82 FR 51558 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 214 (November 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 214 (November 7, 2017)
| Page Range | 51558-51560 | |
| FR Document | 2017-24161 |
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)] [Rules and Regulations] [Pages 51558-51560] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24161] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2017-N-4394] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the total 25-hydroxyvitamin D mass spectrometry test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. DATES: This order is effective November 7, 2017. The classification was applicable on May 18, 2017. 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 Upon request, FDA has classified the total 25-hydroxyvitamin D mass spectrometry test system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ``postamendments devices'' because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively). FDA may also classify a device through ``De Novo'' classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ``substantial equivalence''). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On March 20, 2017, AB Sciex LLC submitted a request for De Novo classification of the Vitamin D 200M Assay for the Topaz System. 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. We classify 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 that, in combination with the generals controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable [[Page 51559]] assurance of the safety and effectiveness of the device. Therefore, on May 18, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 862.1840. We have named the generic type of device total 25-hydroxyvitamin D mass spectrometry test system, and it is identified as a device intended for use in clinical laboratories for the quantitative determination of total 25- hydroxyvitamin D (25-OH-D) in serum or plasma to be used in the assessment of vitamin D sufficiency. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. Table 1--Total 25-hydroxyvitamin D Mass Spectrometry Test System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measures ------------------------------------------------------------------------ Clinical action based on falsely General controls; Special elevated inaccurate Vitamin D results control (1) (21 CFR may lead to unnecessary 862.1840(b)(1)); and, Special supplementation of Vitamin D. control (2) (21 CFR 862.1840(b)(2)). Clinical action based on falsely low General controls; Special inaccurate Vitamin D results may lead control (1) (21 CFR to a delay in supplementation of 862.1840(b)(1)); and, Special Vitamin D. control (2) (21 CFR 862.1840(b)(2)). Clinical action based on General controls; and, Special uninterpretable results due to lack of control (3) (21 CFR established device specific reference 862.1840(b)(3)). range values for the representative population. Clinical action based on the General controls; and, Special misinterpretation of Vitamin D2 or control (4) (21 CFR Vitamin D3 results as total Vitamin D 862.1840(b)(4)). results. ------------------------------------------------------------------------ FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k). Section 510(m)(2) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if, after notice of our intent to exempt and consideration of comments, we determine by order that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness of the device. We believe this may be such a device. The notice of intent to exempt the device from premarket notification requirements is published elsewhere in this issue of the Federal Register. III. Analysis of 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. IV. 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 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 862.1840 to subpart B to read as follows: Sec. 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system. (a) Identification. A total 25-hydroxyvitamin D mass spectrometry test system is a device intended for use in clinical laboratories for the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) in serum or plasma to be used in the assessment of vitamin D sufficiency. (b) Classification. Class II (special controls). The special controls for this device are: (1) The device must have initial and annual standardization verification by a certifying vitamin D standardization organization deemed acceptable by FDA. (2) The 21 CFR 809.10(b) compliant labeling must include detailed descriptions of performance testing conducted to evaluate precision, accuracy, linearity, interference, including the following: (i) Performance testing of device precision must, at a minimum, use intended sample type with Vitamin D concentrations at medically relevant decision points. At least one sample in the precision studies must be an unmodified patient sample. This testing must evaluate repeatability and reproducibility using a protocol from an FDA- recognized standard. (ii) Performance testing of device accuracy must include a minimum of 115 serum or plasma samples that span the measuring interval of the device and compare results of the new device to results of a reference method or a legally marketed standardized mass spectrometry based vitamin D assay. The results must be described in the 21 CFR 809.10(b)(12) compliant labeling of the device. (iii) Interference from vitamin D analogs and metabolites including vitamin D2, vitamin D3, 1-hydroxyvitamin D2, 1-hydroxyvitamin D3, 3- Epi-25-Hydroxyvitamin D2, 3-Epi-25-Hydroxyvitamin D3, 1,25- Dihydroxyvitamin D2, 1,25-Dihydroxyvitamin D3, 3-Epi-1,25- Dihydroxyvitamin D2, and 3-Epi-1,25-Dihydroxyvitamin D3, 25, 26- Dihydroxyvitamin-D3, 24 (R), 25-dihydroxyvitamin-D3, 23 (R), 25- dihydroxyvitamin-D3 must be described in the 21 CFR 809.10(b)(7) compliant labeling of the device. (3) The 21 CFR 809.10(b) compliant labeling must be supported by a reference range study representative of [[Page 51560]] the performance of the device. The study must be conducted using samples collected from apparently healthy male and female adults at least 21 years of age and older from at least 3 distinct climatic regions within the United States in different weather seasons. The ethnic, racial, and gender background of this study population must be representative of the U.S. population demographics. (4) The results of the device as provided in the 21 CFR 809.10(b) compliant labeling and any test report generated must be reported as only total 25-hydroxyvitamin D. Dated: October 31, 2017. Lauren Silvis, Chief of Staff. [FR Doc. 2017-24161 Filed 11-6-17; 8:45 am] BILLING CODE 4164-01-P
![51558 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations
and Cosmetic Act unless added color is Ave., Bldg. 66, Rm. 4550, Silver Spring, receiving an order from FDA classifying
authorized by such standards. MD 20993–0002, 301–796–5866, the device into class III under section
(d) Labeling requirements. The label steven.tjoe@fda.hhs.gov. 513(f)(1) of the FD&C Act, the person
of the color additive and of any SUPPLEMENTARY INFORMATION: then requests a classification under
mixtures prepared therefrom intended section 513(f)(2).
solely or in part for coloring purposes I. Background Under the second procedure, rather
must conform to the requirements of Upon request, FDA has classified the than first submitting a 510(k) and then
§ 70.25 of this chapter. total 25-hydroxyvitamin D mass a request for classification, if the person
(e) Exemption from certification. spectrometry test system as class II determines that there is no legally
Certification of this color additive is not (special controls), which we have marketed device upon which to base a
necessary for the protection of the determined will provide a reasonable determination of substantial
public health, and, therefore, batches assurance of safety and effectiveness. In equivalence, that person requests a
thereof are exempt from the certification addition, we believe this action will classification under section 513(f)(2) of
requirements of section 721(c) of the enhance patients’ access to beneficial the FD&C Act.
Federal Food, Drug, and Cosmetic Act. innovation, in part by reducing Under either procedure for De Novo
regulatory burdens by placing the classification, FDA is required to
Dated: November 1, 2017.
device into a lower device class than the classify the device by written order
Anna K. Abram, within 120 days. The classification will
automatic class III assignment.
Deputy Commissioner for Policy, Planning, The automatic assignment of class III be according to the criteria under
Legislation, and Analysis. occurs by operation of law and without section 513(a)(1) of the FD&C Act.
[FR Doc. 2017–24194 Filed 11–6–17; 8:45 am] any action by FDA, regardless of the Although the device was automatically
BILLING CODE 4164–01–P level of risk posed by the new device. within class III, the De Novo
Any device that was not in commercial classification is considered to be the
distribution before May 28, 1976, is initial classification of the device.
DEPARTMENT OF HEALTH AND automatically classified as, and remains We believe this De Novo classification
HUMAN SERVICES within, class III and requires premarket will enhance patients’ access to
approval unless and until FDA takes an beneficial innovation, in part by
Food and Drug Administration action to classify or reclassify the device reducing regulatory burdens. When FDA
(see 21 U.S.C. 360c(f)(1)). We refer to classifies a device into class I or II via
21 CFR Part 862 these devices as ‘‘postamendments the De Novo process, the device can
[Docket No. FDA–2017–N–4394] devices’’ because they were not in serve as a predicate for future devices of
commercial distribution prior to the that type, including for 510(k)s (see 21
Medical Devices; Clinical Chemistry date of enactment of the Medical Device U.S.C. 360c(f)(2)(B)(i)). As a result, other
and Clinical Toxicology Devices; Amendments of 1976, which amended device sponsors do not have to submit
Classification of the Total 25- the Federal Food, Drug, and Cosmetic a De Novo request or PMA in order to
Hydroxyvitamin D Mass Spectrometry Act (the FD&C Act). market a substantially equivalent device
Test System FDA may take a variety of actions in (see 21 U.S.C. 360c(i), defining
appropriate circumstances to classify or ‘‘substantial equivalence’’). Instead,
AGENCY: Food and Drug Administration,
reclassify a device into class I or II. We sponsors can use the less-burdensome
HHS. may issue an order finding a new device 510(k) process, when necessary, to
ACTION: Final order. to be substantially equivalent under market their device.
SUMMARY: The Food and Drug section 513(i) of the FD&C Act to a
predicate device that does not require II. De Novo Classification
Administration (FDA, the Agency, or On March 20, 2017, AB Sciex LLC
premarket approval (see 21 U.S.C.
we) is classifying the total 25- submitted a request for De Novo
360c(i)). We determine whether a new
hydroxyvitamin D mass spectrometry classification of the Vitamin D 200M
device is substantially equivalent to a
test system into class II (special Assay for the Topaz System. FDA
predicate by means of the procedures
controls). The special controls that reviewed the request in order to classify
for premarket notification under section
apply to the device type are identified the device under the criteria for
510(k) of the FD&C Act and part 807 (21
in this order and will be part of the classification set forth in section
U.S.C. 360(k) and 21 CFR part 807,
codified language for the total 25- 513(a)(1) of the FD&C Act.
respectively).
hydroxyvitamin D mass spectrometry FDA may also classify a device We classify devices into class II if
test system’s classification. We are through ‘‘De Novo’’ classification, a general controls by themselves are
taking this action because we have common name for the process insufficient to provide reasonable
determined that classifying the device authorized under section 513(f)(2) of the assurance of safety and effectiveness,
into class II (special controls) will FD&C Act. Section 207 of the Food and but there is sufficient information to
provide a reasonable assurance of safety Drug Administration Modernization Act establish special controls that, in
and effectiveness of the device. We of 1997 established the first procedure combination with the generals controls,
believe this action will also enhance for De Novo classification (Pub. L. 105– provide reasonable assurance of the
patients’ access to beneficial innovative 115). Section 607 of the Food and Drug safety and effectiveness of the device for
devices, in part by reducing regulatory Administration Safety and Innovation its intended use (see 21 U.S.C.
burdens. Act modified the De Novo application 360c(a)(1)(B)). After review of the
nshattuck on DSK9F9SC42PROD with RULES
DATES: This order is effective November process by adding a second procedure information submitted in the request,
7, 2017. The classification was (Pub. L. 112–144). A device sponsor we determined that the device can be
applicable on May 18, 2017. may utilize either procedure for De classified into class II with the
FOR FURTHER INFORMATION CONTACT: Novo classification. establishment of special controls. FDA
Steven Tjoe, Center for Devices and Under the first procedure, the person has determined that these special
Radiological Health, Food and Drug submits a 510(k) for a device that has controls, in addition to the general
Administration, 10903 New Hampshire not previously been classified. After controls, will provide reasonable
VerDate Sep<11>2014 15:04 Nov 06, 2017 Jkt 244001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\07NOR1.SGM 07NOR1](https://thefederalregister.org/doc/82_FR_51772/page/1.svg)
![51560 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations
the performance of the device. The SUPPLEMENTARY INFORMATION: then requests a classification under
study must be conducted using samples section 513(f)(2).
I. Background
collected from apparently healthy male Under the second procedure, rather
and female adults at least 21 years of age Upon request, FDA has classified the than first submitting a 510(k) and then
and older from at least 3 distinct genetic health risk assessment system as a request for classification, if the person
climatic regions within the United class II (special controls), which we determines that there is no legally
States in different weather seasons. The have determined will provide a marketed device upon which to base a
ethnic, racial, and gender background of reasonable assurance of safety and determination of substantial
this study population must be effectiveness. In addition, we believe equivalence, that person requests a
representative of the U.S. population this action will enhance patients’ access classification under section 513(f)(2) of
demographics. to beneficial innovation, in part by the FD&C Act.
(4) The results of the device as reducing regulatory burdens by placing Under either procedure for De Novo
provided in the 21 CFR 809.10(b) the device into a lower device class than classification, FDA is required to
compliant labeling and any test report the automatic class III assignment. classify the device by written order
generated must be reported as only total The automatic assignment of class III
within 120 days. The classification will
25-hydroxyvitamin D. occurs by operation of law and without
be according to the criteria under
any action by FDA, regardless of the
Dated: October 31, 2017. section 513(a)(1) of the FD&C Act.
level of risk posed by the new device.
Lauren Silvis, Although the device was automatically
Any device that was not in commercial
Chief of Staff. within class III, the De Novo
distribution before May 28, 1976, is
[FR Doc. 2017–24161 Filed 11–6–17; 8:45 am] automatically classified as, and remains classification is considered to be the
within, class III and requires premarket initial classification of the device.
BILLING CODE 4164–01–P
approval unless and until FDA takes an We believe this De Novo classification
action to classify or reclassify the device will enhance patients’ access to
DEPARTMENT OF HEALTH AND (see section 513(f)(1) of the Federal beneficial innovation, in part by
HUMAN SERVICES Food, Drug, and Cosmetic Act (the reducing regulatory burdens. When FDA
FD&C Act) (21 U.S.C. 360c(f)(1))). We classifies a device into class I or II via
Food and Drug Administration refer to these devices as the De Novo process, the device can
‘‘postamendments devices’’ because serve as a predicate for future devices of
21 CFR Part 866 they were not in commercial that type, including for 510(k)s (see 21
distribution prior to the date of U.S.C. 360c(f)(2)(B)(i)). As a result, other
[Docket No. FDA–2017–N–4341]
enactment of the Medical Device device sponsors do not have to submit
Medical Devices; Immunology and Amendments of 1976, which amended a De Novo request or PMA in order to
Microbiology Devices; Classification of the FD&C Act. market a substantially equivalent device
the Genetic Health Risk Assessment FDA may take a variety of actions in (see 21 U.S.C. 360c(i), defining
System appropriate circumstances to classify or ‘‘substantial equivalence’’). Instead,
reclassify a device into class I or II. We sponsors can use the less-burdensome
AGENCY: Food and Drug Administration, may issue an order finding a new device 510(k) process, when necessary, to
HHS. to be substantially equivalent under market their device.
ACTION: Final order. section 513(i) of the FD&C Act to a II. De Novo Classification
predicate device that does not require
SUMMARY: The Food and Drug On June 28, 2016, 23andMe, Inc.
premarket approval. We determine
Administration (FDA, the Agency, or submitted a request for De Novo
whether a new device is substantially
we) is classifying the genetic health risk classification of the 23andMe Personal
equivalent to a predicate by means of
assessment system into class II (special Genome Service (PGS) Test. FDA
the procedures for premarket
controls). The special controls that reviewed the request in order to classify
notification under section 510(k) of the
apply to the device type are identified the device under the criteria for
FD&C Act and part 807 (21 U.S.C. 360(k)
in this order and will be part of the classification set forth in section
and 21 CFR part 807, respectively).
codified language for the genetic health FDA may also classify a device 513(a)(1) of the FD&C Act.
risk assessment system’s classification. through ‘‘De Novo’’ classification, a We classify devices into class II if
We are taking this action because we common name for the process general controls by themselves are
have determined that classifying the authorized under section 513(f)(2) of the insufficient to provide reasonable
device into class II (special controls) FD&C Act. Section 207 of the Food and assurance of safety and effectiveness,
will provide a reasonable assurance of Drug Administration Modernization Act but there is sufficient information to
safety and effectiveness of the device. of 1997 established the first procedure establish special controls that, in
We believe this action will also enhance for De Novo classification (Pub. L. 105– combination with the general controls,
patients’ access to beneficial innovative 115). Section 607 of the Food and Drug provide reasonable assurance of the
devices, in part by reducing regulatory Administration Safety and Innovation safety and effectiveness of the device for
burdens. Act modified the De Novo application its intended use (see 21 U.S.C.
DATES: This order is effective November process by adding a second procedure 360c(a)(1)(B)). After review of the
7, 2017. The classification was (Pub. L. 112–144). A device sponsor information submitted in the request,
applicable on April 6, 2017. may utilize either procedure for De we determined that the device can be
nshattuck on DSK9F9SC42PROD with RULES
FOR FURTHER INFORMATION CONTACT: Novo classification. classified into class II with the
Steven Tjoe, Center for Devices and Under the first procedure, the person establishment of special controls. FDA
Radiological Health, Food and Drug submits a 510(k) for a device that has has determined that these special
Administration, 10903 New Hampshire not previously been classified. After controls, in addition to the general
Ave., Bldg. 66, Rm. 4550, Silver Spring, receiving an order from FDA classifying controls, will provide reasonable
MD 20993–0002, 301–796–5866, the device into class III under section assurance of the safety and effectiveness
steven.tjoe@fda.hhs.gov. 513(f)(1) of the FD&C Act, the person of the device.
VerDate Sep<11>2014 15:04 Nov 06, 2017 Jkt 244001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\07NOR1.SGM 07NOR1](https://thefederalregister.org/doc/82_FR_51772/page/3.svg)
Document Created: 2018-10-25 10:26:21
Document Modified: 2018-10-25 10:26:21
| 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 November 7, 2017. The classification was applicable on May 18, 2017. | |
| 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 51558 |
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