81 FR 89848 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 239 (December 13, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 239 (December 13, 2016)
| Page Range | 89848-89849 | |
| FR Document | 2016-29774 |
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)] [Rules and Regulations] [Pages 89848-89849] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29774] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271 [Docket No. FDA-2005-N-0464 (Formerly Docket No. 2005N-0403)] Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule entitled ``Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs'' that appeared in the Federal Register of August 31, 2016 (81 FR 60169). That final rule amended current regulations [[Page 89849]] concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule was published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. This document corrects that error. DATES: Effective December 13, 2016. FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-2242. SUPPLEMENTARY INFORMATION: In the Federal Register of August 31, 2016 (81 FR 60169), FDA published the final rule ``Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs.'' The final rule published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. Under the amended regulations, manufacturers, repackers, relabelers, or salvagers who manufacture, repack, relabel, or salvage drugs solely for use in research, teaching, or chemical analysis and not for sale are exempt from the establishment registration requirement under 21 CFR 207.13(e) if they do not engage in other activities that require them to register. In the Federal Register of August 31, 2016, in FR Doc. 2016-20471, the following correction is made: On page 60185, in the first column, in the third paragraph under ``2. When must initial registration information be provided? (Sec. 207.21),'' the following sentence is removed: ``Accordingly, an establishment at which an investigational drug is manufactured is subject to the establishment registration requirement.'' Dated: December 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29774 Filed 12-12-16; 8:45 am] BILLING CODE 4164-01-P
![89848 Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Rules and Regulations
(d) Limits. The General Counsel will specifically authorized to do so by the petitions for reconsideration are within
limit any authorization for testimony to General Counsel, the employee must the discretion of the United States Trade
the scope of the demand, and the scope not: Representative or his/her designee, and
of permissible production of records (1) Disclose classified, confidential or are final.
and information to that set forth in the privileged information; or (c) Pursuant to section 704 of the
written authorization. (2) For a current USTR employee, Administrative Procedure Act, 5 U.S.C.
(e) Failure to meet requirements and testify as an expert or opinion witness 704, a petition for reconsideration of a
exceptions. USTR may oppose any with regard to any matter arising out of final determination under this section is
demand or request that does not meet the employee’s official duties or USTR’s a prerequisite to judicial review.
the requirements set forth in this mission or functions, unless testimony
§ 2004.39 Fees.
subpart. The General Counsel may grant is provided on behalf of the United
exceptions to the requirements in this States. A former employee can provide (a) USTR may condition the
subpart upon a showing of compelling expert or opinion testimony where the production of records, information or an
need, to promote a significant interest of testimony involves only general employee’s appearance on advance
USTR or the United States, or for other expertise gained while employed as a payment of reasonable costs, which may
USTR employee. include but are not limited to those
good cause.
associated with employee search time,
§ 2004.35 Processing demands and § 2004.37 Restrictions that apply to copying, computer usage, and
requests. released records and information. certifications.
(a) The General Counsel will review a (a) The General Counsel may impose (b) Witness fees will include fees,
request or demand to produce or conditions or restrictions on the release expenses and allowances prescribed by
disclose records, information or of records and information, including the rules applicable to the particular
testimony and determine whether, or requiring the parties to the legal legal proceeding. If no fees are
under what conditions, to authorize the proceeding to obtain a protective order prescribed, USTR will base fees on the
employee to testify regarding USTR or to execute a confidentiality rule of the federal district court closest
matters or produce records and agreement to limit access and further to the location where the witness will
information. The General Counsel will disclosure. The terms of a protective appear. Such fees may include but are
notify the requester of the final order or confidentiality agreement must not limited to time for preparation,
determination, the reasons for the grant be acceptable to the General Counsel. In travel and attendance at the legal
or denial of the demand or request, and cases where protective orders or proceeding.
any conditions on disclosure. confidentiality agreements already have Janice Kaye,
(b) When necessary, the General been executed, USTR may condition the Chief Counsel for Administrative Law, Office
Counsel will coordinate with the U.S. release of records and information on an of the U.S. Trade Representative.
Department of Justice to file appropriate amendment to the existing protective [FR Doc. 2016–29875 Filed 12–12–16; 8:45 am]
motions, including motions to remove order or confidentiality agreement.
BILLING CODE 3290–F7–P
the matter to Federal court, to quash, or (b) If the General Counsel so
to obtain a protective order. determines, USTR may present original
(c) The General Counsel will process records for examination in response to
a demand or request, but the records DEPARTMENT OF HEALTH AND
demands and requests in the order in
cannot be marked or altered or HUMAN SERVICES
which they are received. Absent
unusual circumstances and depending presented as evidence or otherwise used Food and Drug Administration
on the scope of the demand or request, in a manner by which they could lose
the General Counsel will respond their status as original records. In lieu 21 CFR Parts 20, 201, 207, 314, 514,
within 45 calendar days of the date of original records, certified copies will 515, 601, 607, and 1271
USTR receives all information necessary be presented for evidentiary purposes.
to evaluate the demand or request. (See 28 U.S.C. 1733). [Docket No. FDA–2005–N–0464 (Formerly
Docket No. 2005N–0403)]
§ 2004.36 Restrictions that apply to § 2004.38 In the event of an adverse ruling.
testimony. (a) Notwithstanding USTR’s rejection Requirements for Foreign and
(a) The General Counsel may impose of a demand or request for records, Domestic Establishment Registration
conditions or restrictions on the information or testimony, if a court or and Listing for Human Drugs,
testimony of USTR employees other competent authority orders a Including Drugs That Are Regulated
including, for example, limiting the USTR employee to comply with the Under a Biologics License Application,
scope of testimony or requiring the demand, the employee promptly must and Animal Drugs; Correction
requester and other parties to the legal notify the General Counsel of the order, AGENCY: Food and Drug Administration,
proceeding to agree that the testimony and must respectfully decline to HHS.
transcript will be kept under seal or will comply, citing United States ex rel. ACTION: Final rule; correction.
only be used or made available in the Touhy v. Ragen, 340 U.S. 462 (1951).
particular legal proceeding for which (b) To seek reconsideration of USTR’s SUMMARY: The Food and Drug
testimony was requested. The General rejection of a demand or request, or of Administration (FDA) is correcting a
Counsel also may require a copy of the any restrictions on receiving records, final rule entitled ‘‘Requirements for
testimony transcript at the requester’s information or testimony, a requester Foreign and Domestic Establishment
pmangrum on DSK3GDR082PROD with RULES
expense. must send a petition for reconsideration Registration and Listing for Human
(b) USTR may offer the employee’s in accordance with § 2004.34(a) within Drugs, Including Drugs That Are
written declaration in lieu of testimony. 10 days of the date of the determination. Regulated Under a Biologics License
(c) If authorized to testify pursuant to The petition must contain a clear and Application, and Animal Drugs’’ that
this subpart, an employee may testify as concise statement of the basis for the appeared in the Federal Register of
to relevant facts within his or her reconsideration with supporting August 31, 2016 (81 FR 60169). That
personal knowledge, but, unless authorities. Determinations about final rule amended current regulations
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![Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Rules and Regulations 89849
concerning who must register DEPARTMENT OF THE TREASURY number assigned by the Office of
establishments and list human drugs, Management and Budget.
human drugs that are also biological Internal Revenue Service Books or records relating to a
products, and animal drugs. The final collection of information must be
rule was published with an incorrect 26 CFR Parts 1 and 301 retained as long as their contents may
statement in the preamble about the become material in the administration
[TD 9796] of any internal revenue law. Generally,
rule’s effect on establishments at which
investigational drugs are manufactured. tax returns and tax return information
RIN 1545–BM94
are confidential, as required by 26
This document corrects that error.
Treatment of Certain Domestic Entities U.S.C. 6103.
DATES: Effective December 13, 2016. Disregarded as Separate From Their Background and Explanation of
FOR FURTHER INFORMATION CONTACT: Owners as Corporations for Purposes Provisions
David Joy, Center for Drug Evaluation of Section 6038A
On May 10, 2016, the Department of
and Research, Food and Drug AGENCY: Internal Revenue Service (IRS), the Treasury (Treasury Department) and
Administration, 10903 New Hampshire Treasury. the Internal Revenue Service (IRS)
Ave., Bldg. 51, Rm. 6254, Silver Spring, ACTION: Final regulations.
published in the Federal Register a
MD 20993–0002, 301–796–2242. notice of proposed rulemaking (REG–
SUMMARY: This document contains final 127199–15; 81 FR 28784) under sections
SUPPLEMENTARY INFORMATION: In the
regulations that treat a domestic 6038A and 7701 (the proposed
Federal Register of August 31, 2016 (81 regulations). The proposed regulations
disregarded entity wholly owned by a
FR 60169), FDA published the final rule would treat a domestic disregarded
foreign person as a domestic corporation
‘‘Requirements for Foreign and entity wholly owned by a foreign person
separate from its owner for the limited
Domestic Establishment Registration as a domestic corporation separate from
purposes of the reporting, record
and Listing for Human Drugs, Including maintenance and associated compliance its owner for the limited purposes of the
Drugs That Are Regulated Under a requirements that apply to 25 percent reporting, record maintenance and
Biologics License Application, and foreign-owned domestic corporations associated compliance requirements
Animal Drugs.’’ The final rule published under section 6038A of the Internal that apply to 25 percent foreign-owned
with an incorrect statement in the Revenue Code. domestic corporations under section
preamble about the rule’s effect on DATES: Effective date: These regulations
6038A of the Internal Revenue Code.
establishments at which investigational are effective December 13, 2016. The proposed regulations would have
drugs are manufactured. Under the applied to taxable years of the entities
Applicability date: For dates of
amended regulations, manufacturers, described in § 301.7701–2(c)(2)(vi)
applicability, see §§ 1.6038A–1(n)(1)
repackers, relabelers, or salvagers who ending on or after the date that is 12
and (2) and 301.7701–2(e)(9).
manufacture, repack, relabel, or salvage months after the date of publication of
FOR FURTHER INFORMATION CONTACT: the Treasury decision adopting the
drugs solely for use in research, Ronald M. Gootzeit, (202) 317–6937 (not
teaching, or chemical analysis and not proposed rules as final regulations in
a toll-free number). the Federal Register.
for sale are exempt from the
SUPPLEMENTARY INFORMATION: In addition to generally soliciting
establishment registration requirement
Paperwork Reduction Act comments on all aspects of the proposed
under 21 CFR 207.13(e) if they do not
rules, the preamble to the proposed
engage in other activities that require The collection of information regulations specifically requested
them to register. contained in these final regulations has comments on possible alternative
In the Federal Register of August 31, been previously reviewed and approved methods for reporting a domestic
2016, in FR Doc. 2016–20471, the by the Office of Management and disregarded entity’s transactions in
following correction is made: On page Budget in accordance with the cases in which the foreign owner of the
60185, in the first column, in the third Paperwork Reduction Act of 1995 (44 domestic disregarded entity already has
paragraph under ‘‘2. When must initial U.S.C. 3507(d)) under control number an obligation to report the income
registration information be provided? 1545–1191. The estimated average resulting from those transactions—for
(§ 207.21),’’ the following sentence is annual recordkeeping burden per example, transactions resulting in
removed: ‘‘Accordingly, an recordkeeper is 10 hours. The estimated income effectively connected with the
establishment at which an reporting burden is being reported conduct of a U.S. trade or business.
under Form 5472 (OMB #1545–0123). No written comments on the proposed
investigational drug is manufactured is
The collection of information in these regulations were received, and no
subject to the establishment registration
final regulations is in §§ 1.6038A–2 and public hearing was requested or held.
requirement.’’
1.6038A–3. This information will However, these final regulations reflect
Dated: December 7, 2016. enhance the United States’ compliance a limited number of changes by the
Leslie Kux, with international standards of Treasury Department and the IRS to the
Associate Commissioner for Policy. transparency and exchange of proposed regulations.
[FR Doc. 2016–29774 Filed 12–12–16; 8:45 am]
information for tax purposes and will First, it was and remains the intent of
strengthen the enforcement of U.S. tax the Treasury Department and the IRS
BILLING CODE 4164–01–P
laws. The likely respondents are that the generally applicable exceptions
pmangrum on DSK3GDR082PROD with RULES
foreign-owned domestic entities that are to the requirements of section 6038A
disregarded as separate from their should not apply to a domestic
owners. disregarded entity that is wholly owned
An agency may not conduct or by a foreign person. Accordingly, the
sponsor, and a person is not required to proposed regulations provided that the
respond to, a collection of information exceptions to the record maintenance
unless it displays a valid control requirements in § 1.6038A–1(h) and (i)
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Document Created: 2016-12-13 02:43:58
Document Modified: 2016-12-13 02:43:58
| 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; correction. | |
| Dates | Effective December 13, 2016. | |
| Contact | David Joy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-2242. | |
| FR Citation | 81 FR 89848 | |
| CFR Citation | 21
CFR
1271 21 CFR 20 21 CFR 201 21 CFR 207 21 CFR 314 21 CFR 514 21 CFR 515 21 CFR 601 21 CFR 607 |
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