[Federal Register Volume 76, Number 20 (Monday, January 31, 2011)]
[Notices]
[Pages 5386-5387]
[FR Doc No: 2011-1989]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0254; formerly Docket No. 2001D-0037]

Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of
Whole Blood and Blood Components Intended for Transfusion; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry: Pre-
Storage Leukocyte Reduction of Whole Blood and Blood Components
Intended for Transfusion'' dated January 2011. The draft guidance
document provides blood establishments with recommendations for pre-
storage leukocyte reduction of Whole Blood and blood components
intended for transfusion, including recommendations for validation and
quality control monitoring of the leukocyte reduction process. This
second draft guidance document incorporates revisions after reviewing
comments on the January 2001 draft. This draft guidance replaces the
draft guidance of the same title dated January 2001. This draft
guidance, when

finalized, will supersede the FDA memorandum issued on May 29, 1996,
entitled ``Recommendations and Licensure Requirements for Leukocyte-
Reduced Blood Products.''

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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 2, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. 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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised, second draft
document entitled ``Guidance for Industry: Pre-Storage Leukocyte
Reduction of Whole Blood and Blood Components Intended for
Transfusion'' dated January 2011. The draft guidance document provides
blood establishments with recommendations for pre-storage leukocyte
reduction of Whole Blood and blood components intended for transfusion,
including recommendations for validation and quality control monitoring
of the leukocyte reduction process. The draft guidance provides
information to assist licensed blood establishments for submitting
biologics license application supplements to include leukocytes reduced
components. This second draft guidance document incorporates revisions
after reviewing comments on the January 2001 draft, and in
consideration of additional public discussions held at the June and
December 2001 meetings of the Blood Products Advisory Committee and the
July 2005 public workshop entitled ``Update on Leukocyte Reduction of
Blood and Blood Components.'' This draft guidance replaces the draft
guidance of the same title dated January 2001 (January 31, 2001, 66 FR
8410). The draft guidance, when finalized, will supersede the FDA
memorandum issued on May 29, 1996, entitled ``Recommendations and
Licensure Requirements for Leukocyte-Reduced Blood Products.''
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA'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 requirement of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 607 have been approved under
OMB control number 0910-0052; the collections of information in 21 CFR
606.100(b), 606.100(c), and 606.121 have been approved under OMB
control number 0910-0116; the collections of information in 21 CFR
211.192 and 211.198 have been approved under OMB control number 0910-
0139; and the collections of information in 21 CFR 601.12 and 610.60
have been approved under OMB control number 0910-0338.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1989 Filed 1-28-11; 8:45 am]
BILLING CODE 4160-01-P


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

1. Agency/ Subagency originating request EPA; Office of Prevention, Pesticides & Toxic Substances 2. OMB control number b. G None a. 2 0 7 0  0 0 3 0 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. O Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. O Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes O No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. O Three years from approval date b. G Other Specify: / /___

7. Title TSCA Section 12( b) Notification of Chemical Exports 8. Agency form number( s) ( If applicable) EPA ICR # 0795.10 9. Keywords Environmental Protection; Chemicals; Hazardous Substances; Exports; Imports; Recordkeeping and Reporting Requirements 10. Abstract TSCA section 12( b) requires that any person who intends to export a chemical substance that is regulated under TSCA section 4, 5, 6 and/ or 7 to submit notification of such a proposed export to EPA. Upon receipt of notification, EPA will advise the government of the importing country about the U. S. regulatory action. TSCA section 12( b) affects all domestic exporters.

11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 350 b. Total annual responses 11,000 1. Percentage of these responses collected electronically 0 % c. Total hours requested 10,400 d. Current OMB inventory 3,800 e. Difference + 6,600 f. Explanation of difference 1. Program Change 2. Adjustment + 6,600 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X")

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

17. Statistical methods Does this information collection employ statistical methods? G Yes O No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Angela F. Hofmann, Director, Regulatory Coordination Staff Phone: 202 260 2922 OMB 83 I 10/ 95 RECEIVED OPPT NCIC 2003 July 25 11: 04AM OPPT 2003 0039 0001 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

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

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

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

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

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

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

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

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

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

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

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

Signature of Program Official Angela F. Hofmann, Director Regulatory Coordination Staff ( OPPTS) Date Signature of Senior Official or designee Joseph Retzer, Director Regulatory Information Division Office of Regulatory Management and Evaluation ( OPPE) Date OMB 83 I 10/ 95


[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Notices]
[Pages 64609-64610]
[FR Doc No: 2020-22517]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2020-69]

Petition for Exemption; Summary of Petition Received; University
of North Dakota University and University of North Dakota Aerospace
Foundation

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before November 2, 2020.

ADDRESSES: Send comments identified by docket number FAA-2020-0782
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in

Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Linda Lane<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on October 2, 2020.
Brandon Roberts,
Executive Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2020-0782.
    Petitioner: University of North Dakota (UND) and University of
North Dakota Aerospace Foundation (UNDAF).
    Sections of 14 CFR Affected: Sec. Sec.  141.11(b) and 141.63(a)(2)
and (3).
    Description of Relief Sought: The University of North Dakota and
the University of North Dakota Aerospace Foundation are petitioning for
exemption from 14 CFR part 141, Sec. Sec.  141.11(b) and 141.63(a)(2)
and (3), to the extent necessary to permit UND and UNDAF to conduct
flight training utilizing one syllabus for both an instrument rating
airplane and commercial pilot certificate and maintain part 141
examining authority. This syllabus will meet all appropriate training
content and aeronautical experience requirements provided in part 141,
Appendices C and D, and will not have reduced training times.

[FR Doc. 2020-22517 Filed 10-9-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 153 (Friday, August 8, 2014)]
[Notices]
[Pages 46500-46501]
[FR Doc No: 2014-18755]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-51]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before August 28, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0481 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC, 20951.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 4, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2014-0481.
    Petitioner: Trudeau, Douglas.
    Section of 14 CFR 45.23(b), 61.113(a) and (b), 91.7(a), 91.9(b)(2),
91.103(b), 91.109, 91.119, 91.121, 91.151(a), 91.203(a) and (b),
91.405(a), 91.407(a)(1), 91.409(a)(2), and 91.417(a) and (b).
    Description of Relief Sought: The petitioner is seeking an
exemption to commercially operate his small ultra light weight UAS for
academic community awareness, real estate operations, enhancement of
real estate listing videos for homeowners that cannot afford expensive
manned aircraft for the same purpose, and to benefit/

stimulate attraction to the metro Tucson area.

[FR Doc. 2014-18755 Filed 8-7-14; 8:45 am]
BILLING CODE 4910-13-P