80 FR 42723 - Regulatory Hearing Before the Food and Drug Administration; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 138 (July 20, 2015)

Page Range		42723-42723
FR Document		2015-17714

The Food and Drug Administration (FDA) is updating an authority citation for the Code of Federal Regulations. This action is technical in nature and is intended to provide accuracy of the Agency's regulations.

Federal Register, Volume 80 Issue 138 (Monday, July 20, 2015)

[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Rules and Regulations]
[Page 42723]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 16

[Docket No. FDA-2015-N-0011]


Regulatory Hearing Before the Food and Drug Administration; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is updating an 
authority citation for the Code of Federal Regulations. This action is 
technical in nature and is intended to provide accuracy of the Agency's 
regulations.

DATES: This rule is effective July 20, 2015.

FOR FURTHER INFORMATION CONTACT: Mary E. Kennelly, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 4338, Silver Spring, MD 20993-0002, 240-402-9577, 
[email protected].

SUPPLEMENTARY INFORMATION: In a previous rulemaking, the authority 
citation for 21 CFR part 16 was inadvertently altered to omit 28 U.S.C. 
2112 and changed 21 U.S.C. 467f to 21 U.S.C. 467F. FDA is reversing 
those changes such that 28 U.S.C. 2112 and 21 U.S.C. 467f are included 
in the list of authority citations for 21 CFR part 16.

List of Subjects in 21 CFR Part16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
16 is amended as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for 21 CFR part 16 is revised to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17714 Filed 7-17-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations 42723

By direction of the Commission, DEPARTMENT OF HEALTH AND POSTAL REGULATORY COMMISSION
Commissioner Ohlhausen dissenting. HUMAN SERVICES
Donald S. Clark, 39 CFR Part 3020
Secretary. Food and Drug Administration [Docket Nos. MC2010–21 and CP2010–36]
Note: The following dissent will not appear 21 CFR Part 16
in the Code of Federal Regulations. Update to Product Lists
[Docket No. FDA–2015–N–0011] AGENCY: Postal Regulatory Commission.
Dissenting Statement of Commissioner ACTION: Final rule.
Maureen K. Ohlhausen Regulatory Hearing Before the Food
and Drug Administration; Technical SUMMARY: The Commission is updating
I voted against the Commission’s
Amendment the product lists. This action reflects a
Final Revised Interpretations of the
Magnuson-Moss Warranty Act (MMWA) AGENCY: Food and Drug Administration, publication policy adopted by
Rule because it retains Rule 703.5(j)’s HHS. Commission order. The referenced
prohibition on pre-dispute mandatory policy assumes periodic updates. The
Final rule; technical
ACTION:
updates are identified in the body of
binding arbitration.1 amendment.
Since the last Rule review in 1997, this document. The product lists, which
two federal appellate courts have held SUMMARY: The Food and Drug is re-published in its entirety, includes
that the MMWA does not prohibit Administration (FDA) is updating an these updates.
binding arbitration.2 Noting the federal authority citation for the Code of DATES: Effective date: July 20, 2015.
policy favoring arbitration expressed in Federal Regulations. This action is Applicability dates: March 31, 2015,
the Federal Arbitration Act (FAA),3 technical in nature and is intended to Parcel Return Service Contract 6
these courts concluded that the provide accuracy of the Agency’s (MC2015–41 and CP2015–53); April 8,
MMWA’s statutory language and regulations. 2015, Priority Mail Contract 121
legislative history did not overcome the (MC2015–43 and CP2015–54); April 8,
DATES: This rule is effective July 20, 2015, Parcel Select Contract 9 (MC2015–
presumption in favor of arbitration and 2015.
that the purposes of the MMWA and the 44 and CP2015–55); April 8, 2015,
FAA were not in inherent conflict. The FOR FURTHER INFORMATION CONTACT: Priority Mail & First-Class Package
courts also declined to give the Mary E. Kennelly, Office of Regulatory Service Contract 3 (MC2015–45 and
Commission’s contrary interpretation Affairs, Food and Drug Administration, CP2015–56); April 21, 2015, Priority
Chevron deference.4 Although some 10903 New Hampshire Ave., Bldg. 32, Mail Express & Priority Mail Contract 17
lower courts have reached a different Rm. 4338, Silver Spring, MD 20993– (MC2015–47 and CP2015–58); April 21,
conclusion, there is no circuit court 0002, 240–402–9577, 2015, Priority Mail Contract 122
precedent upholding the Commission’s FDASIAImplementationORA@ (MC2015–46 and CP2015–57); May 1,
interpretation of the MMWA in Rule fda.hhs.gov. 2015, Priority Mail & First-Class Package
703.5(j). Additionally, in several recent Service Contract 4 (MC2015–48 and
SUPPLEMENTARY INFORMATION: In a CP2015–60); May 12, 2015, Priority Mail
cases, the Supreme Court has indicated previous rulemaking, the authority
a strong preference for arbitration.5 Express & Priority Mail Contract 18
citation for 21 CFR part 16 was (MC2015–49 and CP2015–61); May 27,
The courts have sent a clear signal inadvertently altered to omit 28 U.S.C.
that the Commission’s position that 2015, Global Expedited Package
2112 and changed 21 U.S.C. 467f to 21 Services Contracts Non-Published Rates
MMWA prohibits binding arbitration is U.S.C. 467F. FDA is reversing those
no longer supportable.6 When faced 6 (MC2015–23 and CP2015–65); May 28,
changes such that 28 U.S.C. 2112 and 21 2015, Parcel Return Service Contract 7
with such a signal, the Commission U.S.C. 467f are included in the list of
should not reaffirm the rule in question. (MC2015–50 and CP2015–72); May 28,
authority citations for 21 CFR part 16. 2015, Parcel Return Service Contract 8
I therefore respectfully dissent.
[FR Doc. 2015–14065 Filed 7–17–15; 8:45 am] List of Subjects in 21 CFR Part16 (MC2015–51 and CP2015–73); June 9,
2015, Priority Mail Contract 124
BILLING CODE 6750–01–P Administrative practice and (MC2015–53 and CP2015–81); June 9,
procedure. 2015, Priority Mail Contract 123
1 I do not object to the other final actions taken
Therefore, under the Federal Food, (MC2015–52 and CP2015–80); June 16,
in this review.
2 See Walton v. Rose Mobile Homes, LLC, 298 Drug, and Cosmetic Act and under 2015, Priority Mail Contract 125
F.3d 470 (5th Cir. 2002); Davis v. Southern Energy authority delegated to the Commissioner (MC2015–54 and CP2015–82).
Homes, Inc., 305 F.3d 1268 (11th Cir. 2002). of Food and Drugs, 21 CFR part 16 is FOR FURTHER INFORMATION CONTACT:
3 9 U.S.C. 1. See Shearson/Am. Express Inc. v.
amended as follows: David A. Trissell, General Counsel, at
McMahon, 482 U.S. 220 (1987) (noting that the
presumption of the FAA is that arbitration is PART 16—REGULATORY HEARING 202–789–6800.
preferable and Congress must clearly override that SUPPLEMENTARY INFORMATION: This
presumption if it is to be disregarded). BEFORE THE FOOD AND DRUG
4 Chevron U.S.A., Inc. v. Natural Resources ADMINISTRATION document identifies updates to the
Defense Council, Inc., 467 U.S. 837 (1984) (holding product lists, which appear as 39 CFR
that courts defer to an agency’s interpretation of a ■ 1. The authority citation for 21 CFR Appendix A to Subpart A of Part 3020—
statute if ‘‘(1) Congress has not spoken directly to part 16 is revised to read as follows: Mail Classification Schedule.
the issue; and (2) the agency’s interpretation ‘is Publication of the updated product lists
based on a permissible construction of the Authority: 15 U.S.C. 1451–1461; 21 U.S.C.
141–149, 321–394, 467f, 679, 821, 1034; 28 in the Federal Register is addressed in
mstockstill on DSK4VPTVN1PROD with RULES

statute’ ’’).
5 See, e.g,. Am. Express Co. v. Italian Colors Rest., U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. the Postal Accountability and
133 S. Ct. 2304 (2013), AT&T Mobility LLC v. Enhancement Act (PAEA) of 2006.
Concepcion, 131 S. Ct. 1740 (2011). Dated: July 15, 2015. Authorization. The Commission
6 See Davis, 305 F.3d at 1280 (‘‘[T]he FTC’s Leslie Kux, process for periodic publication of
interpretation of the MMWA is unreasonable, and Associate Commissioner for Policy.
we decline to defer to the FTC regulations of the
updates was established in Docket Nos.
MMWA regarding binding arbitration in written [FR Doc. 2015–17714 Filed 7–17–15; 8:45 am] MC2010–21 and CP2010–36, Order No.
warranties.’’). BILLING CODE 4164–01–P 445, April 22, 2010, at 8.

VerDate Sep<11>2014 16:02 Jul 17, 2015 Jkt 235001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\20JYR1.SGM 20JYR1

Document Created: 2015-12-15 12:58:28
Document Modified: 2015-12-15 12:58:28

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; technical amendment.
Dates		This rule is effective July 20, 2015.
Contact		Mary E. Kennelly, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4338, Silver Spring, MD 20993-0002, 240-402-9577, [email protected]
FR Citation		80 FR 42723

80 FR 42723 - Regulatory Hearing Before the Food and Drug Administration; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 138 (July 20, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration