82 FR 13551 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 48 (March 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 48 (March 14, 2017)
| Page Range | 13551-13553 | |
| FR Document | 2017-04941 |
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)] [Rules and Regulations] [Pages 13551-13553] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04941] [[Page 13551]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2017-N-1142] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the high throughput genomic sequence analyzer for clinical use 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 classification of the high throughput genomic sequence analyzer for clinical use device. 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 March 14, 2017. The classification was applicable on November 19, 2013. FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD, 20993-0002, 301-796-5866, [email protected]. 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) of the FD&C Act, 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. Section 513(f)(2) of the FD&C Act, also known as De Novo classification, 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) of the FD&C Act, the person requests a classification under section 513(f)(2). 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on September 13, 2013, classifying the Illumina MiSeqDx Platform 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 September 23, 2013, FDA received from Illumina, Inc., a request for classification of the Illumina MiSeqDx Platform submitted under section 513(f)(2) of the FD&C Act. 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 November 19, 2013, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 862.2265. Following the effective date of this final classification order, any firm intending to market a high throughput genomic sequence analyzer for clinical use will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or PMA in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome pathway of 510(k), when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers. The device is assigned the generic name high throughput genomic sequence analyzer for clinical use, and it is identified as an analytical instrument system intended to generate, measure and sort signals in order to analyze nucleic acid sequences in a clinical sample. The device may include a signal reader unit; reagent handling, dedicated instrument control, and other hardware components; raw data storage mechanisms; data acquisition software; and software to process detected signals. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks: [[Page 13552]] Table 1--High Throughput Genomic Sequence Analyzer for Clinical Use Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks to health Required mitigations ------------------------------------------------------------------------ Inaccurate test results due to Special Control (1) (21 CFR unavailability of necessary components of 862.2265(b)(1)). the instrument system. Inaccurate results due to unknown Special Control (2) (21 CFR performance of the instrument system. 862.2265(b)(2)). ------------------------------------------------------------------------ FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. The special controls for a high throughput genomic sequence analyzer for clinical use include a detailed outline of analytical performance information that must be generated for the instrument system (i.e., platform and all associated software). This includes analytical validation using well characterized samples (i.e., well characterized or reference materials) to demonstrate the system's capabilities and to identify limitations. The validation testing, as required by the special controls, only establishes the instrument's general capabilities and does not establish the instrument's capabilities or suitability with respect to any specific claims. Instruments indicated for a specific diagnostic test, including those that make claims for a specific test, (e.g., hematology panel; oncology panel) require additional independent validation and are not high throughput genomic sequence analyzers for clinical use under 21 CFR 862.2265. 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), 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 believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements under section 510(m) of the FD&C Act. Once finalized, persons who intend to market this device type need not submit a 510(k) premarket notification containing information on the high throughput genomic sequence analyzer for clinical use prior to marketing the device. II. Analysis of Environmental Impact We have 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 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 parts 801 and 809, regarding labeling have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 862 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 862 is amended as follows: PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 0 1. The authority citation for part 862 is revised to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 862.2265 to subpart C to read as follows: Sec. 862.2265 High throughput genomic sequence analyzer for clinical use. (a) Identification. A high throughput genomic sequence analyzer for clinical use is an analytical instrument system intended to generate, measure and sort signals in order to analyze nucleic acid sequences in a clinical sample. The device may include a signal reader unit; reagent handling, dedicated instrument control, and other hardware components; raw data storage mechanisms; data acquisition software; and software to process detected signals. (b) Classification. Class II (special controls). The special controls for this device are: (1) The labeling for the instrument system must reference legally marketed pre-analytical and analytical reagents to be used with the instrument system and include or reference legally marketed analytical software that includes sequence alignment and variant calling functions, to be used with the instrument system. (2) The labeling for the instrument system must include a description of the following information: (i) The specimen type(s) validated as an appropriate source of nucleic acid for this instrument. (ii) The type(s) of nucleic acids (e.g., germline DNA, tumor DNA) validated with this instrument. (iii) The type(s) of sequence variations (e.g. single nucleotide variants, insertions, deletions) validated with this instrument. (iv) The type(s) of sequencing (e.g., targeted sequencing) validated with this instrument. (v) The appropriate read depth for the sensitivity claimed and validation information supporting those claims. (vi) The nucleic acid extraction method(s) validated for use with the instrument system. (vii) Limitations must specify the types of sequence variations that the instrument cannot detect with the claimed accuracy and precision (e.g., insertions or deletions larger than a certain size, translocations). (viii) Performance characteristics of the instrument system must include: (A) Reproducibility data generated using multiple instruments and multiple operators, and at multiple sites. Samples tested must include all claimed specimen types, nucleic acid types, sequence variation types, and types of sequencing. Variants queried shall be located in varying sequence context (e.g., different chromosomes, GC-rich regions). Device results shall be compared to reference sequence data with high confidence. (B) Accuracy data for all claimed specimen types and nucleic acid types generated by testing a panel of well characterized samples to query all claimed sequence variation types, types of sequencing, and sequences located in varying sequence context (e.g., different chromosomes, GC-rich regions). The well-characterized sample panel shall include samples from at least two sources that have highly confident sequence based on well-validated sequencing methods. At least one [[Page 13553]] reference source shall have sequence generated independently of the manufacturer with respect to technology and analysis. Percent agreement and percent disagreement with the reference sequences must be described for all regions queried by the instrument. (C) If applicable, data describing endogenous or exogenous substances that may interfere with the instrument system. (D) If applicable, data demonstrating the ability of the system to consistently generate an accurate result for a given sample across different indexing primer combinations. (ix) The upper and lower limit of input nucleic acid that will achieve the claimed accuracy and reproducibility. Data supporting such claims must also be summarized. Dated: March 8, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-04941 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Rules and Regulations 13551
DEPARTMENT OF HEALTH AND means of premarket notification with section 513(f)(2) of the FD&C Act,
HUMAN SERVICES procedures in section 510(k) of the FDA reviewed the request in order to
FD&C Act (21 U.S.C. 360(k)) and part classify the device under the criteria for
Food and Drug Administration 807 (21 CFR part 807) of the regulations. classification set forth in section
Section 513(f)(2) of the FD&C Act, 513(a)(1) of the FD&C Act. FDA
21 CFR Part 862 also known as De Novo classification, as classifies devices into class II if general
[Docket No. FDA–2017–N–1142]
amended by section 607 of the Food and controls by themselves are insufficient
Drug Administration Safety and to provide reasonable assurance of
Medical Devices; Clinical Chemistry Innovation Act (Pub. L. 112–144), safety and effectiveness, but there is
and Clinical Toxicology Devices; provides two procedures by which a sufficient information to establish
Classification of the High Throughput person may request FDA to classify a special controls to provide reasonable
Genomic Sequence Analyzer for device under the criteria set forth in assurance of the safety and effectiveness
Clinical Use section 513(a)(1) of the FD&C Act. of the device for its intended use. After
Under the first procedure, the person review of the information submitted in
AGENCY: Food and Drug Administration, submits a premarket notification under
HHS. the request, FDA determined that the
section 510(k) of the FD&C Act for a device can be classified into class II
ACTION: Final order. device that has not previously been with the establishment of special
classified and, within 30 days of controls. FDA believes these special
SUMMARY: The Food and Drug
receiving an order classifying the device controls, in addition to general controls,
Administration (FDA) is classifying the
into class III under section 513(f)(1) of will provide reasonable assurance of the
high throughput genomic sequence the FD&C Act, the person requests a
analyzer for clinical use into class II safety and effectiveness of the device.
classification under section 513(f)(2).
(special controls). The special controls Under the second procedure, rather than Therefore, on November 19, 2013,
that will apply to the device are first submitting a premarket notification FDA issued an order to the requestor
identified in this order and will be part under section 510(k) of the FD&C Act classifying the device into class II. FDA
of the codified language for the and then a request for classification is codifying the classification of the
classification of the high throughput under the first procedure, the person device by adding 21 CFR 862.2265.
genomic sequence analyzer for clinical determines that there is no legally Following the effective date of this
use device. The Agency is classifying marketed device upon which to base a final classification order, any firm
the device into class II (special controls) determination of substantial intending to market a high throughput
in order to provide a reasonable equivalence and requests a classification genomic sequence analyzer for clinical
assurance of safety and effectiveness of under section 513(f)(2) of the FD&C Act. use will need to comply with the special
the device. If the person submits a request to controls named in this final order. A De
DATES: This order is effective March 14, classify the device under this second Novo classification decreases regulatory
2017. The classification was applicable procedure, FDA may decline to burdens. When FDA classifies a device
on November 19, 2013. undertake the classification request if type as class I or II via the De Novo
FOR FURTHER INFORMATION CONTACT: FDA identifies a legally marketed device pathway, other manufacturers do not
Steven Tjoe, Center for Devices and that could provide a reasonable basis for have to submit a De Novo request or
Radiological Health, Food and Drug review of substantial equivalence with PMA in order to market the same type
Administration, 10903 New Hampshire the device or if FDA determines that the of device, unless the device has a new
Ave., Bldg. 66, Rm. 4550, Silver Spring, device submitted is not of ‘‘low- intended use or technological
MD, 20993–0002, 301–796–5866, moderate risk’’ or that general controls characteristics that raise different
steven.tjoe@fda.hhs.gov. would be inadequate to control the risks questions of safety or effectiveness.
SUPPLEMENTARY INFORMATION: and special controls to mitigate the risks Instead, manufacturers can use the less
cannot be developed. burdensome pathway of 510(k), when
I. Background In response to a request to classify a necessary, to market their device, and
In accordance with section 513(f)(1) of device under either procedure provided the device that was the subject of the
the Federal Food, Drug, and Cosmetic by section 513(f)(2) of the FD&C Act, original De Novo classification can serve
Act (the FD&C Act) (21 U.S.C. FDA shall classify the device by written as a predicate device for additional
360c(f)(1)), devices that were not in order within 120 days. This 510(k)s from other manufacturers.
commercial distribution before May 28, classification will be the initial
1976 (the date of enactment of the classification of the device. In The device is assigned the generic
Medical Device Amendments of 1976), accordance with section 513(f)(1) of the name high throughput genomic
generally referred to as postamendments FD&C Act, FDA issued an order on sequence analyzer for clinical use, and
devices, are classified automatically by September 13, 2013, classifying the it is identified as an analytical
statute into class III without any FDA Illumina MiSeqDx Platform into class instrument system intended to generate,
rulemaking process. These devices III, because it was not substantially measure and sort signals in order to
remain in class III and require equivalent to a device that was analyze nucleic acid sequences in a
premarket approval unless and until the introduced or delivered for introduction clinical sample. The device may include
device is classified or reclassified into into interstate commerce for commercial a signal reader unit; reagent handling,
class I or II, or FDA issues an order distribution before May 28, 1976, or a dedicated instrument control, and other
finding the device to be substantially device which was subsequently hardware components; raw data storage
mechanisms; data acquisition software;
rmajette on DSK30RV082PROD with RULES
equivalent, in accordance with section reclassified into class I or class II.
513(i) of the FD&C Act, to a predicate On September 23, 2013, FDA received and software to process detected signals.
device that does not require premarket from Illumina, Inc., a request for FDA has identified the following risks
approval. The Agency determines classification of the Illumina MiSeqDx to health associated specifically with
whether new devices are substantially Platform submitted under section this type of device and the measures
equivalent to predicate devices by 513(f)(2) of the FD&C Act. In accordance required to mitigate these risks:
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![Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Rules and Regulations 13553
reference source shall have sequence I. Background In response to a request to classify a
generated independently of the In accordance with section 513(f)(1) of device under either procedure provided
manufacturer with respect to technology the Federal Food, Drug, and Cosmetic by section 513(f)(2) of the FD&C Act,
and analysis. Percent agreement and Act (the FD&C Act) (21 U.S.C. FDA shall classify the device by written
percent disagreement with the reference 360c(f)(1)), devices that were not in order within 120 days. This
sequences must be described for all commercial distribution before May 28, classification will be the initial
regions queried by the instrument. 1976 (the date of enactment of the classification of the device. In
(C) If applicable, data describing Medical Device Amendments of 1976), accordance with section 513(f)(1) of the
endogenous or exogenous substances generally referred to as postamendments FD&C Act, FDA issued an order on June
that may interfere with the instrument devices, are classified automatically by 14, 2011, classifying the Symphony
system. statute into class III without any FDA Device into class III, because it was not
(D) If applicable, data demonstrating rulemaking process. These devices substantially equivalent to a device that
the ability of the system to consistently remain in class III and require was introduced or delivered for
generate an accurate result for a given premarket approval unless and until the introduction into interstate commerce
sample across different indexing primer device is classified or reclassified into for commercial distribution before May
combinations. class I or II, or FDA issues an order 28, 1976, or a device which was
(ix) The upper and lower limit of subsequently reclassified into class I or
finding the device to be substantially
input nucleic acid that will achieve the class II.
equivalent, in accordance with section
claimed accuracy and reproducibility. On July 13, 2011, Sensory Medical,
513(i) of the FD&C Act, to a predicate
Data supporting such claims must also Inc. submitted a request for
device that does not require premarket classification of the Symphony Device
be summarized.
approval. The Agency determines under section 513(f)(2) of the FD&C Act.
Dated: March 8, 2017. whether new devices are substantially In accordance with section 513(f)(2) of
Leslie Kux, equivalent to predicate devices by the FD&C Act, FDA reviewed the
Associate Commissioner for Policy. means of premarket notification request in order to classify the device
[FR Doc. 2017–04941 Filed 3–13–17; 8:45 am] procedures in section 510(k) of the under the criteria for classification set
BILLING CODE 4164–01–P FD&C Act (21 U.S.C. 360(k)) and part forth in section 513(a)(1). FDA classifies
807 (21 CFR part 807) of the regulations. devices into class II if general controls
Section 513(f)(2) of the FD&C Act, by themselves are insufficient to
DEPARTMENT OF HEALTH AND also known as De Novo classification, as provide reasonable assurance of safety
HUMAN SERVICES amended by section 607 of the Food and and effectiveness, but there is sufficient
Drug Administration Safety and information to establish special controls
Food and Drug Administration Innovation Act (Pub. L. 112–144), to provide reasonable assurance of the
provides two procedures by which a safety and effectiveness of the device for
21 CFR Part 882 person may request FDA to classify a its intended use. After review of the
[Docket No. FDA–2017–N–1123] device under the criteria set forth in information submitted in the request,
section 513(a)(1). Under the first FDA determined that the device can be
Medical Devices; Neurological procedure, the person submits a classified into class II with the
Devices, Classification of the Vibratory premarket notification under section establishment of special controls. FDA
Counter-Stimulation Device 510(k) of the FD&C Act for a device that believes these special controls, in
has not previously been classified and, addition to general controls, will
AGENCY: Food and Drug Administration, within 30 days of receiving an order provide reasonable assurance of the
HHS. classifying the device into class III safety and effectiveness of the device.
ACTION: Final order. under section 513(f)(1) of the FD&C Act, Therefore, on December 18, 2013,
the person requests a classification FDA issued an order to the requestor
SUMMARY: The Food and Drug under section 513(f)(2). Under the
Administration (FDA) is classifying the classifying the device into class II. FDA
second procedure, rather than first is codifying the classification of the
vibratory counter-stimulation device submitting a premarket notification
into class II (special controls). The device by adding 21 CFR 882.5895.
under section 510(k) of the FD&C Act Following the effective date of this
special controls that will apply to the and then a request for classification final classification order, any firm
device are identified in this order and under the first procedure, the person submitting a premarket notification
will be part of the codified language for determines that there is no legally (510(k)) for a vibratory counter-
the vibratory counter-stimulation marketed device upon which to base a stimulation device will need to comply
device’s classification. The Agency is determination of substantial with the special controls named in this
classifying the device into class II equivalence and requests a classification final order. A De Novo classification
(special controls) in order to provide a under section 513(f)(2) of the FD&C Act. decreases regulatory burdens. When
reasonable assurance of safety and If the person submits a request to FDA classifies a device type as class I
effectiveness of the device. classify the device under this second or II via the De Novo pathway, other
DATES: This order is effective March 14, procedure, FDA may decline to manufacturers do not have to submit a
2017. The classification was applicable undertake the classification request if De Novo request or PMA in order to
on December 18, 2013. FDA identifies a legally marketed device market the same type of device, unless
FOR FURTHER INFORMATION CONTACT: that could provide a reasonable basis for the device has a new intended use or
Michael Hoffmann, Center for Devices review of substantial equivalence with technological characteristics that raise
rmajette on DSK30RV082PROD with RULES
and Radiological Health, Food and Drug the device or if FDA determines that the different questions of safety or
Administration, 10903 New Hampshire device submitted is not of ‘‘low- effectiveness. Instead, manufacturers
Ave., Bldg. 66, Rm. 2640, Silver Spring, moderate risk’’ or that general controls can use the less burdensome pathway of
MD 20993–0002, 301–796–6476, would be inadequate to control the risks 510(k), when necessary, to market their
michael.hoffmann@fda.hhs.gov. and special controls to mitigate the risks device, and the device that was the
SUPPLEMENTARY INFORMATION: cannot be developed. subject of the original De Novo
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Document Created: 2017-03-14 02:51:33
Document Modified: 2017-03-14 02:51:33
| 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 March 14, 2017. The classification was applicable on November 19, 2013. | |
| Contact | Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD, 20993-0002, 301-796-5866, [email protected] | |
| FR Citation | 82 FR 13551 |
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