83 FR 52313 - Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 201 (October 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 201 (October 17, 2018)
| Page Range | 52313-52315 | |
| FR Document | 2018-22694 |
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)] [Rules and Regulations] [Pages 52313-52315] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22694] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2018-N-3596] Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel 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 herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel'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 October 17, 2018. The classification was applicable on May 13, 2014. FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4676, Silver Spring, MD, 20993-0002, 301- 796-6217, scott.mcfarland@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the herpes virus nucleic acid- based cutaneous and mucocutaneous lesion panel 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 (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 (21 U.S.C. 360c(i) to a predicate device that does not require premarket approval. 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 (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). 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 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. 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 placed 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 premarket approval application (PMA) 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 For this device, FDA issued an order on February 7, 2014, finding the Lyra\TM\ Direct HSV 1 + 2/VZV Assay not substantially equivalent to a predicate not subject to PMA. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order. On February 21, 2014, Quidel Corporation submitted a request for De Novo classification of the Lyra\TM\ Direct HSV 1 + 2/VZV Assay. 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 general 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 general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on May 13, 2014, FDA issued an order to the requestor classifying the device into class II. FDA [[Page 52314]] is codifying the classification of the device by adding 21 CFR 866.3309. We have named the generic type of device herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel, and it is identified as a qualitative in vitro diagnostic device intended for the simultaneous detection and differentiation of different herpes viruses in cutaneous and mucocutaneous lesion samples from symptomatic patients suspected of Herpetic infections. Negative results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use in cerebrospinal fluid samples. 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--Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Risk of false results.................. Special controls (1) (21 CFR 866.3309(b)(1)), (2) (21 CFR 866.3309(b)(2)), and (3) (21 CFR 866.3309(b)(3)). Failure to correctly interpret test Special controls (4) (21 CFR results. 866.3309(b)(4)) and (5) (21 CFR 866.3309(b)(5)). Failure to correctly operate the Special controls (6) (21 CFR instrument. 866.3309(b)(6)) and (7) (21 CFR 866.3309(b)(7)). ------------------------------------------------------------------------ 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. 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) of the FD&C Act. III. 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. 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 and guidance. 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 the guidance document ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910- 0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulations, have been approved under OMB control number 0910-0073; 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 866 Biologics; Laboratories; 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 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 866.3309 to subpart D to read as follows: Sec. 866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel. (a) Identification. A herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel is a qualitative in vitro diagnostic device intended for the simultaneous detection and differentiation of different herpes viruses in cutaneous and mucocutaneous lesion samples from symptomatic patients suspected of Herpetic infections. Negative results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use in cerebrospinal fluid samples. (b) Classification. Class II (special controls). The special controls for this device are: (1) Premarket notification submissions must include detailed documentation for the device description, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology including primer design and selection. (2) Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (Limit of Detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carry-over, and cross contamination. (3) Premarket notification submissions must include detailed documentation of a clinical study using lesion samples in which Herpes Simplex Virus 1, Herpes Simplex Virus 2, or Varicella Zoster Virus DNA detection was requested. The study must compare the device performance to an appropriate well established reference method. (4) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling. (5) The device labeling must include a limitation statement that reads: ``The device is not intended for use with cerebrospinal fluid or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS).'' (6) Premarket notification submissions must include quality assurance protocols and a detailed documentation for device software, including, but not limited to, standalone [[Page 52315]] software applications and hardware-based devices that incorporate software. (7) The risk management activities performed as part of the manufacturer's 21 CFR 820.30 design controls must document an appropriate end user device training program that will be offered as part of efforts to mitigate the risk of failure to correctly operate the instrument. Dated: October 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22694 Filed 10-16-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 52313
202–741–6030, or go to: http:// a reasonable assurance of safety and classification under section 513(f)(2) of
www.archives.gov/federal-register/cfr/ibr- effectiveness. In addition, we believe the FD&C Act.
locations.html. this action will enhance patients’ access Under either procedure for De Novo
Issued in Des Moines, Washington, on to beneficial innovation, in part by classification, FDA is required to
September 14, 2018. reducing regulatory burdens by placing classify the device by written order
John P. Piccola, the device into a lower device class than within 120 days. The classification will
Acting Director, System Oversight Division, the automatic class III assignment. be according to the criteria under
Aircraft Certification Service. The automatic assignment of class III section 513(a)(1) of the FD&C Act.
[FR Doc. R1–2018–21460 Filed 10–16–18; 8:45 am] occurs by operation of law and without Although the device was automatically
BILLING CODE 1301–00–D
any action by FDA, regardless of the placed within class III, the De Novo
level of risk posed by the new device. classification is considered to be the
Any device that was not in commercial initial classification of the device.
distribution before May 28, 1976, is We believe this De Novo classification
DEPARTMENT OF HEALTH AND will enhance patients’ access to
automatically classified as, and remains
HUMAN SERVICES beneficial innovation, in part by
within, class III and requires premarket
Food and Drug Administration approval unless and until FDA takes an reducing regulatory burdens. When FDA
action to classify or reclassify the device classifies a device into class I or II via
21 CFR Part 866 (see 21 U.S.C. 360c(f)(1)). We refer to the De Novo process, the device can
these devices as ‘‘postamendments serve as a predicate for future devices of
[Docket No. FDA–2018–N–3596] devices’’ because they were not in that type, including for 510(k)s (see 21
commercial distribution prior to the U.S.C. 360c(f)(2)(B)(i)). As a result, other
Medical Devices; Immunology and date of enactment of the Medical Device device sponsors do not have to submit
Microbiology Devices; Classification of Amendments of 1976, which amended a De Novo request or premarket
the Herpes Virus Nucleic Acid-Based the Federal Food, Drug, and Cosmetic approval application (PMA) to market a
Cutaneous and Mucocutaneous Lesion Act (FD&C Act). substantially equivalent device (see 21
Panel FDA may take a variety of actions in U.S.C. 360c(i), defining ‘‘substantial
AGENCY: Food and Drug Administration, appropriate circumstances to classify or equivalence’’). Instead, sponsors can use
HHS. reclassify a device into class I or II. We the less-burdensome 510(k) process,
may issue an order finding a new device when necessary, to market their device.
ACTION: Final order.
to be substantially equivalent under
section 513(i) of the FD&C Act (21 II. De Novo Classification
SUMMARY: The Food and Drug
Administration (FDA or we) is U.S.C. 360c(i) to a predicate device that For this device, FDA issued an order
classifying the herpes virus nucleic does not require premarket approval. on February 7, 2014, finding the LyraTM
acid-based cutaneous and We determine whether a new device is Direct HSV 1 + 2/VZV Assay not
mucocutaneous lesion panel into class II substantially equivalent to a predicate substantially equivalent to a predicate
(special controls). The special controls by means of the procedures for not subject to PMA. Thus, the device
that apply to the device type are premarket notification under section remained in class III in accordance with
identified in this order and will be part 510(k) of the FD&C Act (21 U.S.C. section 513(f)(1) of the FD&C Act when
of the codified language for the herpes 360(k)) and part 807 (21 CFR part 807). we issued the order.
virus nucleic acid-based cutaneous and FDA may also classify a device On February 21, 2014, Quidel
mucocutaneous lesion panel’s through ‘‘De Novo’’ classification, a Corporation submitted a request for De
classification. We are taking this action common name for the process Novo classification of the LyraTM Direct
because we have determined that authorized under section 513(f)(2) of the HSV 1 + 2/VZV Assay. FDA reviewed
classifying the device into class II FD&C Act. Section 207 of the Food and the request in order to classify the
(special controls) will provide a Drug Administration Modernization Act device under the criteria for
reasonable assurance of safety and of 1997 (Pub. L. 105–115) established classification set forth in section
effectiveness of the device. We believe the first procedure for De Novo 513(a)(1) of the FD&C Act.
classification. Section 607 of the Food We classify devices into class II if
this action will also enhance patients’
and Drug Administration Safety and general controls by themselves are
access to beneficial innovative devices,
Innovation Act (Pub. L. 112–144) insufficient to provide reasonable
in part by reducing regulatory burdens.
modified the De Novo application assurance of safety and effectiveness,
DATES: This order is effective October but there is sufficient information to
process by adding a second procedure.
17, 2018. The classification was A device sponsor may utilize either establish special controls that, in
applicable on May 13, 2014. procedure for De Novo classification. combination with the general controls,
FOR FURTHER INFORMATION CONTACT: Under the first procedure, the person provide reasonable assurance of the
Scott McFarland, Center for Devices and submits a 510(k) for a device that has safety and effectiveness of the device for
Radiological Health, Food and Drug not previously been classified. After its intended use (see 21 U.S.C.
Administration, 10903 New Hampshire receiving an order from FDA classifying 360c(a)(1)(B)). After review of the
Ave., Bldg. 66, Rm. 4676, Silver Spring, the device into class III under section information submitted in the request,
MD, 20993–0002, 301–796–6217, 513(f)(1) of the FD&C Act, the person we determined that the device can be
scott.mcfarland@fda.hhs.gov. then requests a classification under classified into class II with the
SUPPLEMENTARY INFORMATION: section 513(f)(2). establishment of special controls. FDA
Under the second procedure, rather
daltland on DSKBBV9HB2PROD with RULES
has determined that these special
I. Background than first submitting a 510(k) and then controls, in addition to general controls,
Upon request, FDA has classified the a request for classification, if the person will provide reasonable assurance of the
herpes virus nucleic acid-based determines that there is no legally safety and effectiveness of the device.
cutaneous and mucocutaneous lesion marketed device upon which to base a Therefore, on May 13, 2014, FDA
panel as class II (special controls), determination of substantial issued an order to the requestor
which we have determined will provide equivalence, that person requests a classifying the device into class II. FDA
VerDate Sep<11>2014 16:09 Oct 16, 2018 Jkt 247001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\FR\FM\17OCR1.SGM 17OCR1](https://thefederalregister.org/doc/83_FR_52514/page/1.svg)
![Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 52315
software applications and hardware- reasonable assurance of safety and classification under section 513(f)(2) of
based devices that incorporate software. effectiveness. In addition, we believe the FD&C Act.
(7) The risk management activities this action will enhance patients’ access Under either procedure for De Novo
performed as part of the manufacturer’s to beneficial innovation, in part by classification, FDA is required to
21 CFR 820.30 design controls must reducing regulatory burdens by placing classify the device by written order
document an appropriate end user the device into a lower device class than within 120 days. The classification will
device training program that will be the automatic class III assignment. be according to the criteria under
offered as part of efforts to mitigate the The automatic assignment of class III section 513(a)(1) of the FD&C Act.
risk of failure to correctly operate the occurs by operation of law and without Although the device was automatically
instrument. any action by FDA, regardless of the placed within class III, the De Novo
Dated: October 12, 2018.
level of risk posed by the new device. classification is considered to be the
Any device that was not in commercial initial classification of the device.
Leslie Kux,
distribution before May 28, 1976, is We believe this De Novo classification
Associate Commissioner for Policy. automatically classified as, and remains
[FR Doc. 2018–22694 Filed 10–16–18; 8:45 am]
will enhance patients’ access to
within, class III and requires premarket beneficial innovation, in part by
BILLING CODE 4164–01–P approval unless and until FDA takes an reducing regulatory burdens. When FDA
action to classify or reclassify the device classifies a device into class I or II via
(see 21 U.S.C. 360c(f)(1)). We refer to the De Novo process, the device can
DEPARTMENT OF HEALTH AND these devices as ‘‘postamendments
HUMAN SERVICES serve as a predicate for future devices of
devices’’ because they were not in that type, including for 510(k)s (see 21
commercial distribution prior to the U.S.C. 360c(f)(2)(B)(i)). As a result, other
Food and Drug Administration date of enactment of the Medical Device device sponsors do not have to submit
Amendments of 1976, which amended a De Novo request or premarket
21 CFR Part 882 the Federal Food, Drug, and Cosmetic approval application to market a
[Docket No. FDA–2018–N–3635] Act (FD&C Act). substantially equivalent device (see 21
FDA may take a variety of actions in
Medical Devices; Neurological U.S.C. 360c(i), defining ‘‘substantial
appropriate circumstances to classify or
Devices; Classification of the External equivalence’’). Instead, sponsors can use
reclassify a device into class I or II. We
Upper Limb Tremor Stimulator the less-burdensome 510(k) process,
may issue an order finding a new device
when necessary, to market their device.
to be substantially equivalent under
AGENCY: Food and Drug Administration,
section 513(i) of the FD&C Act (21 II. De Novo Classification
HHS.
U.S.C. 360c(i)) to a predicate device that
ACTION: Final order. On May 17, 2017, Cala Health, Inc.
does not require premarket approval.
submitted a request for De Novo
SUMMARY: The Food and Drug We determine whether a new device is
substantially equivalent to a predicate classification of the Cala ONE. FDA
Administration (FDA or we) is reviewed the request in order to classify
classifying the external upper limb by means of the procedures for
premarket notification under section the device under the criteria for
tremor stimulator into class II (special classification set forth in section
controls). The special controls that 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807). 513(a)(1) of the FD&C Act.
apply to the device type are identified We classify devices into class II if
FDA may also classify a device
in this order and will be part of the general controls by themselves are
through ‘‘De Novo’’ classification, a
codified language for the external upper insufficient to provide reasonable
common name for the process
limb tremor stimulator’s classification. assurance of safety and effectiveness,
authorized under section 513(f)(2) of the
We are taking this action because we but there is sufficient information to
FD&C Act. Section 207 of the Food and
have determined that classifying the establish special controls that, in
Drug Administration Modernization Act
device into class II (special controls) combination with the general controls,
of 1997 (Pub. L. 105–115) established
will provide a reasonable assurance of provide reasonable assurance of the
the first procedure for De Novo
safety and effectiveness of the device. safety and effectiveness of the device for
classification. Section 607 of the Food
We believe this action will also enhance its intended use (see 21 U.S.C.
and Drug Administration Safety and
patients’ access to beneficial innovative 360c(a)(1)(B)). After review of the
Innovation Act (Pub. L. 112–144)
devices, in part by reducing regulatory information submitted in the request,
modified the De Novo application
burdens. we determined that the device can be
process by adding a second procedure.
DATES: This order is effective October A device sponsor may utilize either classified into class II with the
17, 2018. The classification was procedure for De Novo classification. establishment of special controls. FDA
applicable on April 26, 2018. Under the first procedure, the person has determined that these special
FOR FURTHER INFORMATION CONTACT: submits a 510(k) for a device that has controls, in addition to the general
Kristen Bowsher, Center for Devices and not previously been classified. After controls, will provide reasonable
Radiological Health, Food and Drug receiving an order from FDA classifying assurance of the safety and effectiveness
Administration, 10903 New Hampshire the device into class III under section of the device.
Ave., Bldg. 66, Rm. 2646, Silver Spring, 513(f)(1) of the FD&C Act, the person Therefore, on April 26, 2018, FDA
MD 20993–0002, 301–796–6448, then requests a classification under issued an order to the requester
Kristen.Bowsher@fda.hhs.gov. section 513(f)(2). classifying the device into class II. FDA
Under the second procedure, rather is codifying the classification of the
daltland on DSKBBV9HB2PROD with RULES
SUPPLEMENTARY INFORMATION:
than first submitting a 510(k) and then device by adding 21 CFR 882.5897. We
I. Background a request for classification, if the person have named the generic type of device
Upon request, FDA has classified the determines that there is no legally external upper limb tremor stimulator,
external upper limb tremor stimulator as marketed device upon which to base a and it is identified as a prescription
class II (special controls), which we determination of substantial device that is placed externally on the
have determined will provide a equivalence, that person requests a upper limb and designed to aid in
VerDate Sep<11>2014 16:09 Oct 16, 2018 Jkt 247001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\17OCR1.SGM 17OCR1](https://thefederalregister.org/doc/83_FR_52514/page/3.svg)
Document Created: 2018-10-17 01:47:50
Document Modified: 2018-10-17 01:47:50
| 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 October 17, 2018. The classification was applicable on May 13, 2014. | |
| Contact | Scott McFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4676, Silver Spring, MD, 20993-0002, 301- 796-6217, [email protected] | |
| FR Citation | 83 FR 52313 |
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