82 FR 58553 - Advisory Committee; Food Advisory Committee; Termination
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 238 (December 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 238 (December 13, 2017)
| Page Range | 58553-58554 | |
| FR Document | 2017-26829 |
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)] [Rules and Regulations] [Pages 58553-58554] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26829] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No. FDA-2017-N-6379] Advisory Committee; Food Advisory Committee; Termination AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the termination of the Food Advisory Committee. This document removes the Food Advisory Committee from the Agency's list of standing advisory committees. DATES: This rule is effective December 13, 2017. FOR FURTHER INFORMATION CONTACT: Karen Strambler, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration, 5001 Campus Dr., Rm. 1C-008, College Park, MD 20740, 240-402-2589, Fax: 301-436-2637, [email protected]. SUPPLEMENTARY INFORMATION: The Food Advisory Committee (the Committee) was established on March 6, 1992 (57 FR 8064). The Committee provides advice to the Commissioner of Food and [[Page 58554]] Drugs and other appropriate officials on emerging food and cosmetic safety, food science, nutrition, and other food-related health issues that FDA considers of primary importance for its food and cosmetics programs. The Committee may also be asked to provide advice and make recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues. The Committee is no longer needed and will be terminated on December 12, 2017. Over the past several years, the Committee has met very infrequently, and the effort and expense of maintaining the Committee are no longer justified. Any relevant food issues in the future could be addressed by FDA's Science Board and/or FDA's Risk Communication Advisory Committee, with additional augmentation of expertise by appropriate subject matter experts serving as temporary members on either of those committees. In addition, CFSAN will continue to hold workshops, meetings, conferences, and webinars to engage with its stakeholders. Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the Agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule. Notice and public comment and a delayed effective date are unnecessary because the Committee is not being adequately used, and the final rule merely removes the name of the Food Advisory Committee from the list of standing advisory committees in Sec. 14.100 (21 CFR 14.100). Therefore, the Agency is amending Sec. 14.100(f) as set forth in the regulatory text of the document. List of Subjects in 21 CFR Part 14 Administrative practice and procedure, Advisory committee, Color additives, Drugs, Radiation protection. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows: PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 0 1. The authority citation for part 14 continues to read as follows: Authority: 5 U.S.C. App. 2; 15 U.S.C 1451-1461, 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub. L. 113- 54. Sec. 14.100 [Amended] 0 2. Section 14.100 is amended by removing paragraph (f). Dated: December 7, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26829 Filed 12-12-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations 58553
any report containing information 10 percent of the voting interest; AND for, its fiscal year that ended in calendar
which is determined to be necessary to (3) if the foreign parent owns the private year 2017.
carry out the surveys and studies fund indirectly (through one or more (4) BE–12 Claim for Not Filing will be
provided for by the Act; and other U.S. business enterprises), there provided for response by persons that
(c) Persons not notified in writing of are no U.S. ‘‘operating companies’’ are not subject to the reporting
their filing obligation by the Bureau of between the foreign parent and the requirements of the BE–12 survey but
Economic Analysis are not required to indirectly-owned private fund. have been contacted by BEA concerning
complete the survey. (c) Forms to be filed. (1) Form BE–12A their reporting status.
■ 3. Add § 801.10 to read as follows: must be completed by a U.S. affiliate (d) Aggregation of real estate
that was majority-owned by one or more investments. All real estate investments
§ 801.10 Rules and regulations for BE–12, of a foreign person must be aggregated
Benchmark Survey of Foreign Direct
foreign parents (for purposes of this
survey, a ‘‘majority-owned’’ U.S. for the purpose of applying the
Investment in the United States—2017.
affiliate is one in which the combined reporting criteria. A single report form
A BE–12, Benchmark Survey of must be filed to report the aggregate
Foreign Direct Investment in the United direct and indirect ownership interest of
all foreign parents of the U.S. affiliate holdings, unless written permission has
States, will be conducted covering 2017. been received from BEA to do
All legal authorities, provisions, exceeds 50 percent) if, on a fully
consolidated basis, or, in the case of real otherwise. Those holdings not
definitions, and requirements contained aggregated must be reported separately
in §§ 801.1 through 801.2 and §§ 801.4 estate investment, on an aggregated
basis, any one of the following three on the same type of report that would
through 801.6 are applicable to this have been required if the real estate
survey. Specific additional rules and items for the U.S. affiliate (not just the
foreign parent’s share) was greater than holdings were aggregated.
regulations for the BE–12 survey are (e) Due date. A fully completed and
given in paragraphs (a) through (e) of $300 million (positive or negative) at the
end of, or for, its fiscal year that ended certified Form BE–12A, BE–12B, BE–
this section. More detailed instructions 12C, or BE–12 Claim for Not Filing is
are given on the report forms and in calendar year 2017:
(i) Total assets (do not net out due to be filed with BEA not later than
instructions. May 31, 2018 (or by June 30, 2018 for
(a) Response required. A response is liabilities);
(ii) Sales or gross operating revenues, reporting companies that use BEA’s
required from persons subject to the
excluding sales taxes; or eFile system).
reporting requirements of the BE–12,
Benchmark Survey of Foreign Direct (iii) Net income after provision for [FR Doc. 2017–26887 Filed 12–12–17; 8:45 am]
Investment in the United States—2017, U.S. income taxes. BILLING CODE 3510–06–P
contained in this section, whether or not (2) Form BE–12B must be completed
they are contacted by BEA. Also, a by:
person, or their agent, contacted by BEA (i) A majority-owned U.S. affiliate if, DEPARTMENT OF HEALTH AND
about reporting in this survey, either by on a fully consolidated basis, or, in the HUMAN SERVICES
sending them a report form or a written case of real estate investment, on an
inquiry, must respond in writing aggregated basis, any one of the three Food and Drug Administration
pursuant to this section. This may be items listed in paragraph (c)(1) of this
accomplished by filing a properly section (not just the foreign parent’s 21 CFR Part 14
completed BE–12 report (BE–12A, BE– share), was greater than $60 million [Docket No. FDA–2017–N–6379]
12B, BE–12C, or BE–12 Claim for Not (positive or negative) but none of these
Filing); items was greater than $300 million Advisory Committee; Food Advisory
(b) Who must report. A BE–12 report (positive or negative) at the end of, or Committee; Termination
is required for each U.S. affiliate (except for, its fiscal year that ended in calendar
certain private funds as described year 2017. AGENCY: Food and Drug Administration,
below), that is, for each U.S. business (ii) A minority-owned U.S. affiliate HHS.
enterprise in which a foreign person (for purposes of this survey, a ACTION: Final rule.
(foreign parent) owned or controlled, ‘‘minority-owned’’ U.S. affiliate is one SUMMARY: The Food and Drug
directly or indirectly, 10 percent or in which the combined direct and Administration (FDA) is announcing the
more of the voting securities in an indirect ownership interest of all foreign termination of the Food Advisory
incorporated U.S. business enterprise, parents of the U.S. affiliate is 50 percent Committee. This document removes the
or an equivalent interest in an or less) if, on a fully consolidated basis, Food Advisory Committee from the
unincorporated U.S. business or, in the case of real estate investment, Agency’s list of standing advisory
enterprise, at the end of the business on an aggregated basis, any one of the committees.
enterprise’s fiscal year that ended in three items listed in paragraph (c)(1) of
calendar year 2017. Certain private this section (not just the foreign parent’s DATES: This rule is effective December
funds are exempt from reporting on the share), was greater than $60 million 13, 2017.
BE–12 survey. If a U.S. business meets (positive or negative) at the end of, or FOR FURTHER INFORMATION CONTACT:
ALL of the following 3 criteria, it is not for, its fiscal year that ended in calendar Karen Strambler, Center for Food Safety
required to file any BE–12 report except year 2017. and Applied Nutrition (CFSAN), Food
to indicate exemption from the survey if (3) Form BE–12C must be completed and Drug Administration, 5001 Campus
contacted by BEA: (1) The U.S. business by a U.S. affiliate if, on a fully Dr., Rm. 1C–008, College Park, MD
sradovich on DSK3GMQ082PROD with RULES
enterprise is a private fund; (2) the consolidated basis, or, in the case of real 20740, 240–402–2589, Fax: 301–436–
private fund does not own, directly or estate investment, on an aggregated 2637, karen.strambler@fda.hhs.gov.
indirectly through another business basis, none of the three items listed in SUPPLEMENTARY INFORMATION: The Food
enterprise, an ‘‘operating company’’— paragraph (c)(1) of this section for a U.S. Advisory Committee (the Committee)
i.e., a business enterprise that is not a affiliate (not just the foreign parent’s was established on March 6, 1992 (57
private fund or a holding company—in share), was greater than $60 million FR 8064). The Committee provides
which the foreign parent owns at least (positive or negative) at the end of, or advice to the Commissioner of Food and
VerDate Sep<11>2014 15:49 Dec 12, 2017 Jkt 244001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\13DER1.SGM 13DER1](https://thefederalregister.org/doc/82_FR_58791/page/1.svg)
![58554 Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
Drugs and other appropriate officials on Therefore, under the Federal Food, of the availability of summaries of the
emerging food and cosmetic safety, food Drug, and Cosmetic Act and under basis of approval and of environmental
science, nutrition, and other food- authority delegated to the Commissioner review documents, where applicable.
related health issues that FDA considers of Food and Drugs, 21 CFR part 14 is The animal drug regulations are also
of primary importance for its food and amended as follows: being amended to make technical
cosmetics programs. The Committee amendments to improve the accuracy of
may also be asked to provide advice and PART 14—PUBLIC HEARING BEFORE the regulations.
make recommendations on ways of A PUBLIC ADVISORY COMMITTEE
DATES: This rule is effective December
communicating to the public the
■ 1. The authority citation for part 14 13, 2017.
potential risks associated with these
issues and on approaches that might be continues to read as follows: FOR FURTHER INFORMATION CONTACT:
considered for addressing the issues. Authority: 5 U.S.C. App. 2; 15 U.S.C 1451– George K. Haibel, Center for Veterinary
The Committee is no longer needed 1461, 21 U.S.C. 41–50, 141–149, 321–394, Medicine (HFV–6), Food and Drug
and will be terminated on December 12, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 Administration, 7500 Standish Pl.,
2017. Over the past several years, the U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; Rockville, MD 20855, 240–402–5689,
Committee has met very infrequently, Pub. L. 108–155; Pub. L. 113–54. george.haibel@fda.hhs.gov.
and the effort and expense of § 14.100 [Amended] SUPPLEMENTARY INFORMATION:
maintaining the Committee are no
longer justified. Any relevant food ■ 2. Section 14.100 is amended by I. Approval Actions
issues in the future could be addressed removing paragraph (f).
Dated: December 7, 2017.
FDA is amending the animal drug
by FDA’s Science Board and/or FDA’s
regulations to reflect approval actions
Risk Communication Advisory Leslie Kux,
for a NADA and ANADAs during May
Committee, with additional Associate Commissioner for Policy. and June 2017, as listed in table 1. In
augmentation of expertise by [FR Doc. 2017–26829 Filed 12–12–17; 8:45 am] addition, FDA is informing the public of
appropriate subject matter experts BILLING CODE 4164–01–P the availability, where applicable, of
serving as temporary members on either
of those committees. In addition, documentation of environmental review
CFSAN will continue to hold required under the National
DEPARTMENT OF HEALTH AND Environmental Policy Act (NEPA) and,
workshops, meetings, conferences, and HUMAN SERVICES
webinars to engage with its for actions requiring review of safety or
stakeholders. effectiveness data, summaries of the
Food and Drug Administration
Under 5 U.S.C. 553(b)(3)(B) and (d) basis of approval (FOI Summaries)
and 21 CFR 10.40(d) and (e), the Agency under the Freedom of Information Act
21 CFR Parts 510, 520, 522, 524, 529,
finds good cause to dispense with notice (FOIA). These public documents may be
and 558
and public comment procedures and to seen in the Dockets Management Staff
proceed to an immediate effective date [Docket No. FDA–2017–N–0002] (HFA–305), Food and Drug
on this rule. Notice and public comment Administration, 5630 Fishers Lane, Rm.
New Animal Drugs; Approval of New 1061, Rockville, MD 20852, between 9
and a delayed effective date are Animal Drug Applications
unnecessary because the Committee is a.m. and 4 p.m., Monday through
not being adequately used, and the final AGENCY: Food and Drug Administration, Friday. Persons with access to the
rule merely removes the name of the HHS. internet may obtain these documents at
Food Advisory Committee from the list Final rule; technical
ACTION: the CVM FOIA Electronic Reading
of standing advisory committees in amendments. Room: https://www.fda.gov/AboutFDA/
§ 14.100 (21 CFR 14.100). CentersOffices/OfficeofFoods/CVM/
Therefore, the Agency is amending SUMMARY: The Food and Drug CVMFOIAElectronicReadingRoom/
§ 14.100(f) as set forth in the regulatory Administration (FDA or we) is default.htm. Marketing exclusivity and
text of the document. amending the animal drug regulations to patent information may be accessed in
reflect application-related actions for a FDA’s publication, Approved Animal
List of Subjects in 21 CFR Part 14 new animal drug application (NADA) Drug Products Online (Green Book) at:
Administrative practice and and abbreviated new animal drug https://www.fda.gov/AnimalVeterinary/
procedure, Advisory committee, Color applications (ANADAs) during May and Products/ApprovedAnimalDrug
additives, Drugs, Radiation protection. June 2017. FDA is informing the public Products/default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2017
Public
Approval date File No. Sponsor Product name Species Effect of the action documents
May 23, 2017 ............ 055–099 Zoetis Inc., 333 Portage CLAVAMOX (amoxicillin Dogs and cats ...... Supplemental approval of FOI Summary.
St., Kalamazoo, MI and clavulanate potas- a chewable tablet form
49007. sium tablets) Chewables. of the approved tablet.
June 21, 2017 ........... 141–338 Elanco US Inc., 2500 In- INTERCEPTOR SPEC- Dogs ..................... Supplemental approval for FOI Summary.
novation Way, Green- TRUM (milbemycin the treatment and con-
field, IN 46140. oxime/ praziquantel) trol of adult tapeworm
sradovich on DSK3GMQ082PROD with RULES
Chewable Tablets. (Dipylidium caninum) in-
fections in dogs and
puppies 2 pounds of
body weight or greater
and 6 weeks of age and
older.
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Document Created: 2017-12-13 01:24:00
Document Modified: 2017-12-13 01:24:00
| 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. | |
| Dates | This rule is effective December 13, 2017. | |
| Contact | Karen Strambler, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration, 5001 Campus Dr., Rm. 1C-008, College Park, MD 20740, 240-402-2589, Fax: 301-436-2637, [email protected] | |
| FR Citation | 82 FR 58553 | |
| CFR Associated | Administrative Practice and Procedure; Advisory Committee; Color Additives; Drugs and Radiation Protection |
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