[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Notices]
[Pages 44366-44369]
[FR Doc No: 2015-18283]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2015-0001]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final Notice.

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SUMMARY: New or modified Base (1-percent annual chance) Flood
Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or regulatory floodways
(hereinafter referred to as flood hazard determinations) as shown on
the indicated Letter of Map Revision (LOMR) for each of the communities
listed in the table below are finalized. Each LOMR revises the Flood
Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance
Study (FIS) reports, currently in effect for the listed communities.
The flood hazard determinations modified by each LOMR will be used to
calculate flood insurance premium rates for new buildings and their
contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at www.msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and 90 days have elapsed since that publication.
The Deputy Associate Administrator for Mitigation has resolved any
appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4105, and are in accordance with the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard information is the basis for the
floodplain management measures that the community is required either to
adopt or to show evidence of being already in effect in order to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    This new or modified flood hazard information, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be

construed to mean that the community must change any existing
ordinances that are more stringent in their floodplain management
requirements. The community may at any time enact stricter requirements
of its own or pursuant to policies established by other Federal, State,
or regional entities.
    This new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: June 25, 2015.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

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                                                             Chief executive officer of       Community map           Effective date of       Community
          State and county            Location and case No.           community                repository               modification             No.
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Alabama: Shelby (FEMA Docket No.: B- Unincorporated areas    The Honorable Rick          Shelby County           June 1, 2015..............       010191
 1505).                               of Shelby County (14-   Shepherd, Chairman,         Engineer's Office,
                                      04-A927P).              Shelby County Board of      506 Highway 70,
                                                              Commissioners, 200 West     Columbiana, AL 35051.
                                                              College Street,
                                                              Columbiana, AL 35051.
Colorado:
    Douglas (FEMA Docket No.: B-     Unincorporated areas    The Honorable Jill          Douglas County Public   June 12, 2015.............       080049
     1508).                           of Douglas County (14-  Repella, Chair, Douglas     Works Department,
                                      08-0892P).              County Board of             Engineering Division,
                                                              Commissioners, 100 3rd      100 3rd Street,
                                                              Street, Castle Rock, CO     Castle Rock, CO 80104.
                                                              80104.
    Ouray (FEMA Docket No.: B-1505)  Town of Ridgway (14-08- The Honorable John Clark,   Town Hall, 201 North    May 29, 2015..............       080138
                                      1315P).                 Mayor, Town of Ridgway,     Railroad Street,
                                                              P.O. Box 10, Ridgway, CO    Ridgway, CO 81432.
                                                              81432.
Florida
    Manatee (FEMA Docket No.: B-     Unincorporated areas    The Honorable Larry         Manatee County          June 5, 2015..............       120153
     1505).                           of Manatee County (14-  Bustle, Chairman, Manatee   Building and
                                      04-8724P).              County Board of             Development Services
                                                              Commissioners, 1112         Department, 1112
                                                              Manatee Avenue West, 9th    Manatee Avenue, West
                                                              Floor, Bradenton, FL        Bradenton, FL 34205.
                                                              34205.
    Monroe (FEMA Docket No.: B-      City of Key West (14-   The Honorable Craig Cates,  Planning Department,    June 5, 2015..............       120168
     1508).                           04-A505P).              Mayor, City of Key West,    605A Simonton Street,
                                                              3126 Flagler Avenue, Key    Key West, FL 33040.
                                                              West, FL 33040.
Georgia: Columbia (FEMA Docket No.:  Unincorporated areas    The Honorable Ron C.        Columbia County         May 28, 2015..............       130059
 B-1505).                             of Columbia County      Cross, Chairman, Columbia   Planning Department,
                                      (15-04-1887P).          County Board of             603 Ronald Reagan
                                                              Commissioners, P.O. Box     Drive, Building B,
                                                              498, Evans, GA 30809.       1st Floor, Evans, GA
                                                                                30809.
Kentucky:
    Scott (FEMA Docket No.: B-1505)  City of Georgetown (14- The Honorable Everett       Planning Commission,    May 29, 2015..............       210208
                                      04-4874P).              Varney, Mayor, City of      230 East Main Street,
                                                              Georgetown, 100 Court       Georgetown, KY 40324.
                                                              Street, Georgetown, KY
                                                              40324.
    Scott (FEMA Docket No.: B-1505)  Unincorporated areas    The Honorable George        Scott County Building   May 29, 2015..............       210207
                                      of Scott County (14-    Lusby, Scott County         Inspections
                                      04-4874P).              Judge, 101 East Main        Department, 100 Court
                                                              Street, Georgetown, KY      Street, Georgetown,
                                                              40324.                      KY 40324.
Louisiana: Rapides (FEMA Docket      City of Alexandria (14- The Honorable Jacques M.    City Hall, 915 3rd      May 21, 2015..............       220146
 No.: B-1509).                        06-4775P).              Roy, Mayor, City of         Street, Alexandria,
                                                              Alexandria, P.O. Box 71,    LA 71301.
                                                              Alexandria, LA 71309.
Montana: Ravalli (FEMA Docket No.:   Unincorporated areas    The Honorable Jeff          Floodplain Map          June 8, 2015..............       300061
 B-1505).                             of Ravalli County (15-  Burrows, Chairman,          Repository, 215 South
                                      08-0109P).              Ravalli County Board of     4th Street, Suite A,
                                                              Commissioners, 215 South    Hamilton, MT 59840.
                                                              4th Street, Suite A,
                                                              Hamilton, MT 59840.
New Mexico: Bernalillo (FEMA Docket  Unincorporated areas    The Honorable Maggie Hart   Bernalillo County       May 12, 2015..............       350001
 No.: B-1509).                        of Bernalillo County    Stebbins, Chair,            Planning and
                                      (14-06-0924P).          Bernalillo County Board     Development Division,
                                                              of Commissioners, 1 Civic   111 Union Square
                                                              Plaza Northwest,            Southeast, Suite 100,
                                                              Albuquerque, NM 87102.      Albuquerque, NM 87102.
North Carolina:
    Cabarrus (FEMA Docket No.: B-    City of Harrisburg (14- The Honorable Steve         Planning Department,    February 26, 2015.........       370038
     1505).                           04-6011P).              Sciascia, Mayor, Town of    4100 Main Street,
                                                              Harrisburg, 4100 Mail       Harrisburg, NC 28075.
                                                              Street, Harrisburg, NC
                                                              28075.
    Durham (FEMA Docket No.: B-      City of Durham (14-04-  The Honorable William V.    Public Works            February 17, 2015.........       370086
     1505).                           4200P).                 Bell, Mayor, City of        Department, 101 City
                                                              Durham, 101 City Hall       Hall Plaza, Durham,
                                                              Plaza, Durham, NC 27701.    NC 27701.
    Guilford (FEMA Docket No.: B-    City of Greensboro (14- The Honorable Nancy         Central Library, 219    June 26, 2015.............       375351
     1508).                           04-9100P).              Vaughan, Mayor, City of     North Church Street,
                                                              Greensboro, P.O. Box        Greensboro, NC 27401.
                                                              3136, Greensboro, NC
                                                              27402.
    Iredell (FEMA Docket No.: B-     Town of Mooresville     The Honorable Miles         Planning Department,    March 5, 2015.............       370314
     1464).                           (14-04-4151P).          Atkins, Mayor, Town of      413 North Main
                                                              Mooresville, 413 North      Street, Mooresville,
                                                              Main Street, Mooresville,   NC 28115.
                                                              NC 28115.
    Union (FEMA Docket No.: B-1508)  Town of Weddington (14- The Honorable Bill Deter,   Planning Department,    June 22, 2015.............       370518
                                      04-7777P).              Mayor, Town of              1924 Weddington Road,
                                                              Weddington, 1924            Weddington, NC 28104.
                                                              Weddington Road,
                                                              Weddington, NC 28104.
    Union (FEMA Docket No.: B-1508)  Unincorporated areas    The Honorable Richard       Union County Planning   June 22, 2015.............       370234
                                      of Union County (14-    Helms, Chairman, Union      Department, 500 Main
                                      04-7777P).              County Board of             Street, Monroe, NC
                                                              Commissioners, 500 North    28112.
                                                              Main Street, Room 921,
                                                              Monroe, NC 28112.
Ohio:
    Franklin (FEMA Docket No.: B-    City of Columbus (14-   The Honorable Michael B.    Department of Public    April 22, 2015............       390170
     1509).                           05-8003P).              Coleman, Mayor, City of     Utilities, 1250
                                                              Columbus, 90 West Broad     Fairwood Avenue,
                                                              Street, 2nd Floor,          Columbus, OH 43206.
                                                              Columbus, OH 43215.

    Franklin (FEMA Docket No.: B-    City of Hilliard (14-   The Honorable Don           City Hall, 3800         April 22, 2015............       390175
     1509).                           05-8003P).              Schonhardt, Mayor, City     Municipal Way,
                                                              of Hilliard, 5171           Hilliard, OH 43026.
                                                              Northwest Parkway,
                                                              Hilliard, OH 43026.
    Franklin (FEMA Docket No.: B-    Unincorporated areas    The Honorable Marilyn       Franklin County         April 22, 2015............       390167
     1509).                           of Franklin County      Brown, President,           Economic Development
                                      (14-05-8003P).          Franklin County Board of    and Planning
                                                              Commissioners, 373 South    Department, 150 South
                                                              High Street, 26th Floor,    Front Street, Suite
                                                              Columbus, OH 43215.         10, Columbus, OH
                                                                                43215.
South Carolina:
    Beaufort (FEMA Docket No.: B-    Town of Bluffton (15-   The Honorable Lisa Sulka,   Growth Management       June 5, 2015..............       450251
     1505).                           04-2707P).              Mayor, Town of Bluffton,    Customer Service
                                                              20 Bridge Street,           Center, 20 Bridge
                                                              Bluffton, SC 29910.         Street, Bluffton, SC
                                                                                29910.
    Charleston (FEMA Docket No.: B-  Town of Mount Pleasant  The Honorable Linda Page    Town Hall, 100 Ann      June 1, 2015..............       455417
     1505).                           (15-04-0360P).          Mayor, Town of Mount        Edwards Lane, Mount
                                                              Pleasant, 100 Ann Edwards   Pleasant, SC 29464.
                                                              Lane, Mount Pleasant, SC
                                                              29464.
Texas:
    Bexar (FEMA Docket No.: B-1506)  City of San Antonio     The Honorable Ivy R.        Storm Water Division,   May 6, 2015...............       480045
                                      (14-06-0780P).          Taylor, Mayor, City of      1901 South Alamo
                                                              San Antonio, P.O. Box       Street, 2nd Floor,
                                                              839966, San Antonio, TX     San Antonio, TX 78204.
                                                              78283.
    Bexar (FEMA Docket No.: B-1506)  City of San Antonio     The Honorable Ivy R.        Storm Water Division,   May 6, 2015...............       480045
                                      (15-06-0882X).          Taylor, Mayor, City of      1901 South Alamo
                                                              San Antonio, P.O. Box       Street, 2nd Floor,
                                                              839966, San Antonio, TX     San Antonio, TX 78204.
                                                              78283.
    Dallas (FEMA Docket No.: B-      City of Lancaster (14-  The Honorable Marcus E.     City Hall, 211 North    June 1, 2015..............       480182
     1506).                           06-3046P).              Knight, Mayor, City of      Henry Street,
                                                              Lancaster, P.O. Box 940,    Lancaster, TX 75146.
                                                              Lancaster, TX 75146.
    Denton (FEMA Docket No.: B-      City of Frisco (14-06-  The Honorable Maher Maso,   City Hall, 6101 Frisco  May 4, 2015...............       480134
     1506).                           3421P).                 Mayor, City of Frisco,      Square Boulevard,
                                                              6101 Frisco Square          Frisco, TX 75034.
                                                              Boulevard, Frisco, TX
                                                              75034.
    Denton (FEMA Docket No.: B-      Town of Little Elm (14- The Honorable David         Town Hall, 100 West     May 4, 2015...............       481152
     1506).                           06-3421P).              Hillock, Mayor, Town of     Eldorado Parkway,
                                                              Little Elm, 100 West        Little Elm, TX 75068.
                                                              Eldorado Parkway, Little
                                                              Elm, TX 75068.
    Caldwell (FEMA Docket No.: B-    City of Martindale (13- The Honorable Doyle         City Hall, 409 Main     May 15, 2015..............       481587
     1506).                           06-3462P).              Mosier, Mayor, City of      Street, Martindale,
                                                              Martindale, P.O. Box 365,   TX 78655.
                                                              Martindale, TX 78655.
    Caldwell (FEMA Docket No.: B-    Unincorporated areas    The Honorable Ken Schawe,   Caldwell County,        May 15, 2015..............       480094
     1506).                           of Caldwell County      Caldwell County Judge,      Emergency Management
                                      (13-06-3462P).          110 South Main Street,      Office, 110 South
                                                              Room 201, Lockhart, TX      Main Street,
                                                              78644.                      Lockhart, TX 78644.
    Guadalupe (FEMA Docket No.: B-   Unincorporated areas    The Honorable Kyle          Guadalupe County,       May 15, 2015..............       480266
     1506).                           of Guadalupe County     Kutscher, Guadalupe         Emergency Management
                                      (13-06-3462P).          County Judge, 211 West      Office, 415 East
                                                              Court Street, Seguin, TX    Donegan Street,
                                                              78155.                      Seguin, TX 78155.
    Harris (FEMA Docket No.: B-      Unincorporated areas    The Honorable Ed M.         Harris County,          May 18, 2015..............       480287
     1506).                           of Harris County (15-   Emmett, Harris County       Emergency Management
                                      06-0108P).              Judge, 1001 Preston         Office, 1001 Preston
                                                              Street, Suite 911,          Street, Houston, TX
                                                              Houston, TX 77002.          77002.
    Tarrant (FEMA Docket No.: B-     City of Fort Worth (14- The Honorable Betsy Price,  Public Works            May 22, 2015..............       480596
     1506).                           06-4247P).              Mayor, City of Fort         Department, 1000
                                                              Worth, 1000 Throckmorton    Throckmorton Street,
                                                              Street, Fort Worth, TX      Fort Worth, TX 76102.
                                                              76102.
    Tarrant (FEMA Docket No.: B-     City of Keller (14-06-  The Honorable Mark          Public Works            June 6, 2015..............       480602
     1506).                           4310P).                 Mathews, Mayor, City of     Department, 1100 Bear
                                                              Keller, P.O. Box 770,       Creek Parkway,
                                                              Keller, TX 76244.           Keller, TX 76248.
Utah:
    Davis (FEMA Docket No.: B-1508)  City of Fruit Heights   The Honorable Don Carroll,  City Hall, 910 South    June 5, 2015..............       490045
                                      (14-08-1211P).          Mayor, City of Fruit        Mountain Road, Fruit
                                                              Heights, 910 South          Heights, UT 84307.
                                                              Mountain Road, Fruit
                                                              Heights, UT 84037.
    Davis (FEMA Docket No.: B-1508)  City of Kaysville (14-  The Honorable Steve A.      City Hall, 23 East      June 5, 2015..............       490046
                                      08-1178P).              Hiatt, Mayor, City of       Center Street,
                                                              Kaysville, 23 East Center   Kaysville, UT 84037.
                                                              Street, Kaysville, UT
                                                              84037.
    Davis (FEMA Docket No.: B-1508)  City of Kaysville (14-  The Honorable Steve A.      City Hall, 23 East      June 5, 2015..............       490046
                                      08-1211P).              Hiatt, Mayor, City of       Center Street,
                                                              Kaysville, 23 East Center   Kaysville, UT 84037.
                                                              Street, Kaysville, UT
                                                              84037.
Virginia:
    Albemarle (FEMA Docket No.: B-   Unincorporated areas    The Honorable Thomas C.     Albemarle County        June 3, 2015..............       510006
     1506).                           of Albemarle County     Foley, Albemarle County     Department of
                                      (14-03-0864P).          Executive, 401 Mclntire     Community
                                                              Road, Charlottesville, VA   Development, 401
                                                              22902.                      Mclntire Road,
                                                                                Charlottesville, VA
                                                                                22902.
    Fairfax (FEMA Docket No.: B-     Unincorporated areas    The Honorable Edward L.     Fairfax County,         June 5, 2015..............       510525
     1506).                           of Fairfax County (15-  Long, Jr., Fairfax County   Stormwater Planning
                                      03-0079P).              Executive, 12000            Division, 12000
                                                              Government Center           Government Center
                                                              Parkway, Fairfax, VA        Parkway, Fairfax, VA
                                                              22035.                      22035.
    Frederick (FEMA Docket No.: B-   City of Winchester (14- The Honorable Eden          Department of Public    May 21, 2015..............       510173
     1506).                           03-2926P).              Freeman, Manager, City of   Services, 15 North
                                                              Winchester, 15 North        Cameron Street,
                                                              Cameron Street,             Winchester, VA 22601.
                                                              Winchester, VA 22601.
    Loudoun (FEMA Docket No.: B-     Town of Leesburg (14-   The Honorable Kristen C.    Town Hall, 25 West      May 14, 2015..............       510091
     1506).                           03-1706P).              Umstattd, Mayor, Town of    Market Street,
                                                              Leesburg, 25 West Market    Leesburg, VA 20176.
                                                              Street, Leesburg, VA
                                                              20176.
    Loudoun (FEMA Docket No.: B-     Unincorporated areas    The Honorable Scott K.      Loudoun County          May 14, 2015..............       510090
     1506).                           of Loudoun County (14-  York, Chairman-at-Large,    Building and
                                      03-1706P).              Loudoun County Board of     Development,
                                                              Supervisors, P.O. Box       Department 1 Harrison
                                                              7000, Leesburg, VA 20177.   Street Southeast,
                                                                                Leesburg, VA 20175.
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[FR Doc. 2015-18283 Filed 7-24-15; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: November 17, 2008 (Volume 73, Number 222)]
[Notices]
[Page 67899]
[DOCID:fr17no08-94]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.

Extension:
    Rule 10b-17; OMB Control No. 3235-0476; SEC File No. 270-427.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for approval of extension of the existing
collection of information provided for in the following rule: Rule 10b-
17 (17 CFR 240.10b-17).
    Rule 10b-17 requires any issuer of a class of securities publicly
traded by the use of any means or instrumentality of interstate
commerce or of the mails or of any facility of any national securities
exchange to give notice of the following specific distributions
relating to such class of securities: (1) A dividend or other
distribution in cash or in kind other than interest payments on debt
securities; (2) a stock split or reverse stock split; or (3) a rights
or other subscription offering. Notice shall be either given to the
Financial Industry Regulatory Authority, Inc. as successor to the
National Association of Securities Dealers, Inc. or in accordance with
the procedures of the national securities exchange upon which the
securities are registered. The Commission may exempt an issuer of over-
the-counter (but not listed) securities from the notice requirement.
The requirements of 10b-17 do not apply to redeemable securities of
registered open-end investment companies or unit investment trusts.
    The information required by Rule 10b-17 is necessary for the
execution of the Commission's mandate under the Securities Exchange Act
of 1934 to prevent fraudulent, manipulative, and deceptive acts and
practices. The Commission has found that not requiring formal notices
of the types of distributions covered by Rule 10b-17 has led to a
number of abuses including purchasers not being aware of their rights
to such distributions. It is only through formal notice of the
distribution, including the date of the distribution, that current
holders, potential buyers, or potential sellers of the securities at
issue will know their rights to the distribution. Therefore, it is only
through formal notice that investors can make an informed decision as
to whether to buy or sell a security.
    There are approximately 4,052 respondents per year. These
respondents make approximately 17,262 responses per year. Each response
takes approximately 10 minutes to complete. Thus, the total compliance
burden per year is 2,877 burden hours.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to:
<EMAIL_ADDRESS>and (ii) Lewis W. Walker, Acting Director/Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted within 30
days of this notice.

    Dated: November 10, 2008.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-27237 Filed 11-14-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 39 (Wednesday, February 27, 2019)]
[Notices]
[Pages 6403-6405]
[FR Doc No: 2019-03413]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0298]

Quality Considerations for Continuous Manufacturing; Draft
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 draft guidance for industry entitled ``Quality
Considerations for Continuous Manufacturing.'' This draft guidance
provides information regarding FDA's current thinking on the quality
considerations for continuous manufacturing of small molecule, solid
oral drug products that are regulated by the Center for Drug Evaluation
and Research (CDER). The draft guidance describes several key quality
considerations and provides recommendations for how applicants should
address these considerations in new drug applications (NDAs),
abbreviated new drug applications (ANDAs), and supplemental NDAs and
ANDAs, for small molecule, solid oral drug products that are produced
via a continuous manufacturing process. FDA supports the development
and implementation of continuous manufacturing for drug substances and
all finished dosage forms where appropriate, including those submitted
in NDAs, ANDAs, drug master files, biologics license applications
(BLAs), and nonapplication over the counter products. Scientific
principles described in this draft guidance may also be applicable to
continuous manufacturing technologies used for these drugs. However,
this draft guidance is not intended to provide recommendations specific
to continuous manufacturing technologies used for biological products
under a BLA.

DATES: Submit either electronic or written comments on the draft
guidance by May 28, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and

identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-0298 for ``Quality Considerations for Continuous
Manufacturing.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sau L. Lee, Center for Drug Evaluation
and Research, Food and Drug Administration (HFD-600), 10903 New
Hampshire Ave., Bldg. 22, Rm. 2130, Silver Spring, MD 20993-0002, 301-
796-2905.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Quality Considerations for Continuous Manufacturing.'' The
draft guidance was prepared by CDER's Office of Pharmaceutical Quality,
which is committed to supporting and enabling pharmaceutical innovation
and modernization as part of the Agency's mission to protect and
promote public health. While the implementation of emerging technology,
such as continuous manufacturing, is critical to modernizing
pharmaceutical manufacturing and improving quality, FDA also recognizes
that innovative approaches to manufacturing may represent challenges to
industry and regulators. By the very nature of an approach being
innovative, a limited knowledge and experiential base about the
technology may exist. Pharmaceutical companies may have concerns that
using continuous manufacturing could result in delays while FDA
reviewers and investigators familiarize themselves with the new
technologies and determine how they fit within existing regulatory
approaches.
    This draft guidance provides information regarding FDA's current
thinking on the quality considerations for continuous manufacturing of
small molecule, solid oral drug products that are regulated by CDER.
The draft guidance describes several key quality considerations and
provides recommendations for how applicants should address these
considerations in NDAs, ANDAs, and supplemental NDAs and ANDAs, for
small molecule, solid oral drug products that are produced via a
continuous manufacturing process.
    The draft guidance takes into account the comments that were
submitted to Docket No. FDA-2017-N-2697 (``Submission of Proposed
Recommendations for Industry on Developing Continuous Manufacturing of
Solid Dosage Drug Products in Pharmaceutical Manufacturing;
Establishment of Public Docket''). FDA invites general comments on the
quality considerations described in the draft guidance, including
comments on control strategy, facility, and process validation
considerations for continuous manufacturing of small molecule, solid
oral drug products.
    In addition to this draft guidance, pharmaceutical manufacturers
with product-specific continuous manufacturing questions may submit a
proposal to the Emerging Technology program. Refer to FDA guidance for
industry, ``Advancement of Emerging Technology Applications for
Pharmaceutical Innovation and Modernization'' (September 2017) at
<EMAIL_ADDRESS>    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Quality
Considerations for Continuous Manufacturing.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Additional Issues for Consideration

    In addition to comments on the draft guidance generally, FDA is
requesting comments and related supporting information on the following
topics: (1) Data storage and handling from process analytical
technology systems, (2) potential approaches for situations where
direct attribute measurement is not possible (e.g., low-dose
compounds), (3) contract manufacturers employing continuous
manufacturing, (4) risk-based reporting of routine model maintenance
and updates, and (5) statistical approaches using large samples (e.g.,
Large N). FDA is seeking public comment on topics for potential
inclusion in the final guidance or additional guidance and any other
alternative approaches.

III. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
The collections of information in 21 CFR parts 210-211 have been
approved under OMB control number 0910-0139. The submission of INDs
under 21 CFR 312.23 is approved by OMB control

number 0910-0014. The submission of BLAs under 21 CFR 601.2 and 601.12
is approved by OMB control number 0910-0338. The submission of NDAs and
ANDAs under 21 CFR 314.50, 314.70, 314.71, 314.94, and 314.97 is
approved by OMB control number 0910-0001. The information to be
included in a meeting request for a product submitted in an IND, BLA,
or NDA is approved by OMB control number 0910-0429 (``Guidance for
Industry on Formal Meetings Between the FDA and Sponsors or
Applicants'' (December 2017)). Information to be included in a meeting
request for a product submitted in an ANDA is approved by OMB control
number 0910-0797 (``Guidance on Controlled Correspondence Related to
Generic Drug Development'' (December 2015)).

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: February 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03413 Filed 2-26-19; 8:45 am]
 BILLING CODE 4164-01-P


% Mosquitocide 1.5 h/day dermal exposure
% Dose to reach average cpfos conc in blood = 0.004 ug/L
% Sept 1, 2016
% Cecilia Tan

% Setting model parameters
use human_parameters_MRP
use preg_female_parameters
BWSW=1;		% Set BW to a fixed value
BWST=11;	 % Set BW for children 11 kg
PREG=0;		% Not pregnant
DZONE = 1;	% Turn dermal exposure on
KDIS = 0.0;	% Daily dissipation
TSTOP=504;	%Simulation time = 21 days work week

% Dermal exposure
SAF=0.5;	 	% Fraction of skin in contact with chlorpyrifos.
FAD=1;     	% Fraction of dose available to be absorbed. Values of <1 could be used if pesticide is encapsulated.
%DERM =3580;		% dose in ug/kg
DERM = 14.9;
D3=7;  %DAYS/WEEK
P2=1.5; %HRS/DAY
S2=0 ;%OFFSET FROM 0 START TIME (EG IF YOU WANT TO MODEL FROM MIDNIGHT, BUT DOSE AT 8 AM)
W2=21; %21 day exposure

prepare @clear@all
start @NoCallback
simall = [_time _rbcce _urinetcpy _cv*350.6 _cvo*334.5 _blauc*350.6 _blauco*334.5 _blaucavg*350.6 _blaucoavg*334.5];	%conc unit = ug/L

save simall @file='mosquitocide_dermal_child_cc' @format=ascii


[Federal Register Volume 86, Number 84 (Tuesday, May 4, 2021)]
[Notices]
[Page 23774]
[FR Doc No: 2021-09351]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-334, OMB Control No. 3235-0380]

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Form F-10.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form F-10 (17 CFR 239.40) is a registration statement under the
Securities Act of 1933 (15 U.S.C. 77a et seq.) that may be used by a
foreign private issuer that: Is incorporated or organized in Canada;
has been subject to, and in compliance with, Canadian reporting
requirements for at least 12 months; and has an aggregate market value
of common stock held by non-affiliates of at least $75 million. The
purpose of this information collection is to permit verification of
compliance with securities law requirements and assure the public
availability of such information. We estimate that Form F-10 takes
28.98 hours per response and is filed by 77 respondents. We further
estimate that 25% of the 28.98 hours per response (7.25 hours) is
prepared by the issuer for an annual reporting burden of 558 hours
(7.25 hours per response x 77 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549 or send an email to:
<EMAIL_ADDRESS>
    Dated: April 29, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09351 Filed 5-3-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 81 (Monday, April 27, 2020)]
[Notices]
[Pages 23367-23369]
[FR Doc No: 2020-08894]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1027]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Infant Formula Recall Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection provisions in FDA's
infant formula recall regulations.

DATES: Submit either electronic or written comments on the collection
of information by June 26, 2020.

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 June 26, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 26, 2020. 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 No.
FDA-2014-N-1027 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Infant Formula Recall
Regulations.'' 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.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.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD

20852,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Infant Formula Recall Regulations--21 CFR 107.230, 107.240, 107.250,
107.260, and 107.280

OMB Control Number 0910-0188--Extension

    Section 412(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350a(e)) (the FD&C Act) provides that if the manufacturer of an
infant formula has knowledge that reasonably supports the conclusion
that an infant formula processed by that manufacturer has left its
control and may not provide the nutrients required in section 412(i) of
the FD&C Act or is otherwise adulterated or misbranded, the
manufacturer must promptly notify the Secretary of Health and Human
Services (the Secretary). If the Secretary determines that the infant
formula presents a risk to human health, the manufacturer must
immediately take all actions necessary to recall shipments of such
infant formula from all wholesale and retail establishments, consistent
with recall regulations and guidelines issued by the Secretary. Section
412(f)(2) of the FD&C Act states that the Secretary shall by regulation
prescribe the scope and extent of recalls of infant formula necessary
and appropriate for the degree of risk to human health presented by the
formula subject to recall. FDA's infant formula recall regulations in
part 107 (21 CFR part 107) implement these statutory provisions.
    Section 107.230 requires each recalling firm to conduct an infant
formula recall with the following elements: (1) Evaluate the hazard to
human health, (2) devise a written recall strategy, (3) promptly notify
each affected direct account (customer) about the recall, and (4)
furnish the appropriate FDA district office with copies of these
documents. If the recalled formula presents a risk to human health, the
recalling firm must also request that each establishment that sells the
recalled formula post (at point of purchase) a notice of the recall and
provide FDA with a copy of the notice. Section 107.240 requires the
recalling firm to conduct an infant formula recall with the following
elements: (1) Notify the appropriate FDA district office of the recall
by telephone within 24 hours, (2) submit a written report to that
office within 14 days, and (3) submit a written status report at least
every 14 days until the recall is terminated. Before terminating a
recall, the recalling firm is required to submit a recommendation for
termination of the recall to the appropriate FDA district office and
wait for FDA's written concurrence (Sec.  107.250). Where the recall
strategy or implementation is determined to be deficient, FDA may
require the firm to change the extent of the recall, carry out
additional effectiveness checks, and issue additional notifications
(Sec.  107.260). In addition, to facilitate location of the product
being recalled, the recalling firm is required to maintain distribution
records for at least 1 year after the expiration of the shelf life of
the infant formula (Sec.  107.280).
    The reporting and recordkeeping requirements described previously
are designed to enable FDA to monitor the effectiveness of infant
formula recalls in order to protect babies from infant formula that may
be unsafe because of contamination, nutritional inadequacy, or is
otherwise adulterated or misbranded. FDA uses the information collected
under these regulations to help ensure that such products are quickly
and efficiently removed from the market.
    Description of Respondents: Respondents to this collection of
information are manufacturers of infant formula who are for-profit
businesses in the private sector.
    FDA estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
----------------------------------------------------------------------------------------------------------------
107.230; Elements of infant                    2               1               2           4,450           8,900
 formula recall.................
107.240; Notification                          2               1               2           1,482           2,964
 requirements...................
107.250; Termination of infant                 2               1               2             120             240
 formula recall.................
107.260; Revision of an infant                 1               1               1             625             625
 formula recall.................
                                 -------------------------------------------------------------------------------
    Total \2\...................  ..............  ..............  ..............  ..............          12,729
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ No burden has been estimated for the recordkeeping requirement in Sec.   107.280 because these records are
  maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula
  distribution records for the prescribed period as a matter of routine business practice.

    The reporting and third-party disclosure burden estimates are based
on FDA's records, which show that there are six manufacturers of infant
formula and that there have been, on average, two infant formula
recalls per year for the past 3 years. Based on this information, we
estimate that there are, on average, approximately two infant formula
recalls per year.
    Thus, we estimate that two respondents conduct recalls annually
pursuant to Sec. Sec.  107.230, 107.240, and 107.250. The estimated
number of respondents for Sec.  107.260 is minimal because we seldom
use this section; therefore, we estimate that there are one or fewer
respondents annually for Sec.  107.260. The estimated number of hours
per response is an average based on our experience and information from
firms that have conducted recalls. FDA estimates that two respondents
will conduct infant formula recalls under Sec.  107.230 and that it
takes a respondent 4,450 hours to comply with the requirements of that
section, for a total of 8,900 hours. FDA estimates that two respondents
conduct infant formula recalls under Sec.  107.240 and that it takes a
respondent 1,482 hours to comply with the requirements of that section,
for a total of 2,964 hours. FDA estimates that two respondents submit
recommendations for termination of infant formula recalls under Sec.
107.250 and that it takes a respondent 120 hours to comply with the
requirements of that section, for a total of 240 hours. Finally, FDA
estimates that one respondent needs to carry out additional
effectiveness checks and issue additional notifications, for a total of
625 hours. Therefore, the total annual burden hours for reporting is
12,729 hours (8,900 + 2,964 + 240 + 625).
    Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources
necessary to comply with a collection of information are excluded from
the burden estimate if the reporting, recordkeeping, or disclosure
activities needed to comply are usual and customary because they would
occur in the normal course of activities. No burden has been estimated
for the recordkeeping requirement in Sec.  107.280 because these
records are maintained as a usual and customary part of normal business
activities. Manufacturers keep infant formula distribution records for
the prescribed period as a matter of routine business practice.

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual   Average burden
    21 CFR section; activity        respondents         per         disclosures   per disclosure    Total hours
                                                    respondent
----------------------------------------------------------------------------------------------------------------
107.230; Elements of infant                    2               1               2              50             100
 formula recall.................
107.260; Revision of an infant                 1               1               1              25              25
 formula recall.................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             125
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 2 reports FDA's third-party disclosure burden estimates for
Sec. Sec.  107.230 and 107.260. The estimated burden hours per
disclosure is an average based on FDA's experience. The third-party
disclosure burden in Sec.  107.230 is the requirement to promptly
notify each affected direct account (customer) about the recall, and if
the recalled formula presents a risk to human health, the recalling
firm must also request that each establishment that sells the recalled
formula post a notice of the recall at the point of purchase. FDA
estimates that two respondents conduct infant formula recalls under
Sec.  107.230 and that it takes a respondent 50 hours to comply with
the third-party disclosure requirements of that section, for a total of
100 hours. The third-party disclosure burden in Sec.  107.260 is the
requirement to issue additional notifications where the recall strategy
or implementation is determined to be deficient. FDA estimates that one
respondent issues additional notifications under Sec.  107.260 and that
it takes a respondent 25 hours to comply with the third-party
disclosure requirements of that section, for a total of 25 hours. The
total annual third-party disclosure burden is 125 hours (100 + 25).
    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: April 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08894 Filed 4-24-20; 8:45 am]
 BILLING CODE 4164-01-P