[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37321-37323]
[FR Doc No: 2019-16243]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0579]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Biological Products: Reporting of Biological Product
Deviations and Human Cells, Tissues, and Cellular and Tissue-Based
Deviations in Manufacturing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 the information collection requirements
relating to the reporting of biological product deviations and human
cells, tissues, and cellular and tissue-based product (HCT/P)
deviations in manufacturing, and Forms FDA 3486 and 3486A.July 31, 2019

DATES: Submit electronic or written comments on the collection of
information by September 30, 2019.

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 September 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 30, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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-2013-N-0579 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Biological Products: Reporting of
Biological Product Deviations and Human Cells, Tissues, and Cellular
and Tissue-Based Deviations in Manufacturing; Forms FDA 3486 and
3486A.'' 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 http://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 http://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: http://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 http://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: Domini Bean, 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. 3501-3520), 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.

Biological Products: Reporting of Biological Product Deviations and
Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations
in Manufacturing; Forms FDA 3486 and 3486A

OMB Control Number 0910-0458--Extension

    Under section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262), all biological products, including human blood and blood
components, offered for sale in interstate commerce must be licensed
and meet standards, including those prescribed in the FDA regulations,
designed to ensure the continued safety, purity, and potency of such
products. In addition, under section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases between
the States or possessions or from foreign countries into the States or
possessions. Further, the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351) provides that drugs and devices (including human
blood and blood components) are adulterated if they do not conform with
current good manufacturing practice (CGMP) assuring that they meet the
requirements of the FD&C Act. Establishments manufacturing biological
products, including human blood and blood components, must comply with
the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts
211, 606, and 820)) and current good tissue practice (CGTP) regulations
(part 1271 (21 CFR part 1271)) as appropriate. FDA regards biological
product deviation (BPD) reporting and HCT/P deviation reporting to be
an essential tool in its directive to protect public health by
establishing and maintaining surveillance programs that provide timely
and useful information.
    Section 600.14 (21 CFR 600.14), in brief, requires the manufacturer
who holds the biological product license, for other than human blood
and blood components, and who had control over a distributed product
when the deviation occurred, to report to the Center for Biologics
Evaluation and Research (CBER) or to the Center for Drug Evaluation and
Research (CDER) as soon as possible but at a date not to exceed 45
calendar days after acquiring information reasonably suggesting that a
reportable event has occurred. Section 606.171, in brief, requires
licensed manufacturers of human blood and blood components, including
Source Plasma, unlicensed registered blood establishments, and
transfusion

services, who had control over a distributed product when the deviation
occurred, to report to CBER as soon as possible but at a date not to
exceed 45 calendar days after acquiring information reasonably
suggesting that a reportable event has occurred. Similarly, Sec.
1271.350(b), in brief, requires HCT/P establishments that manufacture
non-reproductive HCT/Ps described in Sec.  1271.10 to investigate and
report to CBER all HCT/P deviations relating to a distributed HCT/P
that relates to the core CGTP requirements, if the deviation occurred
in the establishment's facility or in a facility that performed a
manufacturing step for the establishment under contract, agreement or
other arrangement. Form FDA 3486 is used to submit BPD reports and HCT/
P deviation reports.
    Respondents to this collection of information are: (1) Licensed
manufacturers of biological products other than human blood and blood
components, (2) licensed manufacturers of blood and blood components
including Source Plasma, (3) unlicensed registered blood
establishments, (4) transfusion services, and (5) establishments that
manufacture non-reproductive HCT/Ps regulated solely under section 361
of the PHS Act as described in Sec.  1271.10. The number of respondents
and total annual responses are based on the BPD reports and HCT/P
deviation reports FDA received in fiscal year 2018. The number of
licensed manufacturers and total annual responses under Sec.  600.14
include the estimates for BPD reports submitted to both CBER and CDER.
Based on the information from industry, the estimated average time to
complete a deviation report is 2 hours, which includes a minimal one-
time burden to create a user account for those reports submitted
electronically. The availability of the standardized report form, Form
FDA 3486, and the ability to submit this report electronically to CBER
(CDER does not currently accept electronic filings) further streamlines
the report submission process.
    CBER has developed a Web-based addendum to Form FDA 3486 (Form FDA
3486A) to provide additional information when a BPD report has been
reviewed by FDA and evaluated as a possible recall. The additional
information requested includes information not contained in the Form
FDA 3486 such as: (1) Distribution pattern; (2) method of consignee
notification; (3) consignee(s) of products for further manufacture; (4)
additional product information; (5) updated product disposition; and
(6) industry recall contacts. This information is requested by CBER
through email notification to the submitter of the BPD report. This
information is used by CBER for recall classification purposes. CBER
estimates that 5 percent of the total BPD reports submitted to CBER
would need additional information submitted in the addendum. CBER
further estimates that it would take between 10 to 20 minutes to
complete the addendum. For calculation purposes, CBER is using 15
minutes.
    Activities such as investigating, changing standard operating
procedures or processes, and followup are currently required under 21
CFR parts 211 (approved under OMB control number 0910-0139), 606
(approved under OMB control number 0910-0116), 820 (approved under OMB
control number 0910-0073). and 1271 (approved under OMB control number
0910-0543) and, therefore, are not included in the burden calculation
for the separate requirement of submitting a deviation report to FDA.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of                        Average
               21 CFR section                       FDA  form No.            Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.14; Reporting of product deviations by   3486                                     93            6.14             571             2.0           1,142
 licensed manufacturers.
606.171; Reporting of product deviations by  3486                                  1,937          23.847          46,192             2.0          92,384
 licensed manufacturers, unlicensed
 registered blood establishments, and
 transfusion services.
1271.350(b); Reporting requirements (human   3486                                     93            2.61             243             2.0             486
 cells, tissues, and cellular and tissue-
 based products).
1271.350(b) (CBER addendum report).........  3486A \2\                               102           22.76           2,322            0.25           580.5
                                                                         -------------------------------------------------------------------------------
    Total..................................  ...........................  ..............  ..............          49,328  ..............        94,592.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of the number of respondents ((1,937 + 93) x 0.05 = 102) and total annual responses to CBER ((46,192 + 243) x 0.05 = 2,322).

    Our estimated burden for the information collection reflects an
overall increase of 739 hours and a corresponding increase of 398
responses. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.

    Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16243 Filed 7-30-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 38 (Tuesday, February 28, 2017)]
[Proposed Rules]
[Pages 12071-12074]
[FR Doc No: 2017-03712]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0124; Directorate Identifier 2016-NM-166-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model BD-100-1A10 airplanes. This proposed AD
was prompted by several reports of nose wheel steering failures in
service. This proposed AD would require a part verification and
replacement of certain steering manifolds. We are proposing this AD to
address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by April 14, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0124; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Assata Dessaline, Aerospace Engineer,
Avionics and Services Branch, ANE-172, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2017-0124;
Directorate Identifier 2016-NM-166-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2016-24, dated August 19, 2016 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Bombardier, Inc. Model BD-100-1A10
airplanes. The MCAI states:

    Several cases of nose wheel steering failures have been reported
in service. In one case, the aeroplane experienced uncommanded nose
wheel steering, resulting in a runway excursion.
    Investigations found the presence of moisture inside the
electrical stage of the electro-hydraulic servo valve (EHSV) unit,
which resulted in low insulation resistance and corrosion. This
condition, in combination with a steering selector valve failure,
could result in uncommanded nose wheel steering, which could lead to
a runway excursion at high speed.
    This [Canadian] AD mandates the replacement of the steering
manifold to provide better moisture ingress protection of the EHSV.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0124.

Related Service Information Under 1 CFR Part 51

    We reviewed Bombardier Service Bulletin 100-32-25, Revision 01,
dated June 30, 2015. This service information describes procedures for
a one-time verification of the steering manifold part number and
replacement of the steering manifold and mod plate. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 161 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                                     Estimated Costs
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              Action                      Labor cost                 Parts cost                   Cost per  product            Cost on U.S. operators
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Steering manifold part              1 work-hour x $85 per  $0............................  $85...........................  $13,685
 verification.                       hour = $85.
Replacement of steering manifold..  Up to 4 work-hours x   Up to $18,522.................  Up to $18,862.................  Up to $3,036,782
                                     $85 per hour = $340.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Bombardier, Inc.: Docket No. FAA-2017-0124; Directorate Identifier
2016-NM-166-AD.

(a) Comments Due Date

    We must receive comments by April 14, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model BD-100-1A10 airplanes,
certificated in any category, as identified in Bombardier Service
Bulletin 100-32-25, Revision 01, dated June 30, 2015.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Reason

    This AD was prompted by several reports of nose wheel steering
failures in service. We are issuing this AD to prevent moisture from
entering the electrical stage of the electro-hydraulic servo valve
(EHSV), which could lead to uncommanded nose wheel steering, and a
consequent runway excursion at high speed.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Verification and Replacement of Steering Manifold

    Within 48 months after the effective date of this AD, do a one-
time inspection to determine the part number of the steering
manifold, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 100-32-25, Revision 01, dated June 30,
2015.
    (1) If the airplane has steering manifold part number (P/N)
40750-103, within 48 months after the effective date of this AD,
write ``SB100-32-018'' on the nose landing gear (NLG) mod plate. If
the mod plate is missing or full, within 48 months after the
effective date of this AD, install a new plate, in accordance with
the Accomplishment Instructions of Bombardier Service Bulletin 100-
32-25, Revision 01, dated June 30, 2015.
    (2) If the airplane has steering manifold P/N 40750-101, within
48 months after the effective date of this AD, replace it in
accordance with the Accomplishment Instructions of Bombardier
Service Bulletin 100-32-25, Revision 01, dated June 30, 2015, and
write ``SB100-32-018'' on the NLG mod plate. If the mod plate is
missing or full, within 48 months after the effective date of this
AD, install a new plate, in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 100-32-25, Revision 01,
dated June 30, 2015.

(h) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using Bombardier Service Bulletin 100-32-25, dated
September 24, 2014.

(i) Parts Installation Prohibition

    As of the effective date of this AD, no person may install a
steering manifold, P/N 40750-101, on the nose landing gear assembly
of any airplane.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2016-24, dated August 19,
2016, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0124.
    (2) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 15, 2017.
Thomas Groves,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-03712 Filed 2-27-17; 8:45 am]
 BILLING CODE 4910-13-P


BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

								_

Joint Applications of		 )

		 )

DELTA AIR LINES, INC.,		 )

ATLANTIC SOUTHEAST AIRLINES, INC. and	 )

COMAIR, INC.		 )

		 )

and		 )	Docket OST-2000-8207

		 )

CZECH AIRLINES		 )

for statements of authorization		 )

pursuant to 14 C.F.R. Part 212		 )

(United States-Czech Republic blanket codesharing )

30-DAY NOTICE

Communications with respect to this document should be sent to:

Allan I. Mendelsohn			D. Scott Yohe

Constance O’Keefe				Senior Vice President - Government Affairs

MENDELSOHN & O’KEEFE		DELTA AIR LINES, INC.

1201 Connecticut Avenue, N.W.		1275 K Street, N.W.

Suite 8500					Washington, D.C. 20005

Washington, D.C. 20036<PHONE_NUMBER>                                  <PHONE_NUMBER>

						John Varley, Assistant General Counsel

Counsel for					James Coblin, Attorney

CZECH AIRLINES				DELTA AIR LINES, INC.

						Law Department #981

						1030 Delta Boulevard

						Atlanta, GA 30320

<PHONE_NUMBER>

						Robert E. Cohn

						Alexander Van der Bellen

						SHAW PITTMAN LLP

						2300 N. Street, N.W.

						Washington, D.C. 20037-1128

<PHONE_NUMBER>

						Counsel for

						DELTA AIR LINES, INC.

				ATLANTIC SOUTHEAST AIRLINES, INC.

May 2, 2002					COMAIR, INC.

BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

								_

Joint Applications of		 )

		 )

DELTA AIR LINES, INC.,		 )

ATLANTIC SOUTHEAST AIRLINES, INC. and	 )

COMAIR, INC.		 )

		 )

and		 )	Docket OST-2000-8207

		 )

CZECH AIRLINES		 )

for statements of authorization		 )

pursuant to 14 C.F.R. Part 212		 )

(United States-Czech Republic blanket codesharing )

30-DAY NOTICE

Pursuant to the blanket statement of authorization granted to Delta and CSA in the captioned docket, the carriers hereby submit this 30-day notice of additional codesharing.  Delta plans to display its “DL” designator code on flights operated by CSA between Prague and Venice, Italy.

Respectfully submitted,

/s/						/s/

Allan I. Mendelsohn	Robert E. Cohn

Constance O’Keefe 	Alexander Van der Bellen

MENDELSOHN & O’KEEFE	SHAW PITTMAN LLP

1201 Connecticut Avenue, N.W.	2300 N Street, N.W.

Suite 850	Washington, D.C. 20037-1128

Washington, D.C. 20036<PHONE_NUMBER>

(202) 775-0680

Counsel for	Counsel for

CZECH AIRLINES	DELTA AIR LINES, INC.

	ATLANTIC SOUTHEAST AIRLINES, INC.

	COMAIR, INC.

Footnote continued from previous page

Footnote continued on next page

30-Day Notice

Page   PAGE  2


[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19049-19050]
[FR Doc No: 2017-08303]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2066]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Certification of
Identity for Freedom of Information Act and Privacy Act Requests

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 25,
2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Certification of Identity for Freedom of Information Act and
Privacy Act Requests.'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Cappezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Certification of Identity for Freedom of Information Act and Privacy
Act Requests--OMB Control Number 0910--NEW

    In compliance with 44 U.S.C. 3507, FDA will submit to OMB a request
to review and approve a new collection of information: Certification of
Identity for Freedom of Information Act and Privacy Act Requests. This
new form provides the FDA with data necessary to identify an individual
requesting a particular record under the Freedom of Information Act
(FOIA) and the Privacy Act. The form is available at the following FDA
FOIA page at: https://www.fda.gov/RegulatoryInformation/FOI/default.htm, although if an individual requests one, we will send it by
mail or email. The FOIA grants the public a right to access Federal
records not normally prepared for public distribution. The Privacy Act
grants a right of access to members of the public who seek access to
one's own records that are maintained in an Agency's system of records
(i.e. the records are retrieved by that individual's name or other
personal identifier). The statutes overlap, and individuals who request
their own records are processed under both statutes. The Agency may
need to confirm that the individual making the FOIA or Privacy Act
request is indeed the same person named in the Agency records.
    Members of the public who wish to access particular records will be
asked for certain information: Name, citizenship status, social
security number, address, date of birth, place of birth, signature, and
date of signature.
    In the Federal Register of August 4, 2016 (81 FR 51455), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:
    As stated in table 1, the estimates are based on the following: The
number of FOIA and Privacy Act requests received by FDA each year that
require a certification of identity in order for FDA to process the
request. Of the 10,000 requests received per year, only a small number
require a certification of identity. In some cases, the requesters
provide their own certification of identity. Therefore, we have
estimated the number of affected individuals at 60 per year.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                      Number of
                  FDA form No.                       Number of      responses per     Total annual       Average burden per response       Total hours
                                                    respondents       respondent       responses
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3975............................................              60                1               60   0.17 (10 minutes).................              10
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08303 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P