80 FR 72589 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 224 (November 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 224 (November 20, 2015)
| Page Range | 72589-72591 | |
| FR Document | 2015-29633 |
[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)] [Rules and Regulations] [Pages 72589-72591] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29633] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 890 [Docket No. FDA-2015-P-1197] Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. These devices are used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. This order exempts electric positioning chairs, class II devices, from premarket notification, subject to certain conditions for exemption. This exemption from premarket notification, subject to these conditions (and the limitations in the physical medicine devices limitations of exemptions from premarket notification section of the device regulations), is immediately in effect for electric positioning chairs. FDA is publishing this order in accordance with the exemption from class II premarket notification section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). DATES: This order is effective November 20, 2015. FOR FURTHER INFORMATION CONTACT: John Marszalek, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1427, Silver Spring, MD 20993, 301-796-7067. SUPPLEMENTARY INFORMATION: I. Statutory Background Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its implementing regulations (21 CFR part 807) require persons who propose to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use to submit a premarket notification (510(k)) to FDA. The device may not be marketed until FDA finds it ``substantially equivalent'' within the meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device that does not require premarket approval. On November 21, 1997, the President signed into law the Food and Drug Administration Modernization Act of 1997 (FDAMA). Section 206 of FDAMA added section 510(m) to the FD&C Act. Section 510(m)(1) of the FD&C Act requires FDA, within 60 days after enactment of FDAMA, to publish in the Federal Register a list of each type of class II device that does not require a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. Section 510(m) of the FD&C Act further provides that a 510(k) will no longer be required for these devices upon the date of publication of the list in the Federal Register. FDA published that list in the Federal Register of January 21, 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that FDA may exempt a device from premarket notification requirements on its own initiative, or upon petition of an interested person, if FDA determines that a 510(k) is not necessary to assure the safety and effectiveness of the device. This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. FDA must publish in the Federal Register its final determination regarding the exemption of the device that was the subject of the notice. If FDA fails to respond to a petition under this section within 180 days of receiving it, the petition shall be deemed granted. II. Criteria for Exemption There are a number of factors FDA may consider to determine whether a 510(k) is necessary to assure the safety and effectiveness of a class II device. These factors are discussed in the guidance that the Agency issued on February 19, 1998, entitled ``Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff'' (Class II 510(k) Exemption Guidance). That guidance can be obtained through the Internet on the Center for Devices and Radiological Health home page at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by sending an email request to [email protected] to receive a copy of the document. Please use the document number 159 to identify the guidance you are requesting. III. Device Description Electric positioning chairs are devices with a motorized positioning control that are intended for medical purposes and that can be adjusted to various positions. Existing legally marketed devices have identified a range of specific procedures or conditions for which an electric positioning chair could be used to provide stability and to alter postural positions (e.g., muscular dystrophy, Parkinson's syndrome, or joint replacements). The devices are primarily intended to provide stability and a controlled lift from a seated position to a standing position, while supporting the patient's weight (alter postural positions). The device consists of a frame (where the user would sit) and a lift mechanism, and may also allow the patient to recline in the device. IV. Petition On April 10, 2015, FDA received a petition requesting an exemption from premarket notification for electric positioning chair devices. (See Docket No. FDA-2015-P-1197.) These devices are currently classified under 21 CFR 890.3110 Electric positioning chair. In the Federal Register of June 12, 2015 (80 FR 33525), FDA published a notice announcing that this petition had been received and provided opportunity for interested persons to submit comments on the petition by July 13, 2015. FDA received no comments. FDA has assessed the need for 510(k) clearance for this type of device using the criteria laid out in the Class II 510(k) Exemption Guidance and in the January 21, 1998, notice (63 FR 3142 at 3143). Based on its review, FDA believes that premarket notification is not necessary to assure the safety and effectiveness of the device, as long as certain conditions are met. FDA believes that the risks posed by the device (such as instability, entrapment, use error, falls and associated injuries, battery/electrical/mechanical failure, pressure sores, bruising, burns, electric shock, and [[Page 72590]] electromagnetic incompatibility/interference) and the characteristics of the device necessary for its safe and effective performance (such as safety features, weight capacity, power source, drive mechanism/ actuator, and user controls) are well established. Moreover, FDA believes that changes in the device that could affect safety and effectiveness will be readily detectable by certain types of routine analysis and non-clinical testing, such as those detailed in certain consensus standards. Therefore, after reviewing the petition, FDA has determined that premarket notification is not necessary to assure the safety and effectiveness of electric positioning chairs, as long as the conditions for 510(k) exemption in section V are met. FDA responded to the petition by letter dated October 9, 2015, to inform the petitioner of this decision within the 180-day timeframe under section 510(m)(2) of the FD&C Act. V. Conditions for Exemption This final order provides conditions for exemption from premarket notification. The following conditions must be met for the device to be 510(k)-exempt: (1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure; (2) appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety; (3) appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device; (4) appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device; (5) appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI ES60601- 1: ``Medical Electrical Equipment--Part 1: General Requirements for Basic Safety and Essential Performance,'' and ANSI/AAMI/IEC 60601-1-2, ``Medical Electrical Equipment--Part 1-2: General Requirements for Basic Safety and Essential Performance--Collateral Standard: Electromagnetic Disturbances--Requirements and Tests'') must validate electromagnetic compatibility and electrical safety; (6) appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, ``Biological Evaluation of Medical Devices--Part 1: Evaluation and Testing Within a Risk Management Process,'' ANSI/AAMI/ISO 10993-5, ``Biological Evaluation of Medical Devices--Part 5: Tests for In Vitro Cytotoxicity,'' and ANSI/AAMI/ISO 10993-10, ``Biological Evaluation of Medical Devices--Part 10: Tests for Irritation and Skin Sensitization'') must validate that the skin-contacting components of the device are biocompatible; (7) appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, ``Medical Device Software--Software Life Cycle Processes'') must validate the software life cycle and that all processes, activities, and tasks are implemented and documented; (8) appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable; (9) appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and (10) adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment. Firms are now exempt from 510(k) requirements for electric positioning chairs as long as they meet these conditions of exemption, subject to the limitations in 21 CFR 890.9. Firms must comply with the conditions for exemption or submit and receive clearance for a 510(k) prior to marketing. VI. Environmental Impact The Agency has determined under 21 CFR 25.30(h) 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. VII. Paperwork Reduction Act of 1995 This final order refers to previously approved collections of information found in 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 21 CFR part 801, regarding medical device labeling, have been approved under OMB control number 0910-0485 and the collections of information in 21 CFR part 820, regarding the quality system regulation, have been approved under OMB control number 0910- 0073. List of Subjects in 21 CFR Part 890 Medical devices, Physical medicine devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 890 is amended as follows: PART 890--PHYSICAL MEDICINE DEVICES 0 1. The authority citation for 21 CFR part 890 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. In Sec. 890.3110, revise paragraph (b) to read as follows: Sec. 890.3110 Electric positioning chair. * * * * * (b) Classification. Class II. The electric positioning chair is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to Sec. 890.9 and the following conditions for exemption: (1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure; (2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety; (3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device; (4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device; (5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601- 1, ``Medical Electrical Equipment--Part 1: General Requirements for Basic Safety and Essential Performance,'' and ANSI/AAMI/IEC 60601-1-2, ``Medical Electrical Equipment--Part 1-2: General Requirements for Basic Safety and Essential Performance--Collateral Standard: Electromagnetic Disturbances--Requirements and Tests'') must validate electromagnetic compatibility and electrical safety; (6) Appropriate analysis and non-clinical testing (such as that outlined in [[Page 72591]] the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, ``Biological Evaluation of Medical Devices--Part 1: Evaluation and Testing Within a Risk Management Process,'' ANSI/AAMI/ISO 10993-5, ``Biological Evaluation of Medical Devices--Part 5: Tests for In Vitro Cytotoxicity,'' and ANSI/AAMI/ISO 10993-10, ``Biological Evaluation of Medical Devices--Part 10: Tests for Irritation and Skin Sensitization'') must validate that the skin-contacting components of the device are biocompatible; (7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, ``Medical Device Software--Software Life Cycle Processes'') must validate the software life cycle and that all processes, activities, and tasks are implemented and documented; (8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable; (9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and (10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment. Dated: November 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29633 Filed 11-19-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Rules and Regulations 72589
radiation low-level disinfection in the Administration, 10903 New Hampshire for Class II Device Exemptions From
chamber device. Ave., Bldg. 66, Rm. 1427, Silver Spring, Premarket Notification, Guidance for
(x) Description of the required MD 20993, 301–796–7067. Industry and CDRH Staff’’ (Class II
preparation of equipment for SUPPLEMENTARY INFORMATION: 510(k) Exemption Guidance). That
disinfection in the UV radiation guidance can be obtained through the
chamber device. I. Statutory Background Internet on the Center for Devices and
(xi) Identification of the specific Section 510(k) of the FD&C Act (21 Radiological Health home page at
microbes used in successful U.S.C. 360(k)) and its implementing http://www.fda.gov/MedicalDevices/
performance testing of the device. regulations (21 CFR part 807) require DeviceRegulationandGuidance/
(xii) Validated instructions for persons who propose to begin the GuidanceDocuments/ucm080198.htm or
cleaning and disinfection of the device. introduction or delivery for introduction by sending an email request to CDRH-
Dated: November 17, 2015. into interstate commerce for commercial Guidance@fda.hhs.gov to receive a copy
Leslie Kux,
distribution of a device intended for of the document. Please use the
human use to submit a premarket document number 159 to identify the
Associate Commissioner for Policy.
notification (510(k)) to FDA. The device guidance you are requesting.
[FR Doc. 2015–29660 Filed 11–19–15; 8:45 am] may not be marketed until FDA finds it
III. Device Description
BILLING CODE 4164–01–P ‘‘substantially equivalent’’ within the
meaning of section 513(i) of the FD&C Electric positioning chairs are devices
Act (21 U.S.C. 360c(i)) to a legally with a motorized positioning control
DEPARTMENT OF HEALTH AND marketed device that does not require that are intended for medical purposes
HUMAN SERVICES premarket approval. and that can be adjusted to various
On November 21, 1997, the President positions. Existing legally marketed
Food and Drug Administration devices have identified a range of
signed into law the Food and Drug
Administration Modernization Act of specific procedures or conditions for
21 CFR Part 890 1997 (FDAMA). Section 206 of FDAMA which an electric positioning chair
[Docket No. FDA–2015–P–1197] added section 510(m) to the FD&C Act. could be used to provide stability and
Section 510(m)(1) of the FD&C Act to alter postural positions (e.g.,
Medical Devices; Exemption From requires FDA, within 60 days after muscular dystrophy, Parkinson’s
Premarket Notification; Class II enactment of FDAMA, to publish in the syndrome, or joint replacements). The
Devices; Electric Positioning Chair Federal Register a list of each type of devices are primarily intended to
class II device that does not require a provide stability and a controlled lift
AGENCY: Food and Drug Administration,
report under section 510(k) of the FD&C from a seated position to a standing
HHS.
Act to provide reasonable assurance of position, while supporting the patient’s
ACTION: Final order. safety and effectiveness. Section 510(m) weight (alter postural positions). The
SUMMARY: The Food and Drug of the FD&C Act further provides that a device consists of a frame (where the
Administration (FDA or the Agency) is 510(k) will no longer be required for user would sit) and a lift mechanism,
publishing an order granting a petition these devices upon the date of and may also allow the patient to
requesting exemption from premarket publication of the list in the Federal recline in the device.
notification requirements for electric Register. FDA published that list in the
IV. Petition
positioning chair devices. An electric Federal Register of January 21, 1998 (63
FR 3142). On April 10, 2015, FDA received a
positioning chair is a device with a
Section 510(m)(2) of the FD&C Act petition requesting an exemption from
motorized positioning control that is
provides that FDA may exempt a device premarket notification for electric
intended for medical purposes and that
from premarket notification positioning chair devices. (See Docket
can be adjusted to various positions.
requirements on its own initiative, or No. FDA–2015–P–1197.) These devices
These devices are used to provide
upon petition of an interested person, if are currently classified under 21 CFR
stability for patients with athetosis
FDA determines that a 510(k) is not 890.3110 Electric positioning chair.
(involuntary spasms) and to alter In the Federal Register of June 12,
necessary to assure the safety and
postural positions. This order exempts 2015 (80 FR 33525), FDA published a
effectiveness of the device. This section
electric positioning chairs, class II notice announcing that this petition had
requires FDA to publish in the Federal
devices, from premarket notification, been received and provided opportunity
Register a notice of intent to exempt a
subject to certain conditions for for interested persons to submit
device, or of the petition, and to provide
exemption. This exemption from comments on the petition by July 13,
a 30-day comment period. FDA must
premarket notification, subject to these 2015. FDA received no comments.
publish in the Federal Register its final
conditions (and the limitations in the FDA has assessed the need for 510(k)
determination regarding the exemption
physical medicine devices limitations of clearance for this type of device using
of the device that was the subject of the
exemptions from premarket notification the criteria laid out in the Class II 510(k)
notice. If FDA fails to respond to a
section of the device regulations), is Exemption Guidance and in the January
petition under this section within 180
immediately in effect for electric 21, 1998, notice (63 FR 3142 at 3143).
days of receiving it, the petition shall be
positioning chairs. FDA is publishing Based on its review, FDA believes that
deemed granted.
this order in accordance with the premarket notification is not necessary
exemption from class II premarket II. Criteria for Exemption to assure the safety and effectiveness of
notification section of the Federal Food, There are a number of factors FDA the device, as long as certain conditions
tkelley on DSK3SPTVN1PROD with RULES
Drug, and Cosmetic Act (the FD&C Act). may consider to determine whether a are met. FDA believes that the risks
DATES: This order is effective November 510(k) is necessary to assure the safety posed by the device (such as instability,
20, 2015. and effectiveness of a class II device. entrapment, use error, falls and
FOR FURTHER INFORMATION CONTACT: John These factors are discussed in the associated injuries, battery/electrical/
Marszalek, Center for Devices and guidance that the Agency issued on mechanical failure, pressure sores,
Radiological Health, Food and Drug February 19, 1998, entitled ‘‘Procedures bruising, burns, electric shock, and
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![Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Rules and Regulations 72591
the currently FDA-recognized editions FOR FURTHER INFORMATION CONTACT: Finally, the problems the commenter
of ANSI/AAMI/ISO 10993–1, Michael Holly, Passport Services, describes are very rare among U.S.
‘‘Biological Evaluation of Medical Bureau of Consular Affairs; 202–485– passport holders. The average U.S.
Devices—Part 1: Evaluation and Testing 6373: PassportRules@state.gov. passport holder uses six or fewer visa
Within a Risk Management Process,’’ SUPPLEMENTARY INFORMATION: pages. Ninety-seven percent of all U.S.
ANSI/AAMI/ISO 10993–5, ‘‘Biological passport holders will have used 17
Evaluation of Medical Devices—Part 5: Background pages or less by the time they renew
Tests for In Vitro Cytotoxicity,’’ and On April 29, 2015, the Department of their passports. Less than one percent of
ANSI/AAMI/ISO 10993–10, ‘‘Biological State published a NPRM that proposed U.S. passport holders will have used
Evaluation of Medical Devices—Part 10: eliminating the visa page insert service more than 32 pages when they renew
Tests for Irritation and Skin for regular fee passport book holders their passports. On average, people who
Sensitization’’) must validate that the beginning January 1, 2016. See 80 FR apply for visa page inserts for a U.S.
skin-contacting components of the 23754. As explained in the NPRM, the passport do so seven years after the
device are biocompatible; effective date of this rule coincides with passport was issued and 17 percent of
(7) Appropriate analysis and non- when the Department expects to begin these individuals had the smaller
clinical testing (such as that outlined in issuing an updated version of the Next passport book to begin with.
the currently FDA-recognized editions Generation Passport book. The primary Accordingly, while the Department
of IEC 62304, ‘‘Medical Device reason for eliminating visa page inserts certainly understands the commenter’s
Software—Software Life Cycle is to protect the integrity of the Next concerns, it still expects the overall
Processes’’) must validate the software Generation Passport books. Further impact of this rule on U.S. passport
life cycle and that all processes, discussion of the reasons for the rule is holders to be minimal, and to be
activities, and tasks are implemented in the NRPM. outweighed by the security concerns
and documented; Public Comments discussed in the NPRM.
(8) Appropriate analysis and non-
clinical testing must validate that the The Department received only one Regulatory Findings
device components are found to be non- public comment in response to the The Regulatory Findings included in
flammable; notice of proposed rulemaking. The the NPRM are incorporated herein. See
(9) Appropriate analysis and non- following analysis addresses the 80 FR at 23755.
clinical testing must validate that the comment.
battery in the device (if applicable) The commenter expressed concern List of Subjects in 22 CFR Parts 22 and
performs as intended over the that eliminating visa page inserts would 51
anticipated service life of the device; be a considerable inconvenience. The Consular services, Fees, Passports and
and commenter wrote that due to the extent visas.
(10) Adequate patient labeling is of his travels, eliminating visa page
For the reasons stated in the
provided to the user to document proper inserts would require him to renew his
preamble, the Department of State
use and maintenance of the device to passport every three or four years, even
amends 22 CFR parts 22 and 51 as
ensure safe use of the device by the if he is issued the larger 52-page
follows:
patient in the intended use passport book. The commenter also
environment. wrote that running out of visa pages in PART 22—SCHEDULE OF FEES FOR
his passport would cause some of his CONSULAR SERVICES—
Dated: November 16, 2015. multi-year visas to expire, requiring him
Leslie Kux, DEPARTMENT OF STATE AND
to renew his visas early or possibly FOREIGN SERVICE
Associate Commissioner for Policy. carry his expired U.S. passport until the
[FR Doc. 2015–29633 Filed 11–19–15; 8:45 am] visas in it expire. ■ 1. The authority citation for part 22
BILLING CODE 4164–01–P The Department recognizes that continues to read as follows:
eliminating visa page inserts may pose
Authority: 8 U.S.C 1101 note, 1153 note,
an inconvenience to a very small 1183a note, 1351, 1351 note, 1714, 1714 note;
DEPARTMENT OF STATE number of U.S. passport holders whose 10 U.S.C. 2602(c); 11 U.S.C. 1157 note; 22
travel requires the issuance of multiple U.S.C. 214, 214 note, 1475e, 2504(a), 4201,
22 CFR Parts 22 and 51 visas. The Department has a policy in 4206, 4215, 4219, 6551; 31 U.S.C. 9701;
[Public Notice: 9350] place to permit the issuance of a second Executive Order 10718, 22 FR 4632;
regular fee passport to individuals who Executive Order 11295, 31 FR 10603.
RIN 1400–AD76 require their first passport books for
§ 22.1 [Amended]
travel while their visa applications are
Elimination of Visa Page Insert Service ■ 2. The table in § 22.1 is amended by
pending with foreign governments. (See
for U.S. Passport Book Holders removing and reserving item 2c.
7 FAM 1310 Appendix R c(2) http://
AGENCY: Department of State. www.state.gov/documents/organization/
94669.pdf). PART 51—PASSPORTS
ACTION: Final rule.
The commenter questioned if visa
SUMMARY: On April 29, 2015, the ■ 3. The authority citation for part 51
page inserts present a genuine security
Department of State published a notice continues to read as follows:
concern. As described in the NPRM, an
of proposed rulemaking (NPRM) that interagency working group studied the Authority: 8 U.S.C. 1504; 18 U.S.C. 1621;
proposed eliminating the visa page issue and determined that the 22 U.S.C. 211a, 212, 213, 213n (Pub. L. 106–
tkelley on DSK3SPTVN1PROD with RULES
insert service for regular fee passport elimination of visa page inserts added 113 Div. B, Sec. 1000(a)(7) [Div. A, Title II,
book holders beginning January 1, 2016. Sec. 236], 113 Stat. 1536, 1501A–430); 214,
value to the security features of visa 214a, 217a, 218, 2651a, 2671(d)(3), 2705,
The Department is finalizing the page inserts that far outweighed the 2714, 2721, & 3926; 26 U.S.C. 6039E; 31
proposed rule without change. inconvenience caused by the U.S.C. 9701; 42 U.S.C. 652(k) [Div. B, Title
DATES: This rule is effective January 1, elimination of this service, for which V of Pub. L. 103–317, 108 Stat. 1760]; E.O.
2016. there is very limited demand. 11295, Aug. 6, 1966, FR 10603, 3 CFR, 1966–
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Document Created: 2015-12-14 13:58:48
Document Modified: 2015-12-14 13:58:48
| 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 20, 2015. | |
| Contact | John Marszalek, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1427, Silver Spring, MD 20993, 301-796-7067. | |
| FR Citation | 80 FR 72589 | |
| CFR Associated | Medical Devices and Physical Medicine Devices |
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