when a sponsor cannot submit such data to FDA through
traditional channels. In addition, editorial changes were made to
improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Considerations for the Use of Real-World
Data and Real-World Evidence to Support Regulatory Decision-Making for
Drug and Biological Products.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in
21 CFR part 11 pertaining to electronic records and signatures have
been approved under OMB control number 0910-0303. The collections of
information in 21 CFR parts 50 and 56 relating to protection of human
subjects and Institutional Review Boards have been approved under OMB
control number 0910-0130. The collections of information in 21 CFR part
310 relating to postmarketing adverse drug experience reporting have
been approved under OMB control number 0910-0230. The collections of
information in 21 CFR part 600 for general records and postmarketing
adverse experience reporting pertaining to biological products have
been approved under OMB control number 0910-0308. The collections of
information in 21 CFR parts 310, 314, and 600 pertaining to adverse
event and product experience reporting have been approved under OMB
control number 0910-0291. The collections of information in 21 CFR part
312 have been approved under OMB control number 0910-0014. The
collections of information in 21 CFR part 314 have been approved under
OMB control number 0910-0001. The collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338. The
collections of information in 21 CFR part 600 have been approved under
OMB control number 0910-0458.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18841 Filed 8-30-23; 8:45 am]
BILLING CODE 4164-01-P