[Federal Register Volume 81, Number 118 (Monday, June 20, 2016)]
[Notices]
[Pages 39929-39930]
[FR Doc No: 2016-14459]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-1026]

Medical Devices; Exemption From Premarket Notification: Method,
Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in
a Reagent Tablet Format; Republication

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; republication.

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SUMMARY: The Food and Drug Administration (FDA) is republishing in its
entirety a notice entitled ``Medical Devices; Exemption from Premarket
Notification: Method, Metallic Reduction, Glucose (Urinary, Non-
Quantitative) Test System in a Reagent Tablet Format'' that published
in the Federal Register on May 4, 2016 (81 FR 26802). FDA is
republishing to correct an inadvertent error in the Docket Number and
to announce a revised comment period. FDA is announcing that it has
received a petition requesting exemption from the premarket
notification requirements for a method, metallic reduction, glucose
(urinary, non-quantitative) test system in a reagent tablet format that
is intended to measure glucosuria (glucose in urine). Method, metallic
reduction, glucose (urinary, non-quantitative) test systems in a
reagent tablet format are used in the diagnosis and treatment of
carbohydrate metabolism disorders including diabetes mellitus,
hypoglycemia, and hyperglycemia. FDA is publishing this notice to
obtain comments in accordance with procedures established by the Food
and Drug Administration Modernization Act of 1997 (FDAMA).

DATES: Submit either electronic or written comments by July 20, 2016.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-P-1026 for ``Medical Devices; Exemption From Premarket
Notification: Method, Metallic Reduction, Glucose (Urinary, Non-
Quantitative) Test System in a Reagent Tablet Format.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ana Loloei Marsal, Center for Devices
and Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4552, Silver Spring, MD 20993-0002, 301-
796-8774<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295),
as amended by the Safe Medical Devices Act of 1990 (Pub. L. 101-629),
devices are to be classified into class I (general controls) if there
is information showing that the general controls of the FD&C Act are
sufficient to assure safety and effectiveness; into class II (special
controls) if general controls, by themselves, are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide such
assurance; and into

class III (premarket approval) if there is insufficient information to
support classifying a device into class I or class II and the device is
a life sustaining or life supporting device, or is for a use which is
of substantial importance in preventing impairment of human health or
presents a potential unreasonable risk of illness or injury.
    Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the FD&C Act through the
issuance of classification regulations into one of these three
regulatory classes. Devices introduced into interstate commerce for the
first time on or after May 28, 1976 (generally referred to as
postamendments devices), are classified through the premarket
notification process under section 510(k) of the FD&C Act (21 U.S.C.
360(k)). Section 510(k) of the FD&C Act and the implementing
regulations, 21 CFR part 807, require persons who intend to market a
new device to submit a premarket notification (510(k)) containing
information that allows FDA to determine whether the new device is
``substantially equivalent'' within the meaning of section 513(i) of
the FD&C Act to a legally marketed device that does not require
premarket approval.
    On November 21, 1997, the President signed into law FDAMA (Pub. L.
105-115). Section 206 of FDAMA, in part, added a new section, 510(m),
to the FD&C Act. Section 510(m)(1) of the FD&C Act requires FDA, within
60 days after enactment of FDAMA, to publish in the Federal Register a
list of each type of class II device that does not require a report
under section 510(k) of the FD&C Act to provide reasonable assurance of
safety and effectiveness. Section 510(m) of the FD&C Act further
provides that a 510(k) will no longer be required for these devices
upon the date of publication of the list in the Federal Register. FDA
published that list in the Federal Register of January 21, 1998 (63 FR
3142).
    Section 510(m)(2) of the FD&C Act provides that 1 day after date of
publication of the list under section 510(m)(1), FDA may exempt a
device on its own initiative or upon petition of an interested person
if FDA determines that a 510(k) is not necessary to provide reasonable
assurance of the safety and effectiveness of the device. This section
requires FDA to publish in the Federal Register a notice of intent to
exempt a device, or of the petition, and to provide a 30-day comment
period. Within 120 days of publication of this document, FDA must
publish in the Federal Register its final determination regarding the
exemption of the device that was the subject of the notice. If FDA
fails to respond to a petition under this section within 180 days of
receiving it, the petition shall be deemed granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance the Agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff'' (Ref. 1).

III. Proposed Class II Device Exemptions

    FDA has received the following petition requesting an exemption
from premarket notification for a class II device: Martin O'Connor,
Germaine Laboratories, Inc., 11030 Wye Dr., San Antonio, TX 78217, for
its Method, Metallic Reduction, Glucose (urinary, non-quantitative)
classified under 21 CFR 862.1340. FDA previously announced that it
received this petition in a notice entitled ``Medical Devices;
Exemption from Premarket Notification: Method, Metallic Reduction,
Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet
Format'' that appeared in the Federal Register of May 4, 2016 (81 FR
26802). The document was published with the incorrect docket number.
This notice includes the correct docket number for the petition.

IV. Reference

    The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at http://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. ``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff,'' February 1998,
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf).

    Dated: June 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14459 Filed 6-17-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68794-68796]
[FR Doc No: 2022-24899]

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DEPARTMENT OF TRANSPORTATION

[Docket No. DOT-OST-2022-0130]

Office of the Assistant Secretary for Research and Technology
(OST-R); Agency Information Collection Activities: Comment Request;
Data Security Requirements for Accessing Confidential Data

AGENCY: Bureau of Transportation Statistics (BTS) Office of the
Assistant Secretary for Research and Technology (OST-R), DOT.

ACTION: Notice.

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SUMMARY: The Bureau of Transportation Statistics (BTS) within the
Department of Transportation (DOT) invites the general public and other
Federal agencies to comment on a proposed information collection. BTS
plans to collect information from the public to fulfill its data
security requirements when providing access to restricted use microdata
for the purpose of evidence building. BTS's data security agreements
and other paperwork along with the corresponding security protocols
allow BTS to maintain careful controls on confidentiality and privacy,
as required by law. The purpose of this notice is to allow for 60 days
of public comment on the proposed data security information collection,
prior to submission of the information collection request (ICR) to the
Office of Management and Budget (OMB).

DATES: Written comments on this notice must be received by January 17,
2023 to be assured of consideration. Comments received after that date
will be considered to the extent practicable. Send comments to the
address below.
    Comments: Comments are invited on (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of BTS, including whether the information will have
practical utility; (b) the accuracy of BTS's estimate of the burden of
the proposed collection of information; (c) ways to enhance the
quality, use, and clarity of the information on respondents, including
through the use of automated collection techniques or other forms of
information technology; and (d) ways to minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology.

FOR FURTHER INFORMATION CONTACT: Clara Reschovsky, BTS Confidentiality
Officer, BTS, OST-R, Department of Transportation, 1200 New Jersey Ave.
SE, Room E36-324, Washington, DC 20590,<PHONE_NUMBER>, Office hours
are from 8:00 a.m. to 5:30 p.m., E.T., Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION: The Foundations for Evidence-Based
Policymaking Act of 2018 mandates that the Office of Management and
Budget (OMB) establish a Standard Application Process (SAP) for
requesting access to certain confidential data assets. While the
adoption of the SAP is required for statistical agencies and units
designated under the Confidential Information Protection and
Statistical Efficiency Act (CIPSEA), it is recognized that other
agencies and organizational units within the Executive branch may
benefit from the adoption of the SAP to accept applications for access
to confidential data assets. The SAP is to be a process through which
agencies, the Congressional Budget Office, State, local, and Tribal
governments, researchers, and other individuals, as appropriate, may
apply to access confidential data assets held by a federal statistical
agency or unit for the purposes of developing evidence. With the
Interagency Council on Statistical Policy (ICSP) as advisors, the
entities upon whom this requirement is levied are working with the SAP
Project Management Office (PMO) and with OMB to implement the SAP. The
SAP Portal is to be a single web-based common application for the
public to request access to confidential data assets from federal
statistical agencies and units. The National Center for Science and
Engineering Statistics (NCSES), within the National Science Foundation
(NSF), submitted a Federal Register Notice in September 2022 announcing
plans to collect information through the SAP Portal (87 FR 53793).
    Once an application for confidential data is approved through the
SAP Portal, BTS will collect information to meet its data security
requirements. This collection will occur outside of the SAP Portal.
    Title of collection: Data Security Requirements for Accessing
Confidential Data
    OMB Control Number: DOT-OST-2022-0130
    Expiration Date of Current Approval: Not Applicable.
    Type of Request: Intent to seek approval to collect information
from the public to fulfill BTS security requirements allowing
individuals to access confidential data assets for the purposes of
building evidence.
    Abstract: Title III of the Foundations for Evidence-Based
Policymaking Act of 2018 (hereafter referred to as the Evidence Act)
mandates that OMB establish a Standard Application Process (SAP) for
requesting access to certain confidential data assets. Specifically,
the Evidence Act requires OMB to establish a common application process
through which agencies, the Congressional Budget Office, State, local,
and Tribal governments, researchers, and other individuals, as
appropriate, may apply for access to confidential data assets
collected, accessed, or acquired by a statistical agency or unit. This
new process will be implemented while maintaining stringent controls to
protect confidentiality and privacy, as required by law.
    Data collected, accessed, or acquired by statistical agencies and
units is vital for developing evidence on conditions, characteristics,
and behaviors of the public and on the operations and outcomes of
public programs and policies. This evidence can benefit the
stakeholders in the programs, the broader public, as well as
policymakers and program managers at the local, State, Tribal, and
National levels. The many benefits of access to data for evidence
building notwithstanding, BTS is required by law to maintain careful
controls that allow it to minimize disclosure risk while protecting
confidentiality and privacy. The fulfillment of BTS's data security
requirements places a degree of burden on the public, which is outlined
below.
    The SAP Portal is a web-based application for the public to request
access to confidential data assets from

federal statistical agencies and units. The objective of the SAP Portal
is to increase public access to confidential data for the purposes of
evidence building and reduce the burden of applying for confidential
data. Once an individual's application in the SAP Portal has received a
positive determination, the data-owning agency(ies) or unit(s) will
begin the process of collecting information to fulfill their data
security requirements.
    The paragraphs below outline the SAP Policy, the steps to complete
an application through the SAP Portal, and the process for agencies to
collect information fulfilling their data security requirements.

The SAP Policy

    At the recommendation of the ICSP, the SAP Policy establishes the
SAP to be implemented by statistical agencies and units and
incorporates directives from the Evidence Act. The policy is intended
to provide guidance as to the application and review processes using
the SAP Portal, setting forth clear standards that enable statistical
agencies and units to implement a common application form and a uniform
review process. The SAP Policy was submitted to the public for comment
in January 2022 (87 FR 2459). The policy is currently under review and
has not yet been finalized.

The SAP Portal

    The SAP Portal is an application interface connecting applicants
seeking data with a catalog of data assets owned by the federal
statistical agencies and units. The SAP Portal is not a new data
repository or warehouse; confidential data assets will continue to be
stored in secure data access facilities owned and hosted by the federal
statistical agencies and units. The Portal will provide a streamlined
application process across agencies, reducing redundancies in the
application process. This single SAP Portal will improve the process
for applicants, tracking and communicating the application process
throughout its lifecycle. This reduces redundancies and burden on
applicants that request access to data from multiple agencies. The SAP
Portal will automate key tasks to save resources and time and will
bring agencies into compliance with the Evidence Act statutory
requirements.

Data Discovery

    Individuals begin the process of accessing restricted use data by
discovering confidential data assets through the SAP data catalog,
maintained by federal statistical agencies at www.researchdatagov.org.
Potential applicants can search by agency, topic, or keyword to
identify data of interest or relevance. Once they have identified data
of interest, applicants can view metadata outlining the title,
description or abstract, scope and coverage, and detailed methodology
related to a specific data asset to determine its relevance to their
research.
    While statistical agencies and units shall endeavor to include
metadata in the SAP data catalog on all confidential data assets for
which they accept applications, it may not be feasible to include
metadata for some data assets (e.g., potential curated versions of
administrative data). A statistical agency or unit may still accept an
application through the SAP Portal even if the requested data asset is
not listed in the SAP data catalog.

SAP Application Process

    Individuals who have identified and wish to access confidential
data assets will be able to apply for access through the SAP Portal
when it is released to the public in late 2022. Applicants must create
an account and follow all steps to complete the application. Applicants
begin by entering their personal, contact, and institutional
information, as well as the personal, contact, and institutional
information of all individuals on their research team. Applicants
proceed to provide summary information about their proposed project, to
include project title, duration, funding, timeline, and other details
including the data asset(s) they are requesting and any proposed
linkages to data not listed in the SAP data catalog, including non-
federal data sources. Applicants then proceed to enter detailed
information regarding their proposed project, including a project
abstract, research question(s), literature review, project scope,
research methodology, project products, and anticipated output.
Applicants must demonstrate a need for confidential data, outlining why
their research question cannot be answered using publicly available
information.

Submission for Review

    Upon submission of their application, applicants will receive a
notification that their application has been received and is under
review by the data owning agency or agencies (in the event where data
assets are requested from multiple agencies). At this point, applicants
will also be notified that application approval does not alone grant
access to confidential data, and that, if approved, applicants must
comply with the data-owning agency's security requirements outside of
the SAP Portal, which may include a background check.
    In accordance with the Evidence Act and the direction of the ICSP,
agencies will approve or reject an application within a prompt
timeframe. In some cases, agencies may determine that additional
clarity, information, or modification is needed and request the
applicant to ``revise and resubmit'' their application.
    Data discovery, the SAP application process, and the submission for
review are planned to take place within the web-based SAP Portal. As
noted above, the notice announcing plans to collect information through
the SAP Portal has been published separately (87 FR 53793).

Access to Restricted Use Data

    In the event of a positive determination, the applicant will be
notified that their proposal has been accepted. The positive or final
adverse determination concludes the SAP Portal process. In the instance
of a positive determination, the data-owning agency (or agencies) will
contact the applicant to provide instructions on the agency's security
requirements that must be completed to gain access to the confidential
data. The completion and submission of the agency's security
requirements will take place outside of the SAP Portal.

Collection of Information for Data Security Requirements

    In the instance of a positive determination for an application
requesting access to a BTS confidential data asset, BTS will contact
the applicant(s) to initiate the process of collecting information to
fulfill their security requirements. These include additional
requirements necessary for the statistical agency or unit to place the
applicant(s) in a trusted category that may include the applicant's
successful completion of a background investigation, confidentiality
training, nondisclosure, and data use agreements.
    Estimate of Burden: The amount of time to complete the agreements
and other paperwork that comprise BTS's security requirements will vary
based on the confidential data assets requested and the access
modality. To obtain access to BTS confidential data assets, it is
estimated that the average time to complete and submit BTS's data
security agreements and other paperwork is 90 minutes. This estimate
does not include the time needed to complete and submit an application
within the SAP Portal. All efforts related to SAP Portal applications
occur prior to and separate from BTS's effort to collect

information related to data security requirements.
    The expected number of applications in the SAP Portal that receive
a positive determination from BTS in a given year may vary. Overall,
per year, BTS estimates it will collect data security information for
five application submissions that received a positive determination
within the SAP Portal. BTS estimates that the total burden for the
collection of information for data security requirements over the
course of the three-year OMB clearance will be about 22.5 hours and, as
a result, an average annual burden of 7.5 hours.

    Issued in Washington, DC on the 10th of November 2022.
Cha-Chi Fan,
Director, Office of Data Development and Standards, Bureau of
Transportation Statistics, Office of the Assistant Secretary for
Research and Technology.
[FR Doc. 2022-24899 Filed 11-15-22; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: September 26, 2006 (Volume 71, Number 186)]
[Notices]
[Page 56141]
[DOCID:fr26se06-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP06-335-001]

Maritimes & Northeast Pipeline, L.L.C.; Notice of Amendment to
Application for Certificate of Public Convenience and Necessity

September 19, 2006.
    Take notice that on September 11, 2006, Maritimes & Northeast
Pipeline, L.L.C. (Maritimes), 890 Winter Street, Suite 300, Waltham,
Massachusetts 02451, filed in Docket No. CP06-335-001, an amendment to
its application filed on May 16, 2006 pursuant to section 7 of the
Natural Gas Act (NGA) for authorization for its Phase IV Project. In
the instant amended application, Maritimes states that the only change
to the project originally proposed in the May 16, 2006 application is
to remove the facilities proposed to accommodate 150,000 Dth/day of
capacity for Portland Natural Gas Transmission System (PNGTS) on the
mainline facilities jointly owned by Maritimes and PNGTS that extend
from Westbrook, Maine to Dracut, Massachusetts, all as more fully set
forth in the application which is on file with the Commission and open
to public inspection. More specifically, Maritimes states that the only
change to the originally proposed facilities is to install a smaller
compressor unit at the proposed Eliot Compressor Station in York
County, Maine. This filing may be also viewed on the Web at http://www.ferc.gov
 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
the document. For assistance, call<PHONE_NUMBER> or TTY, (202) 502-
8659.
    Maritimes requests a shortened notice procedure for this filing.
Maritimes states that the shortened notice procedure is appropriate
because the proposed modification to the original project is minor and
the impact associated with the modification on existing customers and
affected landowners and communities is minimal.
    Any questions concerning this application may be directed to Steven
E. Tillman, General Manager, Regulatory Affairs, M&N Management
Company, 5400 Westheimer Court, P.O. Box 1642, Houston, Texas 77251-
1642.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, before the
comment date of this notice, file with the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426, a motion to
intervene in accordance with the requirements of the Commission's Rules
of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the NGA (18 CFR 157.10). A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the
proceeding can ask for court review of Commission orders in the
proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.
    Comment Date: 5 p.m. Eastern Time on September 29, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-15680 Filed 9-25-06; 8:45 am]

BILLING CODE 6717-01-P