80 FR 10330 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 38 (February 26, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 38 (February 26, 2015)
| Page Range | 10330-10333 | |
| FR Document | 2015-03934 |
[Federal Register Volume 80, Number 38 (Thursday, February 26, 2015)] [Rules and Regulations] [Pages 10330-10333] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03934] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2014-M-1957] Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the Assisted Reproduction Embryo Image Assessment System into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the Assisted Reproduction Embryo Image Assessment System classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective February 26, 2015. The classification was applicable June 6, 2014. FOR FURTHER INFORMATION CONTACT: Michael Bailey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G120, Silver Spring, MD 20993-0002, 301-796-6530. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i), to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. [[Page 10331]] Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1) of the FD&C Act. Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1), the person requests a classification under section 513(f)(2) of the FD&C Act. Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device, or if FDA determines that the device submitted is not of ``low-moderate risk'', or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On August 3, 2012, FDA issued an order classifying the EEVA System into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On August 23, 2012, Auxogyn, Inc., submitted a de novo request for classification of the EEVA System under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class II 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 reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on June 6, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding Sec. 884.6195 (21 CFR 884.6195). Following the effective date of this final classification administrative order, any firm submitting a premarket notification (510(k)) for an Assisted Reproduction Embryo Image Assessment System will need to comply with the special controls named in the final administrative order. The device is assigned the generic name Assisted Reproduction Embryo Image Assessment System, and it is identified as a prescription device that is designed to obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing. FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks in Table 1: Table 1--Assisted Reproduction Embryo Image Assessment System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measures ------------------------------------------------------------------------ Damage or Destruction of the Embryo.... Non-Clinical Performance Testing. Software Verification, Validation & Hazard Analysis. Clinical Testing. Electromagnetic Compatibility Testing. Electrical Safety Testing. Labeling. Training. Infection (Contamination of Device, Cleaning and Disinfection Labware, and Incubator). Validation. Labeling. Training. Incorrect Embryo Development Prediction Non-Clinical Performance Testing. Software Verification, Validation & Hazard Analysis. Clinical Testing. Labeling. Training. Electromagnetic Interference/Electrical Electromagnetic Compatibility Safety Issues. Testing. Electrical Safety Testing. Labeling. Use Error.............................. Labeling. Training. ------------------------------------------------------------------------ FDA believes that the following special controls, in addition to the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness:Clinical performance testing must demonstrate a reasonable assurance of the safety and effectiveness of the device to predict embryo development. Classification performance (sensitivity and specificity) and predictive accuracy (Positive Predictive Value and Negative Predictive Value) must be [[Page 10332]] assessed at the subject and embryo levels. Software validation, verification, and hazard analysis must be provided. Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following: [cir] Total light exposure and output testing; [cir] a safety analysis must be performed based on maximum (worst- case) light exposure to embryos, which also includes the safety of the light wavelength(s) emitted by the device; [cir] simulated-use testing; [cir] Mouse Embryo Assay testing to assess whether device operation impacts growth and development of mouse embryos to the blastocyst stage; [cir] cleaning and disinfection validation of reusable components; [cir] package integrity and transit testing; [cir] hardware fail-safe validation; [cir] electrical equipment safety and electromagnetic compatibility testing; and [cir] prediction algorithm reproducibility. Labeling must include the following: [cir] A detailed summary of clinical performance testing, including any adverse events; [cir] specific instructions, warnings, precautions, and training needed for safe use of the device; [cir] appropriate electromagnetic compatibility information; [cir] validated methods and instructions for cleaning and disinfection of reusable components; and [cir] information identifying compatible cultureware and explain how they are used with the device. An Assisted Reproduction Embryo Image Assessment System is a prescription device restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device. (See 21 CFR 801.109 (Prescription devices).) Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the Assisted Reproduction Embryo Image Assessment System they intend to market. II. Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Paperwork Reduction Act of 1995 This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E regarding premarket notification submissions have been approved under OMB control number 0910-0120 and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485. IV. Reference The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. K120427: De Novo Request from Auxogyn, Inc., dated August 23, 2012. List of Subjects in 21 CFR Part 884 Medical devices, Obstetrical and Gynecological devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 884 is amended as follows: PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES 0 1. The authority citation for 21 CFR part 884 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Section 884.6195 is added to subpart G to read as follows: Sec. 884.6195 Assisted Reproduction Embryo Image Assessment System. (a) Identification. An Assisted Reproduction Embryo Image Assessment System is a prescription device that is designed to obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing. (b) Classification. Class II (special controls). The special control(s) for this device are: (1) Clinical performance testing must demonstrate a reasonable assurance of safety and effectiveness of the device to predict embryo development. Classification performance (sensitivity and specificity) and predictive accuracy (Positive Predictive Value and Negative Predictive Value) must be assessed at the subject and embryo levels. (2) Software validation, verification, and hazard analysis must be provided. (3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following: (i) Total light exposure and output testing; (ii) A safety analysis must be performed based on maximum (worst- case) light exposure to embryos, which also includes the safety of the light wavelength(s) emitted by the device; (iii) Simulated-use testing; (iv) Mouse Embryo Assay testing to assess whether device operation impacts growth and development of mouse embryos to the blastocyst stage; (v) Cleaning and disinfection validation of reusable components; (vi) Package integrity and transit testing; (vii) Hardware fail-safe validation; (viii) Electrical equipment safety and electromagnetic compatibility testing; and (ix) Prediction algorithm reproducibility. (4) Labeling must include the following: (i) A detailed summary of clinical performance testing, including any adverse events; (ii) Specific instructions, warnings, precautions, and training needed for safe use of the device (iii) Appropriate electromagnetic compatibility information; (iv) Validated methods and instructions for cleaning and disinfection of reusable components; and (v) Information identifying compatible cultureware and explain how they are used with the device. [[Page 10333]] Dated: February 20, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-03934 Filed 2-25-15; 8:45 am] BILLING CODE 4164-01-P
![10330 Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Rules and Regulations
databases. As such, these special series of airplane. It is not a rule of DEPARTMENT OF HEALTH AND
conditions address these vulnerabilities. general applicability. HUMAN SERVICES
The digital systems architecture for The substance of these special
the Boeing Model 767–2C series conditions has been subjected to the Food and Drug Administration
airplanes is composed of several notice and comment period in several
connected networks. This network prior instances, and has been derived 21 CFR Part 884
architecture is used for a diverse set of without substantive change from those [Docket No. FDA–2014–M–1957]
functions providing data connectivity previously issued. It is unlikely that
between systems, including: prior public comment would result in a Medical Devices; Obstetrical and
1. Airplane control, communication, significant change from the substance Gynecological Devices; Classification
display, monitoring and navigation contained herein. Therefore, because a of the Assisted Reproduction Embryo
systems, delay would significantly affect the Image Assessment System
2. operator business and certification of the airplane, the FAA
has determined that prior public notice AGENCY: Food and Drug Administration,
administrative support systems, HHS.
3. passenger entertainment systems, and comment are unnecessary and
impracticable, and good cause exists for ACTION: Final order.
and
4. access by systems external to the adopting these special conditions upon SUMMARY: The Food and Drug
airplane. publication in the Federal Register. Administration (FDA) is classifying the
The Model 767–2C series airplane The FAA is requesting comments to Assisted Reproduction Embryo Image
electronic-system network architecture allow interested persons to submit Assessment System into class II (special
allows connection to airplane electronic views that may not have been submitted controls). The special controls that will
systems and networks, and access from in response to the prior opportunities apply to the device are identified in this
airplane external sources (e.g., operator for comment described above. order, and will be part of the codified
networks, wireless devices, Internet List of Subjects in 14 CFR Part 25 language for the Assisted Reproduction
connectivity, service-provider satellite Embryo Image Assessment System
Aircraft, Aviation safety, Reporting
communications, electronic flight bags, classification. The Agency is classifying
and recordkeeping requirements.
etc.) to the previously isolated airplane the device into class II (special controls)
electronic assets. The authority citation for these in order to provide a reasonable
This design may result in network- special conditions is as follows: assurance of safety and effectiveness of
security vulnerabilities from intentional Authority: 49 U.S.C. 106(g), 40113, 44701, the device.
or unintentional corruption of data and 44702, 44704. DATES: This order is effective February
systems required for the safety, The Special Conditions 26, 2015. The classification was
operations, and maintenance of the applicable June 6, 2014.
airplane. The existing regulations and Accordingly, pursuant to the
FOR FURTHER INFORMATION CONTACT:
guidance material did not anticipate this authority delegated to me by the
Michael Bailey, Center for Devices and
type of system architecture, or external Administrator, the following special
Radiological Health, Food and Drug
wired and wireless electronic access to conditions are issued as part of the type-
Administration, 10903 New Hampshire
airplane electronic systems. certification basis for Boeing Model
Ave., Bldg. 66, Rm. G120, Silver Spring,
Furthermore, regulations, and current 767–2C series airplanes.
MD 20993–0002, 301–796–6530.
1. The applicant must ensure airplane
system safety-assessment policy and SUPPLEMENTARY INFORMATION:
electronic-system security protection
techniques, do not address potential
from access by unauthorized sources I. Background
security vulnerabilities, which could be
external to the airplane, including those In accordance with section 513(f)(1) of
caused by unauthorized access to
possibly caused by maintenance the Federal Food, Drug, and Cosmetic
airplane electronic systems and
activity. Act (the FD&C Act) (21 U.S.C.
networks.
2. The applicant must ensure that
Special conditions have been applied 360c(f)(1)), devices that were not in
electronic-system security threats are
on past airplane programs to require commercial distribution before May 28,
identified and assessed, and that
consideration of related security 1976 (the date of enactment of the
effective electronic-system security Medical Device Amendments of 1976),
vulnerabilities. These special conditions protection strategies are implemented to
are similar to those previously applied, generally referred to as postamendments
protect the airplane from all adverse devices, are classified automatically by
except that the scope has been adjusted impacts on safety, functionality, and
to be consistent with those features statute into class III without any FDA
continued airworthiness. rulemaking process. These devices
unique to the Model 767–2C series 3. The applicant must establish
airplane. remain in class III and require
appropriate procedures to allow the
premarket approval, unless and until
Applicability operator to ensure that continued
the device is classified or reclassified
airworthiness of the airplane is
As discussed above, these special into class I or II, or FDA issues an order
maintained, including all post type-
conditions apply to Boeing Model 767– finding the device to be substantially
certification modifications that may
2C series airplanes. Should Boeing equivalent, in accordance with section
have an impact on the approved
apply later for a change to the type 513(i), to a predicate device that does
electronic-system security safeguards.
certificate to include another model not require premarket approval. The
Issued in Renton, Washington, on February Agency determines whether new
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incorporating the same novel or unusual
design feature, the special conditions 19, 2015. devices are substantially equivalent to
would apply to that model as well. John J. Piccola, Jr., predicate devices by means of
Acting Manager, Transport Airplane premarket notification procedures in
Conclusion Directorate, Aircraft Certification Service. section 510(k) of the FD&C Act (21
This action affects only certain novel [FR Doc. 2015–03970 Filed 2–25–15; 8:45 am] U.S.C. 360(k)) and part 807 (21 CFR part
or unusual design features on one model BILLING CODE 4910–13–P 807) of the regulations.
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![Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Rules and Regulations 10333
Dated: February 20, 2015. other references to subtitles, chapters, provided in section 501(h)), and which
Leslie Kux, subchapters, and sections in this does not participate in, or intervene in,
Associate Commissioner for Policy. preamble are references to subtitles, any political campaign on behalf of (or
[FR Doc. 2015–03934 Filed 2–25–15; 8:45 am] chapters, subchapters, and sections in in opposition to) any candidate for
BILLING CODE 4164–01–P
the Code and related regulations. All public office, and (iii) more than 80
references to ‘‘fee’’ in this preamble are percent of the gross revenues of which
references to the fee imposed by section is received from government programs
9010. that target low income, elderly, or
DEPARTMENT OF THE TREASURY On November 27, 2013, the Treasury disabled populations under titles XVIII,
Department and the IRS issued the XIX, and XXI of the Social Security Act;
Internal Revenue Service
Health Insurance Providers Fee and (D) any entity that is described in
regulations as final regulations (TD section 501(c)(9) (a voluntary
26 CFR Part 57
9643). On August 12, 2014, the Treasury employees’ beneficiary association
[TD 9711] Department and the IRS issued Notice (VEBA)) and is established by an entity
2014–47, 2014–35 IRB 522, to provide (other than by an employer or
RIN 1545–BM52
further guidance for the 2014 fee year on employers) for purposes of providing
Health Insurance Providers Fee the definition of a covered entity. The health care benefits.
temporary regulations provide further Section 9010(c)(3)(A) provides a
AGENCY: Internal Revenue Service (IRS), guidance on the definition of a covered controlled group rule under which all
Treasury. entity for the 2015 fee year and persons treated as a single employer
ACTION: Final and temporary subsequent fee years. under section 52(a) or (b) or section
regulations. 414(m) or (o) are treated as a single
General Overview
covered entity. Section 9010(c)(4)
SUMMARY: This document contains Section 9010(a) imposes an annual fee provides that, if more than one person
temporary regulations that provide rules on each covered entity engaged in the is liable to pay the fee on a single
for the definition of a covered entity for business of providing health insurance. covered entity by reason of the
purposes of the fee imposed by section The fee is due by the annual date application of the controlled group rule,
9010 of the Patient Protection and specified by the Secretary, but in no then all such persons are jointly and
Affordable Care Act, as amended. The event later than September 30th of each severally liable for payment of the fee.
temporary regulations are necessary to calendar year in which a fee must be Section 57.2(c)(1) of the Health
clarify certain terms in section 9010. paid (fee year). Insurance Providers Fee regulations
The temporary regulations affect Section 9010(b) requires the Secretary defines the term controlled group to
persons engaged in the business of to determine the annual fee for each mean a group of two or more persons,
providing health insurance for United covered entity based on the ratio of the including at least one person that is a
States health risks. The text of the covered entity’s net premiums written covered entity, that is treated as a single
temporary regulations also serves as the for health insurance for any United employer under section 52(a), 52(b),
text of the proposed regulations (REG– States health risk that are taken into 414(m), or 414(o). Section 57.2(c)(3)(ii)
143416–14) published in the Proposed account for the calendar year further provides that a person is treated
Rules section in this issue of the Federal immediately before the fee year (data as being a member of the controlled
Register. year) to the aggregate net premiums group if it is a member of the group at
written for health insurance of United the end of the day on December 31st of
DATES: Effective Date: These regulations
States health risks of all covered entities the data year.
are effective on February 26, 2015. that are taken into account during the
Applicability Date: For dates of data year. In calculating the fee, the Explanation of Provisions
applicability, see §§ 57.10 and 57.10T. Secretary must determine each covered Following the publication of the final
FOR FURTHER INFORMATION CONTACT: entity’s net premiums written for United regulations in TD 9643, the Treasury
Rachel S. Smith, (202) 317–6855 (not a States health risks based on reports Department and the IRS received
toll-free number). submitted to the Secretary by the questions about how to apply the
SUPPLEMENTARY INFORMATION: covered entity and through the use of exclusions under section 9010(c)(2) to
any other source of information the general definition of a covered
Background
available to the Secretary. entity. The Treasury Department and
Section 9010 of the Patient Protection Section 9010(c)(1) defines a covered the IRS also received questions about
and Affordable Care Act (PPACA), entity as any entity that provides health whether covered entities must report
Public Law 111–148 (124 Stat. 119 insurance for any United States health information on net premiums written
(2010)), as amended by section 10905 of risk during each fee year. Section for certain members of a controlled
PPACA, and as further amended by 9010(c)(2) excludes the following group. Notice 2014–47 was
section 1406 of the Health Care and entities from being covered entities: (A) subsequently issued to resolve those
Education Reconciliation Act of 2010, Any employer to the extent that the questions for the 2014 fee year. The
Public Law 111–152 (124 Stat. 1029 employer self-insures its employees’ temporary regulations adopt the general
(2010)) (collectively, the Affordable Care health risks; (B) any governmental approach of Notice 2014–47 to resolve
Act or ACA) imposes an annual fee on entity; (C) any entity (i) that is those questions for the 2015 fee year
covered entities that provide health incorporated as a nonprofit corporation and each subsequent fee year.
insurance for United States health risks. under a State law, (ii) no part of the net
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All references in this preamble to earnings of which inures to the benefit Application of Exclusions Under
section 9010 are references to the ACA. of any private shareholder or individual, Section 9010(c)(2)
Section 9010 did not amend the Internal no substantial part of the activities of Notice 2014–47 provided that, for the
Revenue Code (Code) but contains which is carrying on propaganda, or 2014 fee year, the Treasury Department
cross-references to specified Code otherwise attempting, to influence and the IRS would not treat any entity
sections. Unless otherwise indicated, all legislation (except as otherwise as a covered entity if it would be
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Document Created: 2015-12-18 13:05:24
Document Modified: 2015-12-18 13:05:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective February 26, 2015. The classification was applicable June 6, 2014. | |
| Contact | Michael Bailey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G120, Silver Spring, MD 20993-0002, 301-796-6530. | |
| FR Citation | 80 FR 10330 | |
| CFR Associated | Medical Devices and Obstetrical and Gynecological Devices |
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