v Cytec Industries Inc. Toxicology & Product Regulatory Compliance Dept. 5 Garret Mountain Plaza West Paterson, NJ 07424 OPPT Document Control Officer ( DCO) Date: December 16,2003 Mail Code 7407M Attention: Inventory Update Rule Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Dear Sir or Madam:

Cytec Industries Inc., requests EPA to exempt 2 Propenamide ( CAS# 79 06 1) from the processing and use reporting requirements in the TSCA Inventory Update Rule Amendments ( 40 CFR 710.52(~)( 4)).

In the January 7,2003, rulemaking for the Inventory Update Rule Amendments ( IURA), EPA announced that it was exempting certain specific chemical substances from reporting processing and use information for the IURA. In that rulemaking, EPA also noted that its process " allows anyone to submit a written request for EPA to consider revising the list of chemicals substances covered by this partial exemption."

Cytec Industries Inc. is requesting that 2 Propenamide ( CAS# 79 06 l), be added to the list of partially exempt chemicals contained in 40 CFR 710.46( b)( 2)( iv). In making its determination whether the partial exemption should apply to this substance, EPA should consider the following criteria for selection:

40 CFR 710.46( b)( 2)( ii)( A) 2 Propenamide ( CAS# 79 06 1) qualified for the reporting of the information described in 710.52(~)( 4)( Le. at least one site manufactured 300,000 lbs or more of the chemical) as reported in the 2002 IURsubmitted by Cytec Industries Inc.

40 CFR 710.46( b)( 2)( ii)( B),( C), ( D), ( E), ( F): The information previously provided to EPA for 2 Propenamide ( CAS## 79 06 1) under the HPV Challenge Program, found on EPA's web site at: http:// www. epa. Pov/ chemrtMnmac/ c13168tc. htm should be sufficient for EPA to make the necessary determination that 2 Propenamide ( CAS# 79 06 1) is " of low current interest", and that 2 Propenamide should be added to the list of partial reporting exemption under IURA. If you have any questions regarding this request, please contact me at 973 357 3460.

Sincerely,

Daniel P. Liebowitz Regulatory Compliance Manager, Americas Cytec Industries Inc.


[Federal Register Volume 86, Number 114 (Wednesday, June 16, 2021)]
[Rules and Regulations]
[Pages 31916-31918]
[FR Doc No: 2021-12582]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0356]
RIN 1625-AA00

Safety Zone; 4th of July Boat Parade, Savannah River, Savannah,
GA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters on the Savannah River from the Elba Island Cut Jetty
Light to the Eugene Talmage Memorial Bridge, Savannah, GA. The safety
zone is needed to protect personnel, vessels, and the marine
environment from potential hazards created by a boat parade. Entry of
vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port (COTP) Savannah or a designated
representative.

DATES: This rule is effective on July 4, 2021 from 2 p.m. through 5
p.m.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0356 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Alex McConnell, of the Marine Safety Unit Savannah
Office of Waterways Management, Coast Guard, at telephone<PHONE_NUMBER>,
extension 240, or via email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
prompt action is needed to respond to the potential safety hazards
associated with the Savannah boat parade. The Coast Guard received
initial notice of the event on April 26, 2021 regarding the event
beginning on July 4, 2021, but did not have final details to prepare a
regulation until May 25, 2021. The event would begin before the
rulemaking process would be completed. Because of the dangers posed by
the parade, a safety zone is necessary to provide for the safety of
persons, vessels, and the marine environment in the event area. It is
impracticable and contrary to the public interest to delay promulgating
this rule because the rule is necessary to protect personnel, vessels,
and the marine

environment from potential hazards created by the boat parade.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to the potential safety hazards associated with the boat
parade.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port (COTP) Savannah has determined that
potential hazards associated with the boat parade starting July 4,
2021, will be a safety concern for anyone on the Savannah River from
the Elba Island Cut Jetty Light to the Eugene Talmage Memorial Bridge,
Savannah, GA. This rule is needed to protect personnel, vessels, and
the marine environment in the navigable waters within the safety zone
while the parade is underway.

IV. Discussion of the Rule

    This rule establishes a safety zone from 2 p.m. until 5 p.m. on
July 4, 2021. The safety zone will cover all navigable waters from the
Savannah River from the Elba Island Cut Jetty Light to the Eugene
Talmage Memorial Bridge, Savannah, GA. The duration of the zone is
intended to protect personnel, vessels, and the marine environment in
these navigable waters while the bridge is being repaired. No vessel or
person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
duration, and scope of the safety zone. The safety zone is limited in
duration and size as it will be enforced for only three hours and will
cover all navigable waters from the Savannah River from the Elba Island
Cut Jetty Light to the Eugene Talmage Memorial Bridge, Savannah, GA.
The zone is limited in scope as vessels and persons seeking to transit
through the regulated area may seek authority from the COTP or a
designated representative. The Coast Guard will provide notification of
the regulated area to the local maritime community by Local Notice to
Mariners, Broadcast Notice to Mariners via VHF-FM marine channel 16,
and a Marine Safety Security Bulletin.

B. Impact on Small Entities

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting only 3 hours that will prohibit entry on the
Savannah River

from the Elba Island Cut Jetty Light to the Eugene Talmage Memorial
Bridge. It is categorically excluded from further review under
paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 1. A Record of Environmental Consideration supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add Sec.  165.T07-0356 to read as follows:

Sec.  165.T07-0356   Safety Zone; 4th of July Boat Parade, Savannah
River, Savannah, GA.

    (a) Location. The following area is a safety zone: All waters of
the Savannah River, from surface to bottom, from the Elba Island Cut
Jetty Light to the Eugene Talmage Memorial Bridge.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Savannah (COTP) in the enforcement of the safety
zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) Persons or vessels desiring to enter, transit through, anchor
in, or remain within the safety zone may contact COTP Savannah by
telephone at<PHONE_NUMBER>, or a designated representative via VHF
radio on channel 16, to request authorization. If authorization to
enter, transit through, anchor in, or remain within the regulated area
is granted by the COTP Savannah or a designated representative, all
persons and vessels receiving such authorization must comply with the
instructions of the COTP Savannah or a designated representative.
    (3) The Coast Guard will provide notice of the regulated areas by
Local Notice to Mariners, Broadcast Notice to Mariners, Marine Safety
Information Bulletins, and on-scene designated representatives.
    (d) Enforcement period. This section will be enforced from 2:00
p.m. until 5:00 p.m., on July 4, 2021.

    Dated: June 3, 2021.
S.A. Richardson,
Lieutenant Commander, U.S. Coast Guard, Acting, Captain of the Port.
[FR Doc. 2021-12582 Filed 6-15-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 86 (Monday, May 4, 2020)]
[Notices]
[Page 26516]
[FR Doc No: 2020-09394]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Drone Advisory Committee (DAC); Notice of Public Meeting

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the Drone Advisory
Committee.

DATES: The meeting will be held on June 19, 2020, between 9:00 a.m. and
4:00 p.m. Eastern Time.
    Requests to attend the meeting must be received by June 12, 2020.
    Requests for accommodations for a disability must be received by
June 5, 2020.
    Requests to submit written materials to be reviewed during the
meeting must be received no later than June 12, 2020.

ADDRESSES: The meeting will be held virtually. Members of the public
who wish to observe the meeting must RSVP by emailing
<EMAIL_ADDRESS>For copies of meeting minutes along with all
other information please visit the DAC internet website at https://www.faa.gov/uas/programs_partnerships/drone_advisory_committee/.

FOR FURTHER INFORMATION CONTACT: Gary Kolb, UAS Stakeholder & Committee
Liaison, Federal Aviation Administration, U.S. Department of
Transportation, at<EMAIL_ADDRESS>or<PHONE_NUMBER>. Any committee
related request or reasonable accommodation request should be sent to
the person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The DAC was created under the Federal Advisory Committee Act
(FACA), in accordance with Title 5 of the United States Code (5 U.S.C.
App. 2) to provide the FAA with advice on key UAS integration issues by
helping to identify challenges and prioritize improvements.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 Official Statement of the Designated Federal Officer
 Approval of the Agenda and Minutes
 Opening Remarks
 FAA Update
 Industry-Led Technical Topics
 New Business/Agenda Topics
 Closing Remarks
 Adjourn

    Additional details will be posted on the DAC internet website
address listed in the ADDRESSES section at least 5 days in advance of
the meeting.

III. Public Participation

    The meeting will be open to the public on a first-come, first-
served basis, as space is limited. Members of the public who wish to
attend in person or observe the virtual session must RSVP by emailing
the address listed in the ADDRESSES section with your name and
affiliation. The U.S. Department of Transportation is committed to
providing equal access to this meeting for all participants. If you
need alternative formats or services because of a disability, such as
sign language, interpretation, or other ancillary aids, please contact
the person listed in the FOR FURTHER INFORMATION CONTACT section.
    The FAA is not accepting oral presentations at this meeting due to
time constraints. Written statements submitted by the deadline will be
provided to the DAC members before the meeting. Any member of the
public may submit a written statement to the committee at any time.

    Issued in Washington, DC.
Erik W. Amend,
Manager, Executive Office, UAS Integration Office, AUS-10, Federal
Aviation Administration.
[FR Doc. 2020-09394 Filed 5-1-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Notices]
[Pages 45335-45339]
[FR Doc No: 2022-16170]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1601]

Outsourcing Facility Fee Rates for Fiscal Year 2023

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2023 rates for the establishment and reinspection fees
related to entities that compound human drugs and elect to register as
outsourcing facilities under the Federal Food, Drug, and Cosmetic Act
(FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual
establishment fee from outsourcing facilities, as well as a
reinspection fee for each reinspection of an outsourcing facility. This
document establishes the FY 2023 rates for the small business
establishment fee ($5,941), the non-small business establishment fee
($18,661), and the reinspection fee ($17,823) for outsourcing
facilities; provides information on how the fees for FY 2023 were
determined; and describes the payment procedures outsourcing facilities
should follow.

DATES: These fee rates are effective October 1, 2022, and will remain
in effect through September 30, 2023.

ADDRESSES: Office of Financial Management, Food and Drug
Administration, 4041 Powder Mill Rd., Rm. 61075, Beltsville, MD.

FOR FURTHER INFORMATION CONTACT: For more information on human drug
compounding and outsourcing facility fees, visit FDA's website at:
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.
    For questions relating to this notice, contact: Robert Marcarelli,
User Fees Support Team at DUF-Budget, Food and Drug Administration, [email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 503B of the FD&C Act (21 U.S.C. 353b), a human drug

compounder can become an ``outsourcing facility.'' Outsourcing
facilities, as defined in section 503B(d)(4), are facilities that meet
all the conditions described in section 503B(a), including registering
with FDA as an outsourcing facility and paying an annual establishment
fee. If the conditions of section 503B are met, a drug compounded by or
under the direct supervision of a licensed pharmacist in an outsourcing
facility is exempt from three sections of the FD&C Act: (1) section
502(f)(1) (21 U.S.C. 352(f)(1)) concerning the labeling of drugs with
adequate directions for use; (2) section 505 (21 U.S.C. 355) concerning
the approval of human drug products under new drug applications (NDAs)
or abbreviated new drug applications (ANDAs); and (3) section 582 (21
U.S.C. 360eee-1) concerning drug supply chain security requirements.
Drugs compounded in outsourcing facilities are not exempt from the
requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) concerning current good manufacturing practice
requirements for drugs.
    Section 744K of the FD&C Act (21 U.S.C. 379j-62) authorizes FDA to
assess and collect the following fees associated with outsourcing
facilities: (1) an annual establishment fee from each outsourcing
facility and (2) a reinspection fee from each outsourcing facility
subject to a reinspection (see section 744K(a)(1) of the FD&C Act).
Under statutorily defined conditions, a qualified applicant may pay a
reduced small business establishment fee (see section 744K(c)(4) of the
FD&C Act).
    FDA announced in the Federal Register of November 24, 2014 (79 FR
69856), the availability of a final guidance for industry entitled
``Fees for Human Drug Compounding Outsourcing Facilities Under Sections
503B and 744K of the FD&C Act.'' The guidance provides additional
information on the annual fees for outsourcing facilities and
adjustments required by law, reinspection fees, how to submit payment,
the effect of failure to pay fees, and how to qualify as a small
business to obtain a reduction of the annual establishment fee. This
guidance can be accessed on FDA's website at: https://www.fda.gov/media/136683/download.

II. Fees for FY 2023

A. Methodology for Calculating FY 2023 Adjustment Factors

1. Inflation Adjustment Factor
    Section 744K(c)(2) of the FD&C Act specifies the annual inflation
adjustment for outsourcing facility fees. The inflation adjustment has
two components: one based on FDA's payroll costs and one based on FDA's
non-payroll costs for the first 3 of the 4 previous fiscal years. The
payroll component of the annual inflation adjustment is calculated by
taking the average change in FDA's per-full time equivalent (FTE)
personnel compensation and benefits (PC&B) in the first 3 of the 4
previous fiscal years (see section 744K(c)(2)(A)(ii) of the FD&C Act).
FDA's total annual spending on PC&B is divided by the total number of
FTEs per fiscal year to determine the average PC&B per FTE.
    Table 1 summarizes the actual cost and FTE data for the specified
fiscal years and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2023. The 3-year average is 1.3918 percent.

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                                                                                3-Year
                                                 FY 2019           FY 2020           FY 2021          average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,620,052,000    $2,875,592,000    $3,039,513,000  ..............
Total FTE.................................           $17,144           $17,535           $18,501  ..............
PC&B per FTE..............................          $152,826          $163,992          $164,289  ..............
Percent Change From Prevous Year..........          -3.3120%           7.3063%           0.1811%         1.3918%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this
1.3918 percent should be multiplied by the proportion of PC&B to total
costs of an average FDA FTE for the same 3 fiscal years.

                      Table 2--FDA PC&Bs as a Percent of FDA Total Costs of an Average FTE
----------------------------------------------------------------------------------------------------------------
                                                                                3-Year
                                                 FY 2019           FY 2020           FY 2021          average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,620,052,000    $2,875,592,000    $3,039,513,000  ..............
Total Costs...............................    $5,663,389,000    $6,039,320,747    $6,105,480,000  ..............
PC&B Percent..............................          46.2630%          47.6145%          49.7834%        47.8870%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.3918 percent multiplied by 47.8870
percent, or 0.6665 percent.
    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the
portion of the inflation adjustment for non-payroll costs for FY 2023
is equal to the average annual percent change in the Consumer Price
Index (CPI) for urban consumers (U.S. City Average; Not Seasonally
Adjusted; All items; Annual Index) for the first 3 years of the
preceding 4 years of available data, multiplied by the proportion of
all non-PC&B costs to total costs of an average FDA FTE for the same
period.
    Table 2 provides the summary data for the percent change in the
specified CPI for U.S. cities. These data are published by the Bureau
of Labor Statistics and can be found on its website: https://data.bls.gov/cgi-bin/surveymost?cu. The data can be viewed by checking
the box marked ``U.S. city average, All items--CUUR0000SA0'' and then
selecting ``Retrieve Data.''

                   Table 3--Annual and 3-Year Average Percent Change in U.S. City Average CPI
----------------------------------------------------------------------------------------------------------------
                                                                                3-Year
                                                       2019            2020            2021           average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................          255.66          258.81          270.97  ..............
Annual Percent Change...........................         1.8120%         1.2337%         4.6980%         2.5812%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this
2.5812 percent should be multiplied by the proportion of all non-PC&B
costs to total costs of an average FTE for the same 3 fiscal years. The
proportion of all non-PC&B costs to total costs of an average FDA FTE
for FYs 2019 to 2021 is 52.1130 percent (100 percent minus 47.8870
percent equals 52.1130 percent). Therefore, the non-pay adjustment is
2.5812 percent times 52.1130 percent, or 1.3451 percent.
    The PC&B component (0.6665 percent) is added to the non-PC&B
component (1.3451 percent), for a total inflation adjustment of 2.0116
percent (rounded). Section 744K(c)(2)(A)(i) of the FD&C Act specifies
that one is added to that figure, making the inflation adjustment
1.020116.
    Section 744K(c)(2)(B) of the FD&C Act provides for this inflation
adjustment to be compounded after FY 2015. This factor for FY 2023
(2.0116 percent) is compounded by adding one to it, and then
multiplying it by one plus the inflation adjustment factor for FY 2022
(16.4796 percent), as published in the Federal Register on July 28,
2021 (86 FR 40588). The result of this multiplication of the inflation
factors for the 8 years since FY 2015 (1.020116 x 1.164796) becomes the
inflation adjustment for FY 2023. For FY 2023, the inflation adjustment
is 18.8227 percent (rounded). We then add one, making the FY 2023
inflation adjustment factor 1.188227.
2. Small Business Adjustment Factor
    Section 744K(c)(3) of the FD&C Act specifies that in addition to
the inflation adjustment factor, the establishment fee for non-small
businesses is to be further adjusted for a small business adjustment
factor. Section 744K(c)(3)(B) of the FD&C Act provides that the small
business adjustment factor is the adjustment to the establishment fee
for non-small businesses that is necessary to achieve total fees
equaling the amount that FDA would have collected if no entity
qualified for the small business exception in section 744K(c)(4) of the
FD&C Act. Additionally, section 744K(c)(5)(A) states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the crediting of fees from the previous year to
the next year if FDA overestimated the amount of the small business
adjustment factor for such previous fiscal year.
    Therefore, to calculate the small business adjustment to the
establishment fee for non-small businesses for FY 2023, FDA must
estimate: (1) the number of outsourcing facilities that will pay the
reduced fee for small businesses for FY 2023 and (2) the total fee
revenue it would have collected if no entity had qualified for the
small business exception (i.e., if each entity that registers as an
outsourcing facility for FY 2023 were to pay the inflation-adjusted fee
amount of $17,823).
    With respect to (1), FDA estimates that 10 entities will qualify
for small business exceptions and will pay the reduced fee for FY 2023.
With respect to (2), to estimate the total number of entities that will
register as outsourcing facilities for FY 2023, FDA used data submitted
by outsourcing facilities through the voluntary registration process,
which began in December 2013. Accordingly, FDA estimates that 78
outsourcing facilities, including 10 small businesses, will be
registered with FDA in FY 2023.
    If the projected 78 outsourcing facilities paid the full inflation-
adjusted fee of $17,823, this would result in total revenue of
$1,390,194 in FY 2023 ($17,823 x 78). However, 10 of the entities that
are expected to register as outsourcing facilities for FY 2023 are
projected to qualify for the small business exception and to pay one-
third of the full fee ($5,941 x 10), totaling $59,410 instead of paying
the full fee ($17,823 x 10), which would total $178,230. This would
leave a potential shortfall of $118,820 ($178,230 minus $59,410).
    Additionally, section 744K(c)(5)(A) of the FD&C Act states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the crediting of fees from the previous year to
the next year if FDA overestimated the amount of the small business
adjustment factor for such previous fiscal year. FDA has determined
that it is appropriate to credit excess fees collected from the last
completed fiscal year, due to the inability to conclusively determine
the amount of excess fees from the fiscal year that is in progress at
the time this calculation is made. This crediting is done by comparing
the small business adjustment factor for the last completed fiscal
year, FY 2021 ($2,441), to what would have been the small business
adjustment factor for FY 2021 ($1,582) if FDA had estimated perfectly.
    The calculation for what the small business adjustment would have
been if FDA had estimated perfectly begins by determining the total
target collections (15,000 x (inflation adjustment factor) x (number of
registrants). For the most recent complete fiscal year, FY 2021, this
was $1,400,970 ($17,085 x 82). The actual FY 2021 revenue from the 82
total registrants (i.e., 72 registrants paying FY 2021 non-small
business establishment fee and 10 small business registrants) paying
establishment fees is $1,287,070. $1,287,070 is calculated as follows:
(FY 2021 Non-Small Business Establishment Fee adjusted for inflation
only) x (total number of registrants in FY 2021 paying Non-Small
Business Establishment Fee) + (FY 2021 Small Business Establishment
Fee) x (total number of small business registrants in FY 2021 paying
Small Business Establishment Fee). $17,085 x 72 + $5,695 x 10 =
$1,287,070. This left a shortfall of $113,900 from the estimated total
target collection amount ($1,400,970 minus $1,287,070). This amount
($113,900) divided by the total number of registrants in FY 2021 paying
Standard Establishment Fee (72) equals $1,582.
    The difference between the small business adjustment factor used in
FY 2021 and the small business adjustment factor that would have been
used had FDA estimated perfectly is $859 ($2,441 minus $1,582). The
$859 (rounded to the nearest dollar) is then multiplied by the number
of actual registrants who paid the standard fee for FY 2021 (72), which
provides us a total excess collection of $61,831 in FY 2021.
    Therefore, to calculate the small business adjustment factor for FY
2023, FDA subtracts $61,831from the projected shortfall of $118,820 for
FY 2023 to arrive at the numerator for the small business adjustment
amount, which equals $56,989. This number divided by 68 (the number of
expected non-small businesses for FY 2023) is the

small business adjustment amount for FY 2023, which is $838 (rounded to
the nearest dollar).

B. FY 2023 Rates for Small Business Establishment Fee, Non-Small
Business Establishment Fee, and Reinspection Fee

1. Establishment Fee for Qualified Small Businesses \1\
---------------------------------------------------------------------------

    \1\ To qualify for a small business reduction of the FY 2023
establishment fee, entities had to submit their exception requests
by April 30, 2022. See section 744K(c)(4)(B) of the FD&C Act. The
time for requesting a small business exception for FY 2023 has now
passed. An entity that wishes to request a small business exception
for FY 2024 should consult section 744K(c)(4) of the FD&C Act and
section III.D of FDA's guidance for industry entitled ``Fees for
Human Drug Compounding Outsourcing Facilities Under sections 503B
and 744K of the FD&C Act,'' which can be accessed on FDA's website
at https://www.fda.gov/media/136683/download.
---------------------------------------------------------------------------

    The amount of the establishment fee for a qualified small business
is equal to $15,000 multiplied by the inflation adjustment factor for
that fiscal year, divided by 3 (see section 744K(c)(4)(A) and (c)(1)(A)
of the FD&C Act). The inflation adjustment factor for FY 2023 is
1.188227. See section II.A.1 of this document for the methodology used
to calculate the FY 2023 inflation adjustment factor. Therefore, the
establishment fee for a qualified small business for FY 2023 is one
third of $17,823, which equals $5,941 (rounded to the nearest dollar).
2. Establishment Fee for Non-Small Businesses
    Under section 744K(c) of the FD&C Act, the amount of the
establishment fee for a non-small business is equal to $15,000
multiplied by the inflation adjustment factor for that fiscal year,
plus the small business adjustment factor for that fiscal year, and
plus or minus an adjustment factor to account for over or under
collections due to the small business adjustment factor in the prior
year. The inflation adjustment factor for FY 2023 is 1.188227. The
small business adjustment amount for FY 2023 is $838. See section
II.A.2 of this document for the methodology used to calculate the small
business adjustment factor for FY 2023. Therefore, the establishment
fee for a non-small business for FY 2023 is $15,000 multiplied by
1.188227plus $838, which equals $18,661 (rounded to the nearest
dollar).
3. Reinspection Fee
    Section 744K(c)(1)(B) of the FD&C Act provides that the amount of
the FY 2023 reinspection fee is equal to $15,000, multiplied by the
inflation adjustment factor for that fiscal year. The inflation
adjustment factor for FY 2023 is 1.188227. Therefore, the reinspection
fee for FY 2023 is $15,000 multiplied by 1.188227, which equals $17,823
(rounded to the nearest dollar). There is no reduction in this fee for
small businesses.

C. Summary of FY 2023 Fee Rates

                   Table 4--Outsourcing Facility Fees
------------------------------------------------------------------------

------------------------------------------------------------------------
Qualified Small Business Establishment Fee..............       $5,941.00
Non-Small Business Establishment Fee....................       18,661.00
Reinspection Fee........................................       17,823.00
------------------------------------------------------------------------

III. Fee Payment Options and Procedures

A. Establishment Fee

    Once an entity submits registration information and FDA has
determined that the information is complete, the entity will incur the
annual establishment fee. FDA will send an invoice to the entity, via
email to the email address indicated in the registration file. The
invoice will contain information regarding the obligation incurred, the
amount owed, and payment procedures. A facility will not be registered
as an outsourcing facility until it has paid the annual establishment
fee under section 744K of the FD&C Act. Accordingly, it is important
that facilities seeking to operate as outsourcing facilities pay all
fees immediately upon receiving an invoice. If an entity does not pay
the full invoiced amount within 15 calendar days after FDA issues the
invoice, FDA will consider the submission of registration information
to have been withdrawn and adjust the invoice to reflect that no fee is
due.
    Outsourcing facilities that registered in FY 2022 and wish to
maintain their status as an outsourcing facility in FY 2023 must
register during the annual registration period that lasts from October
1, 2022, to December 31, 2022. Failure to register and complete payment
by December 31, 2022, will result in a loss of status as an outsourcing
facility on January 1, 2023. Entities should submit their registration
information no later than December 10, 2022, to allow enough time for
review of the registration information, invoicing, and payment of fees
before the end of the registration period.

B. Reinspection Fee

    FDA will issue invoices for each reinspection after the conclusion
of the reinspection, via email to the email address indicated in the
registration file or via regular mail if email is not an option.
Invoices must be paid within 30 days.

C. Fee Payment Procedures

    1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). Secure electronic
payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. (Note: only full payments are accepted. No
partial payments can be made online.) Once you search for your invoice,
click ``Pay Now'' to be redirected to Pay.gov. Electronic payment
options are based on the balance due. Payment by credit card is
available for balances less than $25,000. If the balance exceeds this
amount, only the ACH option is available. Payments must be made using
U.S. bank accounts as well as U.S. credit cards.
    2. If paying with a paper check: Checks must be in U.S. currency
from a U.S. bank and made payable to the Food and Drug Administration.
Payments can be mailed to: Food and Drug Administration, P.O. Box
979033, St. Louis, MO 63197-9000. Include invoice number on check. If a
check is sent by a courier that requests a street address, the courier
can deliver the check to: U.S. Bank, Attn: Government Lockbox 979033,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only. If you have any questions
concerning courier delivery, contact the U.S. Bank at<PHONE_NUMBER>).
    3. When paying by wire transfer, the invoice number must be
included. Without the invoice number the payment may not be applied.
Regarding reinspection fees, if the payment amount is not applied, the
invoice amount will be referred to collections. The originating
financial institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required that the
outsourcing facility add that amount to the payment to ensure that the
invoice is paid in full. Use the following account information when
sending a wire transfer: U.S. Dept of the Treasury, TREAS NYC, 33
Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No.
021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number
is 53-0196965.

    Dated: July 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16170 Filed 7-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Pages 30175-30176]
[FR Doc No: 2011-12623]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792)

Draft Guidance for Clinical Investigators, Industry, and FDA
Staff: Financial Disclosure by Clinical Investigators; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Clinical
Investigators, Industry, and FDA Staff: Financial Disclosure by
Clinical Investigators.'' This draft guidance is intended to assist
clinical investigators, industry, and FDA staff in interpreting and
complying with the regulations governing financial disclosure by
clinical investigators. This guidance provides FDA's responses to the
most frequently asked questions regarding financial disclosure by
clinical investigators.

DATES: Although comments on any guidance can be submitted at any time
(see 21 CFR 10.115(g)(5)), to ensure that the Agency considers a
comment on this draft guidance before it begins work on the final
version of the guidance, electronic or written comments on the draft
guidance should be submitted by July 25, 2011. Submit written comments
on the draft guidance to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.regulations.gov. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002 (1-
888-463-6332 or<PHONE_NUMBER>); or the Office of Communication, Outreach
and Development (HFM-40), Center for Biologics Evaluation and Research,
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448 (1-800-835-4709 or<PHONE_NUMBER>); or the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4622, Silver Spring, MD 20993 (1-800-
638-2041 or<PHONE_NUMBER>). Send one self-addressed adhesive label to
assist the office in processing your requests.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Marsha Melvin, Office of Good
Clinical Practice, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5170, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Guidance for Clinical Investigators, Industry, and FDA Staff:
Financial Disclosure by Clinical Investigators.'' This guidance is
intended to assist clinical investigators, industry, and FDA staff in
interpreting and complying with the regulations governing financial
disclosure by clinical investigators, part 54 (21 CFR part 54), and to
provide FDA's responses to the most frequently asked questions
regarding financial disclosure by clinical investigators. When
finalized, this guidance will supersede ``Guidance for Industry--
Financial Disclosure by Clinical Investigators'' (March 20, 2001,
Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, and Center for Devices and Radiological
Health).
    This guidance also responds to recommendations made by the Office
of the Inspector General (OIG), Department of Health and Human
Services, in their report entitled ``The Food and Drug Administration's
Oversight of Clinical Investigators' Financial Information.'' \1\ The
OIG's recommendations were intended to strengthen FDA's oversight

and review of clinical investigators' financial disclosures.
Specifically, the draft guidance will describe: (1) The sponsor's
responsibility to collect the financial disclosure information prior to
an investigator participating in a study and ensure that all required
forms and attachments are submitted in marketing applications; (2) what
is meant by ``due diligence'' in obtaining financial disclosures from
investigators; and (3) how FDA will review financial disclosure
information. The guidance will also seek comment on the circumstances
under which FDA should consider public release of financial disclosure
information related to an approved marketing application.
---------------------------------------------------------------------------

    \1\ OIG report OEI-05-07-00730 available at http://oig.hhs.gov/oei/reports/oei-05-07-00730.pdf. (FDA has verified the Web site
address, but FDA is not responsible for any subsequent changes to
the Web site after this document publishes in the Federal Register.)
---------------------------------------------------------------------------

    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 Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 54 and 21 CFR parts 312 and 812 have
been approved under OMB control number 0910-0396; OMB control number
0910-0014; and OMB control number 0910-0078.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this draft
guidance document. It is no longer necessary to send two copies of
mailed comments. Identify comments with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm.

    Dated: May 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12623 Filed 5-23-11; 8:45 am]
BILLING CODE 4160-01-P


DCN 5 1045 North Atlantic Case Study Docket Program List SAS Programs DCN # Filename Program Use Description Data used and created 5 1045 North Atlantic Case Study Docket Program List. pdf N/ A Informational Description of data and program types Uses: None Creates: None 5 1046 North Atlantic New Distances. sas North Atlantic New Distances Distance Measure Replace previous distance measures for Long Island New York residents Uses: new_ distances. sas7bdat, li_ distances. sas7bdat Creates: distances2. sas7bdat 5 1047 North Atlantic Catch Rates  Hicks Method. sas North Atlantic Catch Rates  Hick Method Catch Rate Calculation Calculates average catch rates in fish per trip for North Atlantic sites Uses: MRFSS intercept data from 1990 to 1994 ( see DCN X XXXX)

Creates: na_ hicks_ by_ wave. sas7bdat 5 1048 North Atlantic Welfare  New Hicks Rates. sas North Atlantic Welfare  New Hicks Rates Per Trip Welfare Estimation Estimates the per trip welfare gain from catching an additional fish per trip and from percentage increases in catch per trip based on I& E reductions Uses: na6. sas7bdat, distances2. sas7bdat, nmfs_ per_ hicks. sas7bdat, na_ hicks_ by_ wave. sas7bdat Creates: Printed Output ( see DCN XXXXX

5 1049 Calculate Discount Factors from Stratus Excel File v2. sas Calculate Discount Factors from Stratus Excel File Discount Factors Calculate weighted discount factors for 3% and 7% based on species group composition. Uses: rec. losses. feb14. plus. reduced. loss. xls Creates: Printed Output ( see DCN XXXXX DCN 5 1045 North Atlantic Case Study Docket Program List MRFSS Survey Data DCN # Filename Program Use Description Data used and created 5 1057 Unpack MRFSS Intercept Data for 90_ 91_ 92. sas Unpack MRFSS Intercept Data Extract Survey Data Exports MRFSS Intercept Survey data sets. Uses: int90ag. xpt, int91ag. xpt, int92ag. xpt, int93ag. xpt, int94ag. xpt Creates: Individual wave files The data sets containing the MRFSS intercept survey data are available for download from the world wide web. These data can found at http:// www. st. nmfs. gov/ recreational/ index. html, and include int90ag. zip, int91ag. zip, int92ag. xpt, int93ag. xpt, and int94ag. xpt. Zipped versions of the data sets have been included under DCN X XXXX.

Excel Files DCN # Filename Program Use Description Data used and created 5 1053 Rec_ losses_ 2_ 17_ 03_ b aseline. xls Recreation Losses in Baseline Catch Rates Percentage changes in catch rates by species group for the baseline scenario Uses: MRFSS landings data, output from DCN X XXXX Creates: Nothing 5 1054 Rec_ losses_ 2_ 17_ 03_ r educed. xls Recreation Losses Preferred Technology Option Catch Rates Percentage changes in catch rates by species group for the preferred technology option Uses: MRFSS landings data, output from DCN X XXXX ( discount factors)

Creates: Nothing 5 1052 Calculate Welfare for North Atlantic 2_ 17_ 03. xls Welfare Calculation Welfare Calculates total recreational welfare by species group and applies discount factors Uses: output from DCN X XXXX ( per trip welfare), output from DCN X XXXX ( discount factors)

Creates: Nothing


[Federal Register: June 29, 2010 (Volume 75, Number 124)]
[Notices]
[Page 37450-37451]
[DOCID:fr29jn10-77]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0094]

Draft Guidance: The Judicious Use of Medically Important
Antimicrobial Drugs in Food-Producing Animals; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance (209) entitled ``The
Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals.'' This draft guidance is intended to inform the
public of FDA's current thinking on the use of medically important
antimicrobial drugs in food-producing animals.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 30, 2010.

ADDRESSES:  Submit written requests for single copies of the guidance
to the Communications Staff (HFV-12), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. Additional copies of this guidance are
available from the Office of Communication, Outreach and Development
(OCOD) (HFM-40), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or
301-827-1800, or e-mail<EMAIL_ADDRESS>See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
    Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for
Veterinary Medicine (HFV-1), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance
(209) entitled ``The Judicious Use of Medically Important
Antimicrobial Drugs in Food-Producing Animals.'' Antimicrobial drugs
have been widely used in human and veterinary medicine for more than 50
years, with tremendous benefits to both human and animal health. The
development of resistance to this important class of drugs, and the
resulting loss of their effectiveness as antimicrobial therapies, poses
a serious public health threat. Misuse and overuse of antimicrobial
drugs creates selective evolutionary pressure that enables
antimicrobial resistant bacteria to increase in numbers more rapidly
than antimicrobial susceptible bacteria and thus increases the
opportunity for individuals to become infected by resistant bacteria.
Because antimicrobial drug use contributes to the emergence of drug
resistant organisms, these important drugs must be used judiciously in
both animal and human medicine to slow the development of resistance.
Using these drugs judiciously means that unnecessary or inappropriate
use should be avoided. Although efforts to assure judicious use should
be directed at all uses of antimicrobial drugs, the focus of this
document is on the use of medically important antimicrobial drugs in
food-producing animals.
    In regard to the use of antimicrobial drugs in animals, concerns
have been raised by the public and components of the scientific and
public health communities that a significant contributing factor to
antimicrobial resistance is the use of medically important
antimicrobial drugs in food-producing animals for production or growth-
enhancing purposes. This document summarizes some of the key scientific
reports on the use of antimicrobial drugs in animal agriculture and
outlines FDA's current thinking on strategies for assuring that
medically important antimicrobial drugs are used judiciously in food-
producing animals in order to help minimize antimicrobial resistance
development.
    Based on a consideration of the available scientific information,
FDA is making a number of recommendations regarding the appropriate or
judicious use of medically important antimicrobial drugs in food-
producing animals. These recommendations include phasing in such
measures as follows: (1) Limiting medically important antimicrobial
drugs to uses in food-producing animals that are considered necessary
for assuring

animal health and (2) limiting such drugs to uses in food-producing
animals that include veterinary oversight or consultation. Developing
strategies for reducing antimicrobial resistance is critically
important for protecting both public and animal health. Collaboration
involving both the public and animal health communities on the
development and implementation of such strategies is needed to assure
that the public health is protected while also assuring that the health
needs of animals are addressed.
    This draft guidance discusses FDA's general public health concerns
regarding the potential impact of certain uses of medically important
antimicrobial drugs in food-producing animals on the development of
antimicrobial resistance, and provides two broad recommendations
regarding such use. The agency intends to issue further guidance in the
near future to provide more specific information on approaches for
implementing the recommendations outlined in this draft guidance.

II. Significance of Guidance

    This level 1 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 agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

    FDA concludes that there are no collections of information under
the Paperwork Reduction Act of 1995.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/default.htm or http://
www.regulations.gov.

    Dated: June 10, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15289 Filed 6-28-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: April 27, 2010 (Volume 75, Number 80)]
[Notices]
[Page 22122-22123]
[DOCID:fr27ap10-43]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No.: 12478-003]

Gibson Dam Hydroelectric Company, LLC; Notice of Application
Accepted for Filing and Soliciting Motions To Intervene and Protests

April 20, 2010.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Major Project--Existing Dam.
    b. Project No.: P-12478-003.
    c. Date filed: August 28, 2009.
    d. Applicant: Gibson Dam Hydroelectric Company, LLC.
    e. Name of Project: Gibson Dam Hydroelectric Project.
    f. Location: On the Sun River, near the towns of Augusta and
Fairfield, Lewis and Clark and Teton Counties, Montana. The project
would occupy 95.34 acres of federal land administered by the U.S.
Forest Service and 19.39 acres of federal land administered by the U.S.
Bureau of

Land Management for a total of 114.73 acres of federal land.
    g. Filed Pursuant to: Federal Power Act, 16 USC 791 (a)-825(r).
    h. Applicant Contact: Steve C. Marmon, Thom A. Fischer, Whitewater
Engineering Corporation, 3633 Alderwood Ave., Bellingham, WA 98225,
(360) 738-9999.
    i. FERC Contact: Matt Cutlip, phone:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and eight copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice and Procedures require all
intervenors filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. This application has been accepted for filing, but is not ready
for environmental analysis at this time.
    l. The proposed project would utilize the existing facilities of
the U.S. Bureau of Reclamation's Gibson Dam including the reservoir,
existing valve house, and two existing dam outlet pipes; and would
consist of the following new facilities: (1) Two new 72-inch-diameter
penstocks extending 40 feet from the existing outlet pipes to the
powerhouse; (2) a new powerhouse located near the toe of the dam with
four turbine/generating units with total installed capacity of 15
megawatts; (3) a new 25.8-mile, 34.5/69 kV overhead and underground
transmission line from the powerhouse to an interconnection point with
Sun River Electric Cooperative, Inc.'s existing 69 kV transmission line
at Jackson's Corner; (4) a new 34.5/69 kV step-up substation; (5) a new
maintenance building located approximately 1,400 feet downstream of the
powerhouse adjacent to existing Gibson Dam operations facilities; and
(6) appurtenant facilities. The average annual generation is estimated
to be 40 gigawatt-hours.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at  http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) named in this
public notice.
    Anyone may submit a protest or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210, 385.211, and 385.214. In determining the appropriate action to
take, the Commission will consider all protests filed, but only those
who file a motion to intervene in accordance with the Commission's
Rules may become a party to the proceeding. Any protests or motions to
intervene must be received on or before the specified deadline date for
the particular application.
    When the application is ready for environmental analysis, the
Commission will issue a public notice requesting comments,
recommendations, terms and conditions, or prescriptions.
    All filings must (1) bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE,'' ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION,'' or ``COMPETING APPLICATION;'' (2) set forth in
the heading the name of the applicant and the project number of the
application to which the filing responds; (3) furnish the name,
address, and telephone number of the person protesting or intervening;
and (4) otherwise comply with the requirements of 18 CFR 385.2001
through 385.2005.
    Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-9686 Filed 4-26-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 5 (Monday, January 9, 2012)]
[Rules and Regulations]
[Pages 1017-1019]
[FR Doc No: 2012-135]

=======================================================================
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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 740, 742 and 774

[Docket No. 110825537-1539-02]
RIN 0694-AF38

Export and Reexport License Requirements for Certain Microwave
and Millimeter Wave Electronic Components

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: This rule imposes a license requirement on exports and
reexports to all destinations other than Canada of two types of
microwave and millimeter wave electronic components. The two components
are packaged high electron mobility transistors and packaged microwave
``monolithic integrated circuits'' power amplifiers that meet certain
criteria with respect to frequency range, size and output power. BIS
takes this step to control exports and reexports of these components,
which have uses in military radar systems as well as in civilian radar
and telecommunications systems. The U.S. Government also plans to
propose adding these components to the Dual List of the Wassenaar
Arrangement on Export Controls for Conventional Arms and Dual-Use Goods
and Technologies (Wassenaar Arrangement Dual Use List) in 2012.

DATES: Effective date: January 9, 2012.

FOR FURTHER INFORMATION CONTACT: Brian Baker, Director, Electronics and
Materials Division, Office of National Security and Technology Transfer
Controls,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This rule imposes a license requirement on
exports and reexports to all destinations other than Canada of two
types of microwave and millimeter wave electronic components. The two
components are packaged high electron mobility transistors (HEMT) and
packaged microwave ``monolithic integrated circuits'' (MMIC) power
amplifiers. The U.S. Government plans to propose adding these
components to the Wassenaar Arrangement Dual-Use List in 2012.
    This rule imposes this license requirement by creating a new Export
Control Classification Number (ECCN) 3A982 containing two ``items''
paragraphs. Paragraph 3A982.a covers packaged HEMTs with physical
dimensions less than 43 mm per side, rated for operation at frequencies
from 2.7 GHz up to and including 3.2 GHz and having either an average
output power equal to or greater than 48 W (46.8 dBm); or a pulsed
output power equal to or greater than 240 W (53.8 dBm) and a duty cycle
of 20 percent or more.
    Paragraph 3A982.b covers packaged MMIC power amplifiers with
physical dimensions less than 43mm per side, rated for operation at
frequencies from 2.7 GHz up to and including 3.2 GHz and having either
an average output power equal to or greater than 15W (41.7 dBm); or a
pulsed output power equal to or greater than 75 W (48.75 dBm) and a
duty cycle of 20 percent or more.
    This rule also creates new ECCNs 3D982 and 3E982 to control the
software and technology, respectively, associated with the new controls
set forth in new ECCN 3A982.
    This rule also revises License Exception STA (Sec.  740.20 of the
EAR) to preclude use of License Exception STA for any export, reexport
or transfer of items in ECCN 3A982.b.
    The U.S. Government plans to submit a proposal for control of the
commodities covered by ECCN 3A982 in 2012. BIS publishes this rule to
protect against the diversion of these items to users or for uses that
would threaten the security of the United States or that of its allies.
    The application of regional stability and antiterrorism controls to
the items covered by this rule imposes a foreign policy control.
Section 6(f) of the Export Administration Act requires that a report be
delivered to Congress before imposing such controls. The report was
delivered to Congress on December 29, 2011.
    The Export Administration Act of 1979, as amended, expired on
August 21, 2001. Since this lapse, the President has continued the EAR
in effect through Executive Order 13222 of August 17, 2001 (3 CFR, 2001
Comp. 783 (2002)), under the authority of the International Emergency
Economic Powers Act, with the most recent extension being implemented
by the Notice of August 12, 2011 (76 FR 50661 (August 16, 2011)). BIS
continues to carry out the provisions of the Act, as appropriate and to
the extent permitted by law, pursuant to Executive Order 13222.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distribute impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated a ``significant regulatory
action,'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget (OMB).
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor is subject to a penalty for failure to
comply with, a collection of information, subject to the

requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) (PRA), unless that collection of information displays a currently
valid OMB Control Number. This rule affects an existing approved
collection 0694-0088, Simple Network Application Process and
Multipurpose Application Form for which the estimated burden is 58
minutes per submission. BIS does not believe that this rule will
materially increase the number of submissions under this collection.
    3. This rule does not contain policies with Federalism implications
as that term is defined under E.O. 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public comment and a delay in effective date are inapplicable because
this regulation involves a military or foreign affairs function of the
United States (See 5 U.S.C. 553(a)(1)). BIS is implementing this rule
to protect U.S. national security or foreign policy interests by
imposing an export and reexport license requirement on two items that
are used in military radar systems. The U.S. Government plans to
propose that these two items be added to the Wassenaar Arrangement
Dual-Use List. Immediate imposition of a license requirement is
necessary to effect the national security and foreign policy goals of
this rule. Immediate implementation will allow BIS to prevent exports
of these items to users and for uses that pose a security threat to the
United States or its allies. If BIS published a proposed rule
soliciting notice and comment, the resulting delay in implementation
would afford an opportunity to export these items to users and uses
that pose such a security threat, thereby undermining the purpose of
the rule. Furthermore, by demonstrating its own willingness to impose a
license requirement on its exports of these items, this rule will
provide support for the planned United States proposal that the
Wassenaar Arrangement should add these items to its Dual-Use List.
Inclusion of these items on the Wassenaar Arrangement Dual-Use and the
resulting implementation of export license requirements by other
Wassenaar Arrangement will further the goal of this rule by removing
potential sources of these items for parties who would act in ways that
threaten the security of the United States or its allies.
    Further, no other law requires that a notice of proposed rulemaking
and an opportunity for public comment be given for this rule. Because a
notice of proposed rulemaking and an opportunity for public comment are
not required to be given for this rule by 5 U.S.C. 553, or by any other
law, the analytical requirements of the Regulatory Flexibility Act, 5
U.S.C. 601 et seq., are not applicable.

List of Subjects

15 CFR Part 740

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    Accordingly, the Export Administration Regulations (15 CFR parts
730-774) are amended as follows:

PART 740--[AMENDED]

0
1. The authority citation for part 740 continues to read as follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp.,
p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice
of August 12, 2011, 76 FR 50661 (August 16, 2011).

0
2. Section 740.20 is amended by adding paragraph (b)(2)(viii) to read
as follows:

Sec.  740.20  License Exception Strategic Trade Authorization (STA).

* * * * *
    (b) * * *
    (2) * * *
    (viii) License Exception STA may not be used to export, reexport or
transfer any packaged microwave ``monolithic integrated circuits''
(MMIC) power amplifiers classified under ECCN 3A982.b.
* * * * *

PART 742--[AMENDED]

0
3. The authority citation for part 742 continues to read as follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058,
43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3
CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp.,
p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential
Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003;
Notice of August 12, 2011, 76 FR 50661 (August 16, 2011); Notice of
November 9, 2011, 76 FR 70319 (November 10, 2011).

Sec.  742.6  [Amended]

0
4. Section 742.6(a)(1) is amended by adding the phrase ``3A982; 3D982;
3E982; '' immediately following the phrase ``for items described on the
CCL under ECCNs''

PART 774--[AMENDED]

0
5. The authority citation for part 774 continues to read as follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Notice of August 12, 2011, 76 FR 50661 (August 16, 2011).

0
6. Supplement No. 1 to Part 774--the Commerce Control List, Category 3,
Export Control Classification Number 3A001 is amended by adding two
sentences at the end of the ``Related Controls'' paragraph of the
``List of Items Controlled'' section to read as follows:

Supplement No. 1 to Part 774--The Commerce Control List

* * * * *
3A001 Electronic components and specially designed components
therefor, as follows (see List of Items Controlled).
* * * * *

List of Items Controlled

* * * * *
Related Controls: * * * (3) See ECCN 3A982.a for discrete microwave
transistors not controlled by paragraph .b.3 of this entry. (4)
Packaged microwave ``monolithic integrated circuits'' (packaged
MMIC) power amplifiers that operate within the frequency range
specified in 3A982.b and that have the dimensional and output power
characteristics specified for packaged MMIC power amplifiers
specified in ECCN 3A982 are controlled by ECCN 3A982 even if such
packaged MMIC power amplifiers also operate within the frequency
range specified in ECCN 3A001.b.2.a.
* * * * *

0
7. Supplement No. 1 to Part 774--the Commerce Control List, Category 3,
is amended by adding, immediately following the entry for Export
Control Classification Number (ECCN) 3A981 and immediately preceding
the entry for ECCN 3A991, a new ECCN 3A982 entry to read as follows:

3A982 Microwave or millimeter wave components that operate at
frequencies below those controlled by 3A001 as follows (See List of
Items Controlled).

License Requirements

Reasons for Control: RS, AT

------------------------------------------------------------------------
                Control(s)                          Country chart
------------------------------------------------------------------------
RS applies to entire entry................  RS Column 1
AT applies to entire entry................  AT Column 1
------------------------------------------------------------------------

License Exceptions

LVS: N/A
GBS: N/A
CIV: N/A

List of Items Controlled

Unit: $ value
Related Controls: (1) See ECCN 3A001.b.2 for certain microwave
``monolithic integrated circuits'' (MMIC) power amplifiers other
than those controlled by this entry. (2) See ECCN 3A001.b.3 for
discrete microwave transistors other than those controlled by this
entry. (3) See ECCN 3A001.h for high electron mobility transistors
that are solid state semiconductor switches, diodes or modules
rather than discrete microwave transistors.
Related Definitions: N/A
Items:
    a. Packaged high electron mobility transistors (HEMTs) with
physical dimensions less than 43 mm per side, rated for operation at
frequencies from 2.7 GHz up to and including 3.2 GHz and having any
of the following:
    a.1. An average output power equal to or greater than 48 W (46.8
dBm); or
    a.2. A pulsed output power equal to or greater than 240 W (53.8
dBm) and a duty cycle of 20 percent or more.
    b. Packaged microwave ``monolithic integrated circuits'' (MMIC)
power amplifiers with physical dimensions less than 43mm per side,
rated for operation at frequencies from 2.7 GHz up to and including
3.2 GHz and having either of the following:
    b.1. An average output power equal to or greater than 15W (41.7
dBm); or
    b.2. A pulsed output power equal to or greater than 75 W (48.75
dBm) and a duty cycle of 20 percent or more.

0
8. Supplement No. 1 to Part 774--The Commerce Control List is amended
by adding immediately following the entry for ECCN 3D980 and
immediately preceding the entry for ECCN 3D991 a new entry 3D982 to
read as follows:

3D982 ``Software'' ``specially designed'' for the ``development'' or
``production'' of microwave or millimeter wave components classified
under ECCN 3A982.

License Requirements

Reasons for Control: RS, AT

------------------------------------------------------------------------
                Control(s)                          Country chart
------------------------------------------------------------------------
RS applies to entire entry................  RS Column 1
AT applies to entire entry................  AT Column 1
------------------------------------------------------------------------

License Exceptions

CIV: N/A
TSR: N/A

List of Items Controlled

Unit: $ value
Related Controls: N/A
Related Definitions: N/A
Items: The list of items controlled is in the ECCN heading.

0
9. Supplement No. 1 to Part 774--The Commerce Control List is amended
by adding immediately following the entry for ECCN 3E980 and
immediately preceding the entry for ECCN 3E991 a new entry 3E982 to
read as follows:

3E982 ``Technology'' ``required'' for the ``development'' or
``production'' of microwave or millimeter wave components classified
under ECCN 3A982.

License Requirements

Reasons for Control: RS, AT

------------------------------------------------------------------------
                Control(s)                          Country chart
------------------------------------------------------------------------
RS applies to entire entry................  RS Column 1
AT applies to entire entry................  AT Column 1
------------------------------------------------------------------------

License Exceptions

CIV: N/A
TSR: N/A

List of Items Controlled

Unit: $ value
Related Controls: N/A
Related Definitions: N/A
Items: The list of items controlled is in the ECCN heading.

    Dated: January 3, 2012.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2012-135 Filed 1-6-12; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Pages 12459-12461]
[FR Doc No: 2022-04635]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]

Revocation of Two Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of COVID-19;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Bio-Rad Laboratories for the BioPlex 2200
SARS-CoV-2 IgG, and Quotient Suisse SA for the MosaiQ COVID-19 Antibody
Magazine. FDA revoked these Authorizations under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). The revocations, which include an
explanation of the reasons for each revocation, are reprinted in this
document.

DATES: The Authorizations are revoked as of January 11, 2022.

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

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. On July 1, 2021, FDA issued an
EUA to Bio-Rad Laboratories for the BioPlex 2200 SARS-CoV-2 IgG,
subject to the terms of the Authorization. Notice of the issuance of
this Authorization was published in the Federal Register on October 28,
2021 (86 FR 59738), as required by section 564(h)(1) of the FD&C Act.
On September 25, 2020, FDA issued an EUA to Quotient Suisse SA for the
MosaiQ COVID-19 Antibody Magazine, subject to the terms of the
Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on April 23, 2021 (86 FR 21749), as
required by section 564(h)(1) of the FD&C Act. Subsequent updates to
the Authorizations were made available on FDA's website. The
authorization of a device for emergency use under section 564 of the
FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked
when the criteria under section 564(c) of the FD&C Act for issuance of
such authorization are no longer met (section 564(g)(2)(B) of the FD&C
Act), or other circumstances make such revocation appropriate to
protect the public health or safety (section 564(g)(2)(C) of the FD&C
Act).

II. EUA Revocation Requests

    In a request received by FDA on December 20, 2021, Bio-Rad
Laboratories requested revocation of, and on January 11, 2022, FDA
revoked, the Authorization for the BioPlex 2200 SARS-CoV-2 IgG. Because
Bio-Rad Laboratories notified FDA that Bio-Rad Laboratories has not
commercialized the authorized product in the United States and
requested FDA revoke the BioPlex 2200 SARS-CoV-2 IgG, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization.
    In a request received by FDA on December 22, 2021, Quotient Suisse
SA requested termination of, and on January 11, 2022, FDA revoked, the
Authorization for the MosaiQ COVID-19 Antibody Magazine. Because
Quotient Suisse SA notified FDA that Quotient Suisse SA has decided not
to continue to commercially support the product and requested FDA
terminate the MosaiQ COVID-19 Antibody Magazine, FDA has determined
that it is appropriate to protect the public health or safety to revoke
this Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA of Bio-Rad Laboratories for the BioPlex 2200 SARS-
CoV-2 IgG and of Quotient Suisse SA for the MosaiQ COVID-19 Antibody
Magazine. The revocations in their entirety follow and provide an
explanation of the reasons for each revocation, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN04MR22.003

[GRAPHIC] [TIFF OMITTED] TN04MR22.004

    Dated: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04635 Filed 3-3-22; 8:45 am]
BILLING CODE 4164-01-C