81_FR_45004 81 FR 44872 - Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices; Public Workshop

81 FR 44872 - Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 132 (July 11, 2016)

Page Range44872-44873
FR Document2016-16353

The Food and Drug Administration (FDA), in cosponsorship with the American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Association for Pediatric Ophthalmology and Strabismus (AAPOS), American Optometric Association (AOA), American Society of Cataract and Refractive Surgery (ASCRS), and Contact Lens Association of Ophthalmologists, Inc. (CLAO) is announcing a public workshop entitled ``Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices.'' The purpose of this workshop is to discuss the increasing prevalence of myopia, as well as suggested clinical trial design attributes for studies using contact lenses or other medical devices to control the progression of myopia.

Federal Register, Volume 81 Issue 132 (Monday, July 11, 2016)
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44872-44873]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Controlling the Progression of Myopia: Contact Lenses and Future 
Medical Devices; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with 
the American Academy of Ophthalmology (AAO), American Academy of 
Optometry (AAOpt), American Association for Pediatric Ophthalmology and 
Strabismus (AAPOS), American Optometric Association (AOA), American 
Society of Cataract and Refractive Surgery (ASCRS), and Contact Lens 
Association of Ophthalmologists, Inc. (CLAO) is announcing a public 
workshop entitled ``Controlling the Progression of Myopia: Contact 
Lenses and Future Medical Devices.'' The purpose of this workshop is to 
discuss the increasing prevalence of myopia, as well as suggested 
clinical trial design attributes for studies using contact lenses or 
other medical devices to control the progression of myopia.

DATES: The public workshop will be held on September 30, 2016, from 8 
a.m. to 6 p.m. Pickup of materials will begin at 7:30 a.m.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the 
Great Room, (Rm. 1503), Silver Spring, MD, 20993. Entrance for the 
public workshop participants (non-FDA employees) is through Building 1 
where routine security check procedures will be performed. For parking 
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Michelle Tarver, Office of Device 
Evaluation, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2504, Silver 
Spring, MD 20993, 301-796-6884.

SUPPLEMENTARY INFORMATION: 

I. Background

    The prevalence of myopia in the United States has increased over 
the past decade with approximately 24 percent (over 30 million) of 
adults over 40 years of age being affected. Recent studies have found 
the overall prevalence of myopia to be 1.2 percent among non-Hispanic 
White children, 6.6 percent in African Americans, 3.7 percent in 
Hispanic, and 3.98 percent in Asian children. Pathologic myopia is the 
third most frequent cause of blindness due to retinal detachments or 
abnormal blood vessel growth. Given these potentially poor outcomes 
with high myopia, researchers have sought ways to prevent its 
development by starting interventions in childhood. The literature 
suggests that myopia progression is most rapid between 6 and 11 years 
of age and manipulating peripheral retinal image quality may be a 
treatment strategy to control axial length and therefore the 
progression of myopia. The results of studies conducted with 
specialized contact lenses, both rigid and soft, have indicated that 
this approach may reduce the rate of myopic progression in children. As 
research into myopia control is continuing at a rapid pace, 
accompanying potential safety and effectiveness questions also have 
emerged. To ensure that the studies conducted provide information that 
can adequately inform the regulatory review, we are conducting a 
workshop to answer questions about the appropriate clinical trial 
design and outcomes for these devices.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not 
limited to the following topics:
     Myopia Demographics.
     Contact Lens Use and Safety in a Pediatric Population.
     Contact Lens Behaviors and Hygiene.
     Studies Conducted on Myopia Control Devices and Their 
Challenges.
     Regulation of Contact Lenses (Ref. 1).
     Patient/Caregiver Perspectives and the Role in Trial 
Design and Conduct (Refs. 2 and 3).
    We will also have a panel discussion to address questions related 
to the design of these clinical trials.

[[Page 44873]]

    Registration: Registration is $250 for members of AAO, AAOpt, 
AAPOS, AOA, ASCRS, or CLAO; and $400 for non-members and available on a 
first-come, first-served basis. Persons interested in attending this 
public workshop must register online. The deadline for online 
registration is September 23, 2016, at 4 p.m. EDT. There will be no 
onsite registration on the day of the public workshop. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization.
    If you need special accommodations due to a disability, please 
contact Ms. Susan Monahan at susan.monahan@fda.hhs.gov or 301-796-5661 
no later than September 16, 2016.
    To register for the public workshop, please visit http://www.cfom.info/meetings/myopia/. Please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, telephone number, and membership in the cosponsoring 
organizations. If there are any questions with registration, please 
contact Mrs. Bobbi Hahn at bhahn@cfom.info. Registrants will receive 
confirmation after they have been accepted. You will be notified if you 
are on a waiting list.
    Food may be purchased in advance for $45 on the registration Web 
site (http://www.cfom.info/meetings/myopia/). Food and beverages will 
also be available for purchase by participants during the workshop 
breaks.
    For more information on the workshop, please see the FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list.) Those 
without Internet access should contact Bobbi Hahn to register at 651-
731-7257.
    Streaming Webcast of the Public Workshop: The public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by September 23, 2016. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after September 23, 2016. If you have never attended 
a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this 
document, as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management, Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov. A link to the transcript will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

III. References

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

1. Premarket Notification [510(k)] Guidance Document for Class II 
Daily Wear Contact Lenses. U.S. Department of Health and Human 
Services, Food and Drug Administration. May 1994. http://www.fda.gov/RegulatoryInformation/Guidances/ucm080928.htm.
2. Guidance for Industry: Patient-Reported Outcome Measures: Use in 
Medical Product Development to Support Labeling Claims. U.S. 
Department of Health and Human Services, Food and Drug 
Administration. December 2009. http://www.fda.gov/downloads/Drugs/.../Guidances/UCM193282.pdf.
3. Draft Guidance: Patient Preference Information--Submission, 
Review in PMAs, HDE Applications, and De Novo Requests, and 
Inclusion in Device Labeling. U.S. Department of Health and Human 
Services, Food and Drug Administration. Posted March 2015. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446680.pdf.

    Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16353 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                44872                                    Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices

                                                   4 The reporting requirements under §§ 601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c),
                                                640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under § 601.12(b).
                                                   5 The reporting requirements under §§ 601.12(a)(2), 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under
                                                § 601.12(c).
                                                   6 The reporting requirement under § 601.12(a)(2) is included in the estimate under § 601.12(d).
                                                   7 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (2).
                                                   8 The reporting requirement under §§ 601.12(a)(4) and 601.14 is included in the estimate under § 601.12(f)(3).
                                                   9 The reporting requirement under § 601.94 is included in the estimate under § 601.45.
                                                   10 The numbers in this column have been rounded to the nearest whole number.




                                                  Under table 2, the estimated                                      recordkeeping requirements associated
                                                recordkeeping burden of 1 hour is based                             with the AER system.
                                                on previous estimates for the

                                                                                              TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
                                                                                                                                       Annual
                                                                                                                Number of            disclosures        Total annual                 Average burden
                                                                  21 CFR section                                                                                                                                      Total hours 2
                                                                                                               respondents               per            disclosures                   per disclosure
                                                                                                                                     respondent

                                                601.6(a) ..................................................         1                    20                    20        0.33 (20 minutes) ........................        7
                                                   1 There    are no capital costs or operating and maintenance costs associated with this collection of information.
                                                   2 Rounded     to the nearest whole number.


                                                  Dated: July 5, 2016.                                              to 6 p.m. Pickup of materials will begin                 starting interventions in childhood. The
                                                Leslie Kux,                                                         at 7:30 a.m.                                             literature suggests that myopia
                                                Associate Commissioner for Policy.                                  ADDRESSES: The public workshop will                      progression is most rapid between 6 and
                                                [FR Doc. 2016–16352 Filed 7–8–16; 8:45 am]                          be held at the FDA White Oak Campus,                     11 years of age and manipulating
                                                BILLING CODE 4164–01–P                                              10903 New Hampshire Ave., Bldg. 31,                      peripheral retinal image quality may be
                                                                                                                    Conference Center, the Great Room,                       a treatment strategy to control axial
                                                                                                                    (Rm. 1503), Silver Spring, MD, 20993.                    length and therefore the progression of
                                                DEPARTMENT OF HEALTH AND                                            Entrance for the public workshop                         myopia. The results of studies
                                                HUMAN SERVICES                                                      participants (non-FDA employees) is                      conducted with specialized contact
                                                                                                                    through Building 1 where routine                         lenses, both rigid and soft, have
                                                Food and Drug Administration                                        security check procedures will be                        indicated that this approach may reduce
                                                                                                                    performed. For parking and security                      the rate of myopic progression in
                                                [Docket No. FDA–2016–N–0001]                                        information, please refer to http://                     children. As research into myopia
                                                                                                                    www.fda.gov/AboutFDA/                                    control is continuing at a rapid pace,
                                                Controlling the Progression of Myopia:                                                                                       accompanying potential safety and
                                                                                                                    WorkingatFDA/BuildingsandFacilities/
                                                Contact Lenses and Future Medical                                                                                            effectiveness questions also have
                                                                                                                    WhiteOakCampusInformation/
                                                Devices; Public Workshop                                                                                                     emerged. To ensure that the studies
                                                                                                                    ucm241740.htm.
                                                AGENCY:       Food and Drug Administration,                         FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                             conducted provide information that can
                                                HHS.                                                                Michelle Tarver, Office of Device                        adequately inform the regulatory
                                                ACTION:      Notice of public workshop.                             Evaluation, Center for Devices and                       review, we are conducting a workshop
                                                                                                                    Radiological Health, Food and Drug                       to answer questions about the
                                                SUMMARY:   The Food and Drug                                        Administration, 10903 New Hampshire                      appropriate clinical trial design and
                                                Administration (FDA), in cosponsorship                              Ave., Bldg. 66, Rm. 2504, Silver Spring,                 outcomes for these devices.
                                                with the American Academy of                                        MD 20993, 301–796–6884.                                  II. Topics for Discussion at the Public
                                                Ophthalmology (AAO), American                                       SUPPLEMENTARY INFORMATION:                               Workshop
                                                Academy of Optometry (AAOpt),
                                                American Association for Pediatric                                  I. Background                                              Topics to be discussed at the public
                                                Ophthalmology and Strabismus                                           The prevalence of myopia in the                       workshop include, but are not limited to
                                                (AAPOS), American Optometric                                        United States has increased over the                     the following topics:
                                                Association (AOA), American Society of                              past decade with approximately 24                          • Myopia Demographics.
                                                Cataract and Refractive Surgery                                     percent (over 30 million) of adults over                   • Contact Lens Use and Safety in a
                                                (ASCRS), and Contact Lens Association                               40 years of age being affected. Recent                   Pediatric Population.
                                                of Ophthalmologists, Inc. (CLAO) is                                 studies have found the overall                             • Contact Lens Behaviors and
                                                announcing a public workshop entitled                               prevalence of myopia to be 1.2 percent                   Hygiene.
                                                ‘‘Controlling the Progression of Myopia:                            among non-Hispanic White children,                         • Studies Conducted on Myopia
                                                Contact Lenses and Future Medical                                   6.6 percent in African Americans, 3.7                    Control Devices and Their Challenges.
                                                Devices.’’ The purpose of this workshop                             percent in Hispanic, and 3.98 percent in                   • Regulation of Contact Lenses
sradovich on DSK3GDR082PROD with NOTICES




                                                is to discuss the increasing prevalence                             Asian children. Pathologic myopia is                     (Ref. 1).
                                                of myopia, as well as suggested clinical                            the third most frequent cause of                           • Patient/Caregiver Perspectives and
                                                trial design attributes for studies using                           blindness due to retinal detachments or                  the Role in Trial Design and Conduct
                                                contact lenses or other medical devices                             abnormal blood vessel growth. Given                      (Refs. 2 and 3).
                                                to control the progression of myopia.                               these potentially poor outcomes with                       We will also have a panel discussion
                                                DATES: The public workshop will be                                  high myopia, researchers have sought                     to address questions related to the
                                                held on September 30, 2016, from 8 a.m.                             ways to prevent its development by                       design of these clinical trials.


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                                                                                Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices                                                  44873

                                                   Registration: Registration is $250 for                get a quick overview of the Connect Pro                 Dated: July 6, 2016.
                                                members of AAO, AAOpt, AAPOS,                            program, visit http://www.adobe.com/                  Leslie Kux,
                                                AOA, ASCRS, or CLAO; and $400 for                        go/connectpro_overview. FDA has                       Associate Commissioner for Policy.
                                                non-members and available on a first-                    verified the Web site addresses in this               [FR Doc. 2016–16353 Filed 7–8–16; 8:45 am]
                                                come, first-served basis. Persons                        document, as of the date this document                BILLING CODE 4164–01–P
                                                interested in attending this public                      publishes in the Federal Register, but
                                                workshop must register online. The                       Web sites are subject to change over
                                                deadline for online registration is                      time.                                                 DEPARTMENT OF HEALTH AND
                                                September 23, 2016, at 4 p.m. EDT.                          Transcripts: Please be advised that as             HUMAN SERVICES
                                                There will be no onsite registration on                  soon as a transcript is available, it will
                                                the day of the public workshop. Early                                                                          Food and Drug Administration
                                                                                                         be accessible at http://
                                                registration is recommended because                      www.regulations.gov. It may be viewed                 [Docket No. FDA–2015–D–3787]
                                                facilities are limited and, therefore, FDA               at the Division of Dockets Management,
                                                may limit the number of participants                     Food and Drug Administration, 5630                    Information To Support a Claim of
                                                from each organization.                                                                                        Electromagnetic Compatibility of
                                                                                                         Fishers Lane, Rm. 1061, Rockville, MD
                                                   If you need special accommodations                                                                          Electrically-Powered Medical Device;
                                                                                                         20852. A transcript will also be
                                                due to a disability, please contact Ms.                                                                        Guidance for Industry and Food and
                                                Susan Monahan at susan.monahan@                          available in either hardcopy or on CD–
                                                                                                         ROM, after submission of a Freedom of                 Drug Administration Staff; Availability
                                                fda.hhs.gov or 301–796–5661 no later
                                                than September 16, 2016.                                 Information request. The Freedom of                   AGENCY:    Food and Drug Administration,
                                                   To register for the public workshop,                  Information office address is available               HHS.
                                                please visit http://www.cfom.info/                       on the Agency’s Web site at http://                   ACTION:   Notice of availability.
                                                meetings/myopia/. Please provide                         www.fda.gov. A link to the transcript
                                                complete contact information for each                    will also be available approximately 45               SUMMARY:   The Food and Drug
                                                attendee, including name, title,                         days after the public workshop on the                 Administration (FDA or Agency) is
                                                affiliation, address, email, telephone                   Internet at http://www.fda.gov/                       announcing the availability of the
                                                number, and membership in the                            MedicalDevices/NewsEvents/                            guidance entitled ‘‘Information to
                                                cosponsoring organizations. If there are                 WorkshopsConferences/default.htm.                     Support a Claim of Electromagnetic
                                                any questions with registration, please                  (Select this public workshop from the                 Compatibility (EMC) of Electrically-
                                                contact Mrs. Bobbi Hahn at bhahn@                        posted events list).                                  Powered Medical Device.’’ This
                                                cfom.info. Registrants will receive                                                                            guidance describes the types of
                                                                                                         III. References                                       information that should be provided to
                                                confirmation after they have been
                                                accepted. You will be notified if you are                  The following references are on                     support a claim of EMC in a premarket
                                                on a waiting list.                                       display in the Division of Dockets                    submission for an electrically powered
                                                   Food may be purchased in advance                      Management (see Transcripts) and are                  medical device. Electromagnetic
                                                for $45 on the registration Web site                     available for viewing by interested                   disturbance is electronic product
                                                (http://www.cfom.info/meetings/                          persons between 9 a.m. and 4 p.m.,                    radiation that may interfere with the
                                                myopia/). Food and beverages will also                   Monday through Friday; they are also                  performance of an electrically powered
                                                be available for purchase by participants                available electronically at http://                   medical device in its intended
                                                during the workshop breaks.                              www.regulations.gov. FDA has verified                 environment (i.e., cause an
                                                   For more information on the                           the Web site addresses, as of the date                electromagnetic interference (EMI)).
                                                workshop, please see the FDA’s Medical                   this document publishes in the Federal                EMC assessment helps to ensure that a
                                                Devices News & Events—Workshops &                        Register, but Web sites are subject to                device is able to function in its intended
                                                Conferences calendar at http://                          change over time.                                     environment without introducing
                                                www.fda.gov/MedicalDevices/                                                                                    excessive electromagnetic disturbances
                                                NewsEvents/WorkshopsConferences/                         1. Premarket Notification [510(k)] Guidance           that might interfere with other devices.
                                                                                                              Document for Class II Daily Wear
                                                default.htm. (Select this public                                                                               DATES: Submit either electronic or
                                                                                                              Contact Lenses. U.S. Department of
                                                workshop from the posted events list.)                                                                         written comments on this guidance at
                                                                                                              Health and Human Services, Food and
                                                Those without Internet access should                          Drug Administration. May 1994. http://           any time. General comments on Agency
                                                contact Bobbi Hahn to register at 651–                        www.fda.gov/RegulatoryInformation/               guidance documents are welcome at any
                                                731–7257.                                                     Guidances/ucm080928.htm.                         time.
                                                   Streaming Webcast of the Public                       2. Guidance for Industry: Patient-Reported            ADDRESSES: You may submit comments
                                                Workshop: The public workshop will                            Outcome Measures: Use in Medical                 as follows:
                                                also be Webcast. Persons interested in                        Product Development to Support
                                                viewing the Webcast must register                             Labeling Claims. U.S. Department of              Electronic Submissions
                                                online by September 23, 2016. Early                           Health and Human Services, Food and                Submit electronic comments in the
                                                registration is recommended because                           Drug Administration. December 2009.              following way:
                                                Webcast connections are limited.                              http://www.fda.gov/downloads/Drugs/.../            • Federal eRulemaking Portal: http://
                                                Organizations are requested to register                       Guidances/UCM193282.pdf.                         www.regulations.gov. Follow the
                                                all participants, but to view using one                  3. Draft Guidance: Patient Preference                 instructions for submitting comments.
                                                connection per location. Webcast                              Information—Submission, Review in                Comments submitted electronically,
                                                                                                              PMAs, HDE Applications, and De Novo
                                                participants will be sent technical                                                                            including attachments, to http://
sradovich on DSK3GDR082PROD with NOTICES




                                                                                                              Requests, and Inclusion in Device
                                                system requirements after registration                        Labeling. U.S. Department of Health and
                                                                                                                                                               www.regulations.gov will be posted to
                                                and will be sent connection access                            Human Services, Food and Drug                    the docket unchanged. Because your
                                                information after September 23, 2016. If                      Administration. Posted March 2015.               comment will be made public, you are
                                                you have never attended a Connect Pro                         http://www.fda.gov/downloads/                    solely responsible for ensuring that your
                                                event before, test your connection at                         medicaldevices/                                  comment does not include any
                                                https://collaboration.fda.gov/common/                         deviceregulationandguidance/                     confidential information that you or a
                                                help/en/support/meeting_test.htm. To                          guidancedocuments/ucm446680.pdf.                 third party may not wish to be posted,


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Document Created: 2016-07-09 00:21:40
Document Modified: 2016-07-09 00:21:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop.
DatesThe public workshop will be held on September 30, 2016, from 8 a.m. to 6 p.m. Pickup of materials will begin at 7:30 a.m.
ContactMichelle Tarver, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2504, Silver Spring, MD 20993, 301-796-6884.
FR Citation81 FR 44872 

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