81 FR 96364 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 251 (December 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 251 (December 30, 2016)
| Page Range | 96364-96366 | |
| FR Document | 2016-31597 |
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)] [Rules and Regulations] [Pages 96364-96366] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31597] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 11 and 101 [Docket No. FDA-2011-F-0172] RIN 0910-AG57 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; extension of compliance date. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the Federal Register of December 1, 2014, and on May 5, 2016, we stated in the Federal Register that the enforcement of the final rule would begin on May 5, 2017. We are taking this action to clarify and confirm that the compliance date for the final rule is May 5, 2017. DATES: Effective date: This final rule is effective December 30, 2016. Compliance date: Covered establishments must comply with the rule published December 1, 2014 (79 FR 71156) by May 5, 2017. FOR FURTHER INFORMATION CONTACT: Ashley Rulffes, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of December 1, 2014 (79 FR 71156), we published a final rule requiring disclosure of certain nutrition information for standard menu [[Page 96365]] items in certain restaurants and retail food establishments. The final rule, which is now codified at Sec. 101.11 (21 CFR 101.11), implements provisions of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H)) and:Defines terms, including terms that describe criteria for determining whether an establishment is subject to the rule; establishes which foods are subject to the nutrition labeling requirements and which foods are not subject to these requirements; requires that calories for standard menu items be declared on menus and menu boards that list such foods for sale; requires that calories for standard menu items that are self-service or on display be declared on signs adjacent to such foods; requires that written nutrition information for standard menu items be available to consumers who ask to see it; requires, on menus and menu boards, a succinct statement concerning suggested daily caloric intake (succinct statement), designed to help the public understand the significance of the calorie declarations; requires, on menus and menu boards, a statement regarding the availability of the written nutrition information (statement of availability); establishes requirements for determination of nutrient content of standard menu items; establishes requirements for substantiation of nutrient content determined for standard menu items, including requirements for records that a covered establishment must make available to FDA within a reasonable period of time upon request; and establishes terms and conditions under which restaurants and similar retail food establishments not otherwise subject to the rule could elect to be subject to the requirements by registering with FDA. In the preamble to the final rule (79 FR 71156 at 71239 through 71241), we stated that the rule would be effective on December 1, 2015, and also provided a compliance date of December 1, 2015, for covered establishments. The final rule (at Sec. 101.11(a)) defines ``covered establishment'' as a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, e.g., individual franchises) and offering for sale substantially the same menu items, as well as a restaurant or similar retail food establishment that is voluntarily registered to be covered under Sec. 101.11(d). II. Extending the Compliance Date In the Federal Register of July 10, 2015 (80 FR 39675), in response to requests from affected entities, we announced our decision to extend the compliance date for the final rule to December 1, 2016. The final rule requirements are intended to ensure that consumers are provided accurate, clear, and consistent nutrition information for foods sold in covered establishments in a direct and accessible manner to enable consumers to make informed and healthful dietary choices. We stated in that extension that allowing adequate time for covered establishments to fully implement the final rule's requirements, as described in the requests, would help accomplish the primary objective of the final rule and is in the public interest. On December 18, 2015, the President signed the Consolidated Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of the Consolidated Appropriations Act states that none of the funds made available under the Consolidated Appropriations Act may be used to implement, administer, or enforce the final rule entitled ``Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments'' until 1 year after the date we publish a Level 1 guidance with respect to nutrition labeling of standard menu items in restaurants and similar retail food establishments. In the Federal Register of May 5, 2016 (81 FR 27067), we announced the availability of the Level 1 guidance document and stated that enforcement of the final rule published December 1, 2014, would commence on May 5, 2017 (81 FR 27067 at 27068). While FDA made clear that we would not begin enforcing menu labeling requirements prior to May 5, 2017, we did not at that time formally make a change to the compliance date through rulemaking. Therefore, through this final rule, we are clarifying and confirming that the compliance date for the final rule entitled ``Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments,'' codified at Sec. 101.11, is May 5, 2017. III. Economic Analysis of Impacts We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule provides more flexibility by further extending the compliance date for the ``Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments'' final rule (79 FR 71156) (menu labeling final rule), we certify that the final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount. This rule extends the compliance date of the menu labeling final rule by approximately 5 months: From December 1, 2016, to May 5, 2017. The estimated costs and benefits accrued in any given year that the menu labeling rule is in effect, relative to the first year of compliance, does not change; however, because the compliance date is being extended by 5 months, the discounted value of both total costs and total benefits decreases. The principal benefit of this final rule will be the reduction in costs associated with extending the compliance date by 5 months. The principal cost of this final rule will be the reduction in benefits associated with extending the compliance date by 5 months. Extending the compliance date of the menu labeling final rule by 5 months reduces the annualized net benefits (discounted at 3 percent) approximately 3 percent, from $457 million to $442 [[Page 96366]] million. While average annualized net benefits decrease by $15 million, they are still positive. We note that this extension of the compliance date will not have an actual effect on the cost or benefits of the menu labeling rule, because, under section 747 of the Consolidated Appropriations Act, 2016, FDA was not authorized to spend funds to ``implement, administer, or enforce'' the rule until May 5, 2017, a year after the date on which published a Level 1 guidance with respect to nutrition labeling of standard menu items in restaurants and similar retail food establishments. We are presenting the benefits and costs of the menu labeling final rule, which takes effect according to the dates in this rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 1) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. IV. Paperwork Reduction Act This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V. Analysis of Environmental Impact We have determined under 21 CFR 25.30(k) 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. VI. Reference The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA, ``Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date,'' 2015. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/. Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31597 Filed 12-29-16; 8:45 am] BILLING CODE 4164-01-P
![96364 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Rules and Regulations
(c) Applicability shop visit, and the wear is greater than 0.15 Administration (NARA). For information on
This AD applies to Safran Helicopter mm, remove the engine AGB before further the availability of this material at NARA, call
Engines, S.A. Arriel 2B, 2B1, 2C, 2C1, 2C2, flight and replace with a part eligible for 202–741–6030, or go to: http://
2D, 2E, 2S1, and 2S2 turboshaft engines with installation. www.archives.gov/federal-register/cfr/ibr-
an engine accessory gearbox (AGB), part locations.html.
(f) Credit for Previous Action
number 0292120650, with a machined front Issued in Burlington, Massachusetts, on
If you have previously performed a wear
casing. November 29, 2016.
inspection of the engine AGB cover prior to
(d) Unsafe Condition the effective date of this AD in accordance Colleen M. D’Alessandro,
This AD was prompted by a report of an with the instructions given in Turbomeca Manager, Engine & Propeller Directorate,
uncommanded in-flight shutdown (IFSD) of MSB No. 292 72 2861, Version C, dated Aircraft Certification Service.
an Arriel 2S2 engine caused by rupture of the March 9, 2016, or Turbomeca MSB No. 292 [FR Doc. 2016–31695 Filed 12–29–16; 8:45 am]
41-tooth gear, which forms part of the bevel 72 2861, Version B, dated February 2, 2016,
BILLING CODE 4910–13–P
gear in the engine AGB. We are issuing this then you may take credit for that wear
AD to prevent failure of the engine AGB, inspection as the ‘‘most recent’’ wear
uncommanded IFSD, damage to the engine, inspection for the purposes of paragraph
and damage to the helicopter. (e)(4) of this AD. DEPARTMENT OF HEALTH AND
(g) Definition HUMAN SERVICES
(e) Compliance
Comply with this AD within the For the purpose of this AD, an engine shop Food and Drug Administration
compliance times specified, unless already visit is defined as the induction of an engine
done. into the shop for maintenance involving the
separation of any major mating engine 21 CFR Parts 11 and 101
(1) Initial Wear Inspection
(i) For all affected engines, perform a wear flanges, except that the separation of engine [Docket No. FDA–2011–F–0172]
inspection of the engine AGB cover before flanges solely for the purposes of
transportation without subsequent engine RIN 0910–AG57
the engine AGB, module M01, exceeds 850
engine hours (EH) since new or since last maintenance does not constitute an engine
shop visit. Food Labeling; Nutrition Labeling of
overhaul (SLO), or within 50 EHs after April
14, 2016, or before the next flight after the Standard Menu Items in Restaurants
(h) Alternative Methods of Compliance
effective date of this AD, whichever occurs (AMOCs)
and Similar Retail Food
latest. Establishments; Extension of
(ii) Reserved. The Manager, Engine Certification Office, Compliance Date
(2) Repetitive Wear Inspection Intervals FAA, may approve AMOCs for this AD. Use
the procedures found in 14 CFR 39.19 to AGENCY: Food and Drug Administration,
(i) For Arriel 2E engines, repeat the engine
make your request. You may email your HHS.
AGB cover wear inspection within every 800
request to: ANE-AD-AMOC@faa.gov.
EH since last inspection (SLI). ACTION:Final rule; extension of
(ii) For all affected engines, except for (i) Related Information compliance date.
Arriel 2E engines, repeat the engine AGB (1) For more information about this AD,
cover wear inspection within every 600 EH contact Philip Haberlen, Aerospace Engineer, SUMMARY: The Food and Drug
SLI. Engine Certification Office, FAA, Engine & Administration (FDA or we) is
(3) Inspection Criteria Propeller Directorate, 1200 District Avenue, extending the compliance date for the
(i) Use paragraph 2.4.2 of Safran Helicopter Burlington, MA 01803; phone: 781–238– final rule requiring disclosure of certain
Engines, S.A. Mandatory Service Bulletin 7770; fax: 781–238–7199; email: nutrition information for standard menu
(MSB) No. 292 72 2861, Version D, dated philip.haberlen@faa.gov.
September 23, 2016, to do the inspections items in certain restaurants and retail
(2) Refer to MCAI European Aviation food establishments. The final rule
required by paragraphs (e)(1) and (e)(2) of Safety Agency AD 2016–0055R1, dated
this AD. October 11, 2016, for more information. You
appeared in the Federal Register of
(ii) Reserved. may examine the MCAI in the AD docket on December 1, 2014, and on May 5, 2016,
(4) Corrective Actions Based on the Results the Internet at http://www.regulations.gov/ we stated in the Federal Register that
of the Most Recent Wear Inspection document?D=FAA-2015-3753-0006. the enforcement of the final rule would
(i) If the wear measured from the most begin on May 5, 2017. We are taking this
recent wear inspection is 0.15 mm or less, no (j) Material Incorporated by Reference
action to clarify and confirm that the
further action is required. However, you must (1) The Director of the Federal Register compliance date for the final rule is May
still comply with the repetitive inspection approved the incorporation by reference
requirements of paragraph (e)(2) of this AD. 5, 2017.
(IBR) of the service information listed in this
(ii) If the most recent wear inspection was paragraph under 5 U.S.C. 552(a) and 1 CFR DATES: Effective date: This final rule is
performed while the engine was in service, part 51. effective December 30, 2016.
and the wear is greater than 0.15 mm, do the (2) You must use this service information Compliance date: Covered
following: as applicable to do the actions required by establishments must comply with the
(A) If the wear measured from the most this AD, unless the AD specifies otherwise. rule published December 1, 2014 (79 FR
recent wear inspection is greater than 0.15 (i) Safran Helicopter Engines, S.A. 71156) by May 5, 2017.
mm, but 0.30 mm or less, remove the engine Mandatory Service Bulletin No. 292 72 2861,
AGB from service within 200 EH SLI and Version D, dated September 23, 2016. FOR FURTHER INFORMATION CONTACT:
replace with a part eligible for installation. (ii) Reserved. Ashley Rulffes, Center for Food Safety
(B) If the wear measured from the most (3) For Safran Helicopter Engines, S.A. and Applied Nutrition (HFS–820), Food
recent wear inspection is greater than 0.30 service information identified in this AD, and Drug Administration, 5001 Campus
mm, but 0.40 mm or less, remove the engine contact Safran Helicopter Engines, S.A. Dr., College Park, MD 20740, 240–402–
AGB from service within 25 EH SLI and 40220 Tarnos, France; phone: 33 0 5 59 74 2371, email: ashley.rulffes@fda.hhs.gov.
srobinson on DSK5SPTVN1PROD with RULES
replace with a part eligible for installation. 40 00; fax: 33 0 5 59 74 45 15.
SUPPLEMENTARY INFORMATION:
(C) If the wear measured from the most (4) You may view this service information
recent wear inspection is greater than 0.40 at FAA, Engine & Propeller Directorate, 1200 I. Background
mm, remove the engine AGB from service District Avenue, Burlington, MA. For
before further flight and replace with a part information on the availability of this In the Federal Register of December 1,
eligible for installation. material at the FAA, call 781–238–7125. 2014 (79 FR 71156), we published a
(iii) If the most recent wear inspection was (5) You may view this service information final rule requiring disclosure of certain
performed on the engine during an engine at the National Archives and Records nutrition information for standard menu
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![96366 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Rules and Regulations
million. While average annualized net DEPARTMENT OF HEALTH AND Drug Administration Safety and
benefits decrease by $15 million, they HUMAN SERVICES Innovation Act (FDASIA) (Pub. L. 112–
are still positive. We note that this 144), among other amendments,
extension of the compliance date will Food and Drug Administration established a comprehensive system for
not have an actual effect on the cost or the regulation of medical devices
benefits of the menu labeling rule, 21 CFR Part 888 intended for human use. Section 513 of
because, under section 747 of the [Docket No. FDA–2014–N–1205] the FD&C Act (21 U.S.C. 360c)
Consolidated Appropriations Act, 2016, established three categories (classes) of
FDA was not authorized to spend funds Orthopedic Devices; Reclassification devices, reflecting the regulatory
to ‘‘implement, administer, or enforce’’ of Pedicle Screw Systems, Henceforth controls needed to provide reasonable
the rule until May 5, 2017, a year after To Be Known as Thoracolumbosacral assurance of their safety and
the date on which published a Level 1 Pedicle Screw Systems, Including effectiveness. The three categories of
guidance with respect to nutrition Semi-Rigid Systems devices are class I (general controls),
labeling of standard menu items in class II (special controls), and class III
restaurants and similar retail food AGENCY: Food and Drug Administration, (premarket approval).
establishments. We are presenting the HHS. Under section 513(d) of the FD&C Act,
benefits and costs of the menu labeling ACTION: Final order. devices that were in commercial
final rule, which takes effect according distribution before the enactment of the
to the dates in this rule. SUMMARY: The Food and Drug 1976 amendments, May 28, 1976
The full analysis of economic impacts Administration (FDA) is issuing a final (generally referred to as preamendments
is available in the docket for this final order to reclassify pedicle screw devices), are classified after FDA has: (1)
rule (Ref. 1) and at http://www.fda.gov/ systems, a preamendments class III Received a recommendation from a
AboutFDA/ReportsManualsForms/ device (regulated under product code device classification panel (an FDA
Reports/EconomicAnalyses/default.htm. NKB), into class II (special controls), advisory committee); (2) published the
renaming the device panel’s recommendation for comment,
IV. Paperwork Reduction Act
‘‘thoracolumbosacral pedicle screw along with a proposed regulation
This final rule contains no collection systems’’; reclassify dynamic
of information. Therefore, clearance by classifying the device; and (3) published
stabilization systems, a subtype of a final regulation classifying the device.
the Office of Management and Budget pedicle screw systems regulated under
under the Paperwork Reduction Act of FDA has classified most
product code NQP when used as an preamendments devices under these
1995 is not required. adjunct to fusion, into class II (special procedures.
V. Analysis of Environmental Impact controls), renaming this device subtype Devices that were not in commercial
‘‘semi-rigid systems’’; and clarify the distribution prior to May 28, 1976
We have determined under 21 CFR device identification of pedicle screw
25.30(k) that this action is of a type that (generally referred to as
systems to more clearly delineate ‘‘postamendments devices’’) are
does not individually or cumulatively
between rigid pedicle screw systems automatically classified by section
have a significant effect on the human
and semi-rigid systems. FDA is 513(f) of the FD&C Act into class III
environment. Therefore, neither an
finalizing this action based on a without any FDA rulemaking process.
environmental assessment nor an
reevaluation of information pertaining Those devices remain in class III and
environmental impact statement is
to the device type. require premarket approval unless, and
required.
DATES: This order is effective on until, the device is reclassified into class
VI. Reference December 30, 2016. See further I or II or FDA issues an order finding the
The following reference is on display discussion in section V, device to be substantially equivalent, in
in the Division of Dockets Management ‘‘Implementation Strategy.’’ accordance with section 513(i) of the
(HFA–305), Food and Drug FOR FURTHER INFORMATION CONTACT: FD&C Act, to a predicate device that
Administration, 5630 Fishers Lane, Rm. Constance P. Soves, Center for Devices does not require premarket approval.
1061, Rockville, MD 20852, and is and Radiological Health, Food and Drug The Agency determines whether new
available for viewing by interested Administration, 10903 New Hampshire devices are substantially equivalent to
persons between 9 a.m. and 4 p.m., Ave., Bldg. 66, Rm. 1437, Silver Spring, predicate devices by means of
Monday through Friday; it is also MD 20993, 301–796–6951, premarket notification procedures in
available electronically at https:// Constance.Soves@fda.hhs.gov. section 510(k) of the FD&C Act (21
www.regulations.gov. FDA has verified SUPPLEMENTARY INFORMATION: U.S.C. 360(k)) and part 807 (21 Code of
the Web site addresses, as of the date Federal Regulations (CFR) part 807).
this document publishes in the Federal I. Background—Regulatory Authorities A preamendments device that has
Register, but Web sites are subject to The Federal Food, Drug, and Cosmetic been classified into class III and devices
change over time. Act (the FD&C Act), as amended by the found substantially equivalent by means
1. FDA, ‘‘Food Labeling; Nutrition Labeling Medical Device Amendments of 1976 of premarket notification (510(k))
of Standard Menu Items in Restaurants (the 1976 amendments) (Pub. L. 94– procedures to such a preamendments
and Similar Retail Food Establishments; 295), the Safe Medical Devices Act of device or to a device within that type
Extension of Compliance Date,’’ 2015. 1990 (Pub. L. 101–629), the Food and (both the preamendments and
Available at: http://www.fda.gov/ Drug Administration Modernization Act substantially equivalent devices are
AboutFDA/ReportsManualsForms/
srobinson on DSK5SPTVN1PROD with RULES
Reports/EconomicAnalyses/. of 1997 (Pub. L. 105–115), the Medical referred to as preamendments class III
Device User Fee and Modernization Act devices) may be marketed without
Dated: December 23, 2016. of 2002 (Pub. L. 107–250), the Medical submission of a premarket approval
Leslie Kux, Devices Technical Corrections Act (Pub. application (PMA) until FDA issues a
Associate Commissioner for Policy. L. 108–214), the Food and Drug final order under section 515(b) of the
[FR Doc. 2016–31597 Filed 12–29–16; 8:45 am] Administration Amendments Act of FD&C Act (21 U.S.C. 360e(b)) requiring
BILLING CODE 4164–01–P 2007 (Pub. L. 110–85), and the Food and premarket approval.
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Document Created: 2016-12-30 05:16:05
Document Modified: 2016-12-30 05:16:05
| 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 rule; extension of compliance date. | |
| Dates | Effective date: This final rule is effective December 30, 2016. Compliance date: Covered establishments must comply with the rule published December 1, 2014 (79 FR 71156) by May 5, 2017. | |
| Contact | Ashley Rulffes, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371, email: [email protected] | |
| FR Citation | 81 FR 96364 | |
| RIN Number | 0910-AG57 | |
| CFR Citation | 21
CFR
101 21 CFR 11 |
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