Office of Regulatory Affairs Division Director; Technical Amendments, 50780-50783 [2020-17037]
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50780
Federal Register / Vol. 85, No. 160 / Tuesday, August 18, 2020 / Rules and Regulations
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
2. Section 71.1 is revised to read as
follows:
■
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A listing for Class A, B, C, D, and E
airspace areas; air traffic service routes;
and reporting points can be found in
FAA Order 7400.11E, Airspace
Designations and Reporting Points,
dated July 21, 2020. This incorporation
by reference was approved by the
Director of the Federal Register in
accordance with 5 U.S.C. 552 (a) and 1
CFR part 51. The approval to
incorporate by reference FAA Order
7400.11E is effective September 15,
2020, through September 15, 2021.
During the incorporation by reference
period, proposed changes to the listings
of Class A, B, C, D, and E airspace areas;
air traffic service routes; and reporting
points will be published in full text as
proposed rule documents in the Federal
Register. Amendments to the listings of
Class A, B, C, D, and E airspace areas;
air traffic service routes; and reporting
points will be published in full text as
final rules in the Federal Register.
Periodically, the final rule amendments
will be integrated into a revised edition
of the Order and submitted to the
Director of the Federal Register for
approval for incorporation by reference
in this section. Copies of FAA Order
7400.11E may be obtained from
Airspace Policy Group, Federal Aviation
Administration, 800 Independence
Avenue SW, Washington, DC 20591,
(202) 267–8783. An electronic version of
the Order is available on the FAA
website at https://www.faa.gov/air_
traffic/publications. Copies of FAA
Order 7400.11E may be inspected in
Docket No. FAA–2020–0702;
Amendment No. 71–52, on https://
www.regulations.gov. A copy of FAA
Order 7400.11E may be inspected at the
National Archives and Records
Administration (NARA). For
information on the availability of FAA
Order 7400.11E at NARA, email:
fedreg.legal@nara.gov or go to https://
17:17 Aug 17, 2020
Jkt 250001
§ 71.5
Food and Drug Administration
[Amended]
3. Section 71.5 is amended by
removing the words ‘‘FAA Order
7400.11D’’ and adding, in their place,
the words ‘‘FAA Order 7400.11E.’’
■
§ 71.15
4. Section 71.15 is amended by
removing the words ‘‘FAA Order
7400.11D’’ and adding, in their place,
the words ‘‘FAA Order 7400.11E.’’
§ 71.31
[Amended]
6. Paragraph (c) of section 71.33 is
amended by removing the words ‘‘FAA
Order 7400.11D’’ and adding, in their
place, the words ‘‘FAA Order
7400.11E.’’
■
§ 71.41
[Amended]
7. Section 71.41 is amended by
removing the words ‘‘FAA Order
7400.11D’’ and adding, in their place,
the words ‘‘FAA Order 7400.11E.’’
■
§ 71.51
[Amended]
8. Section 71.51 is amended by
removing the words ‘‘FAA Order
7400.11D’’ and adding, in their place,
the words ‘‘FAA Order 7400.11E.’’
■
§ 71.61
[Amended]
9. Section 71.61 is amended by
removing the words ‘‘FAA Order
7400.11D’’ and adding, in their place,
the words ‘‘FAA Order 7400.11E.’’
■
§ 71.71
[Amended]
10. Paragraphs (b), (c), (d), (e), and (f)
of section 71.71 are amended by
removing the words ‘‘FAA Order
7400.11D’’ and adding, in their place,
the words ‘‘FAA Order 7400.11E.’’
■
§ 71.901
[Amended]
11. Paragraph (a) of section 71.901 is
amended by removing the words ‘‘FAA
Order 7400.11D’’ and adding, in their
place, the words ‘‘FAA Order
7400.11E.’’
■
Issued in Washington, DC, on August 13,
2020.
Scott M. Rosenbloom,
Acting Manager, Airspace and Regulations
Group.
[FR Doc. 2020–18048 Filed 8–17–20; 8:45 am]
BILLING CODE 4910–13–P
PO 00000
[Docket No. FDA–2019–N–0011]
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
[Amended]
5. Section 71.31 is amended by
removing the words ‘‘FAA Order
7400.11D’’ and adding, in their place,
the words ‘‘FAA Order 7400.11E.’’
§ 71.33
21 CFR Parts 1 and 1005
Office of Regulatory Affairs Division
Director; Technical Amendments
[Amended]
■
Applicability.
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
■
1. The authority citation for part 71
continues to read as follows:
■
§ 71.1
www.archives.gov/federal-register/cfr/
ibr-locations.html.
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The Food and Drug
Administration (FDA, the Agency, or
we) is revising its regulations to reflect
changes to the Agency’s organizational
structure, including the reorganization
of the Office of Regulatory Affairs
(ORA). The revisions update addresses
and replace references to the district
officials with references to division
officials. The rule does not impose any
new regulatory requirements on affected
parties. This action is editorial in nature
and is intended to improve the accuracy
of the Agency’s regulations.
DATES: This rule is effective August 18,
2020.
FOR FURTHER INFORMATION CONTACT:
Holli Kubicki, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20852, 240–402–4557.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
ORA has reorganized to align field
activities by FDA-regulated commodity
(e.g., food, drugs, medical devices) or
program area (e.g., imports). As a result,
ORA division officials now perform
certain duties such as those related to
administrative appeals and informal
hearings previously performed by
district officials. FDA regulations
included numerous references to district
officials. The revisions made by this
rule update these references to division
officials, but do not alter any
substantive standards.
II. Description of the Technical
Amendments
The regulations specified in this rule
have been revised to replace references
to the ORA Official, including ‘‘District
Director’’ with references to the ORA
division official, including ‘‘Division
Director,’’ to reflect the ORA program
alignment. In addition, we have updated
the references to U.S. Customs and
Border Protection, updated several
addresses, and have made minor
conforming amendments and
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Federal Register / Vol. 85, No. 160 / Tuesday, August 18, 2020 / Rules and Regulations
grammatical changes as necessary to
accommodate the new terminology.
Finally, we have modified the hourly
cost calculations related to overseeing
reconditioning of imported products to
bring them into compliance with the
Federal Food, Drug, and Cosmetic Act to
reflect 10 legal public holidays.
We are making these technical
amendments to revise descriptions of
FDA officials designated to perform
certain functions. The amendments are
technical and editorial in nature and
should not be construed as modifying
any substantive standards.
III. Notice and Public Comment
Publication of this document
constitutes final action of these changes
under the Administrative Procedure Act
(APA) (5 U.S.C. 553). Section 553 of the
APA exempts ‘‘rules of agency
organization, procedure, or practice’’
from proposed rulemaking (i.e., notice
and comment rulemaking). 5 U.S.C.
553(b)(3)(A). Rules are also exempt
when an agency finds ‘‘good cause’’ that
notice and comment rulemaking
procedures would be ‘‘impracticable,
unnecessary, or contrary to the public
interest.’’ 5 U.S.C. 553(b)(3)(B).
FDA has determined that this
rulemaking meets the notice and
comment exemption requirements in 5
U.S.C. 553(b)(3)(A) and (B). FDA’s
revisions make technical or nonsubstantive changes that pertain solely
to the designation of FDA officials, and
do not alter any substantive standard.
FDA does not believe public comment
is necessary for these minor revisions.
The APA allows an effective date less
than 30 days after publication as
‘‘provided by the agency for good cause
found and published with the rule’’ (5
U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because
the amendments do not impose any new
regulatory requirements on affected
parties. As a result, affected parties do
not need time to prepare before the rule
takes effect. Therefore, FDA finds good
cause for the amendments to become
effective on the date of publication of
this action.
List of Subjects
21 CFR Part 1
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Cosmetics, Drugs, Exports, Food
labeling, Imports, Labeling, Reporting
and recordkeeping requirements.
Administrative practice and
procedure, Electronic products, Imports,
Radiation protection, Surety bonds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
17:17 Aug 17, 2020
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PART 1—GENERAL ENFORCEMENT
REGULATIONS
1. The authority citation for part 1
continues to read as follows:
■
Authority: 15 U.S.C. 1333, 1453, 1454,
1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C.
321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b,
360ccc, 360ccc–1, 360ccc–2, 362, 371, 373,
374, 379j-31, 381, 382, 384a, 384b, 384d, 387,
387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262,
264, 271; Pub. L. 107–188, 116 Stat. 594,
668–69; Pub. L. 111–353, 124 Stat. 3885,
3889.
2. Amend § 1.83 by revising paragraph
(b) to read as follows:
■
§ 1.83
Definitions.
*
*
*
*
*
(b) The term division director means
the director of the division of the Food
and Drug Administration having
jurisdiction over the port of entry
through which an article is imported or
offered for import, or such officer of the
division as he or she may designate to
act on his or her behalf in administering
and enforcing the provisions of section
801(a), (b), and (c).
■ 3. Revise § 1.90 to read as follows:
§ 1.90
Notice of sampling.
When a sample of an article offered
for import has been requested by the
division director, FDA shall provide to
the owner or consignee prompt notice of
delivery of, or intention to deliver, such
sample. Upon receipt of the notice, the
owner or consignee shall hold such
article and not distribute it until further
notice from the division director or U.S.
Customs and Border Protection of the
results of examination of the sample.
■ 4. In § 1.91, revise the second sentence
to read as follows:
§ 1.91
Payment for samples.
* * * Billing for reimbursement
should be made by the owner or
consignee to the Food and Drug
Administration division where the
shipment was offered for import. * * *
■ 5. Amend § 1.94 by revising the first
sentence of paragraph (a), the second
sentence of paragraph (b), and
paragraph (c) to read as follows:
§ 1.94 Hearing on refusal of admission or
destruction.
21 CFR Part 1005
VerDate Sep<11>2014
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 1 and
1005 are amended as follows:
(a) If it appears that the article may be
subject to refusal of admission or that
the article is a drug that may be subject
to destruction under section 801(a) of
the Federal Food, Drug, and Cosmetic
Act, the division director shall give the
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50781
owner or consignee a written or
electronic notice to that effect, stating
the reasons therefor. * * *
(b) * * * If such application is not
submitted at or prior to the hearing on
refusal of admission, the division
director shall specify a time limit,
reasonable in the light of the
circumstances, for filing such
application.
(c) If the article is a drug that may be
subject to destruction under section
801(a) of the Federal Food, Drug, and
Cosmetic Act, the division director may
give the owner or consignee a single
written or electronic notice that
provides the notice of refusal of
admission and the notice of destruction
of an article described in paragraph (a)
of this section. The division director
may also combine the hearing on refusal
of admission with the hearing on
destruction of the article described in
paragraph (a) of this section into a single
proceeding.
■ 6. Amend § 1.95 by revising the
introductory text to read as follows:
§ 1.95 Application for authorization to
relabel and recondition.
Application for authorization to
relabel or perform other action to bring
the article into compliance with the
Federal Food, Drug, and Cosmetic Act
or to render it other than a food, drug,
device, or cosmetic may be filed only by
the owner or consignee, and shall:
*
*
*
*
*
■ 7. Amend § 1.96 by revising paragraph
(a) introductory text and paragraphs
(a)(3), (b), (c), and (d) to read as follows:
§ 1.96 Granting of authorization to relabel
and recondition.
(a) When authorization of a proposal
under § 1.95 is granted by the division
director, the applicant shall be notified
of authorization, in writing, which may
include:
*
*
*
*
*
(3) That the operations are to be
carried out under the supervision of an
officer of the Food and Drug
Administration or U.S. Customs and
Border Protection, as appropriate;
*
*
*
*
*
(b) Upon receipt of a written request
for extension of time to complete such
operations, containing reasonable
grounds therefor, the division director
may grant such additional time as he or
she deems necessary.
(c) An authorization may be amended
upon a showing of reasonable grounds
therefor and the filing of an amended
application for authorization with the
division director.
(d) If ownership of an article covered
by an authorization changes before the
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Federal Register / Vol. 85, No. 160 / Tuesday, August 18, 2020 / Rules and Regulations
operations specified in the authorization
have been completed, the original
owner will be held responsible, unless
the new owner has executed a bond
with U.S. Customs and Border
Protection and obtained a new
authorization from the Food and Drug
Administration division director. Any
authorization granted under this section
shall supersede and nullify any
previously granted authorization with
respect to the article.
■ 8. Revise § 1.97 to read as follows:
§ 1.97
Bonds.
(a) The bond requirements under
section 801(b) of the Federal Food,
Drug, and Cosmetic Act may be satisfied
by the owner or consignee executing, on
the appropriate U.S. Customs and
Border Protection form, a singletransaction or continuous bond,
containing a condition for the redelivery
of the merchandise or any part thereof
upon demand of U.S. Customs and
Border Protection and containing a
provision for the performance of
conditions as may legally be imposed
for the relabeling or other action
necessary to bring the article into
compliance with the act or rendering it
other than a food, drug, device, or
cosmetic, in such manner as is
prescribed for such bond in the customs
regulations in force on the date of
request for authorization. The bond
shall be filed with U.S. Customs and
Border Protection.
(b) U.S. Customs and Border
Protection may cancel the liability for
liquidated damages incurred under the
above-mentioned provisions of such a
bond, if U.S. Customs and Border
Protection receives an application for
relief therefrom, upon the payment of a
lesser amount or upon such other terms
and conditions as shall be deemed
appropriate under the law and in view
of the circumstances, but U.S. Customs
and Border Protection shall not act
under this regulation unless the Food
and Drug Administration division
director is in full agreement with the
action.
■ 9. Amend § 1.99 by revising
paragraphs (b), (c), and (d) to read as
follows:
§ 1.99 Costs chargeable in connection
with relabeling and reconditioning
inadmissible imports.
*
*
*
*
(b) Per diem in lieu of subsistence of
the supervising officer when away from
his or her home station, as provided by
law.
(c) The charge for the services of the
supervising officer, which shall include
administrative support, shall be
computed at a rate per hour equal to 267
percent of the hourly rate of regular pay
of a grade GS–11/4 employee, except
that such services performed by a
customs officer and subject to the
provisions of the act of February 13,
1911, as amended (sec. 5, 36 Stat. 901,
as amended (19 U.S.C. 267)), shall be
calculated as provided in that act.
(d) The charge for the service of the
analyst, which shall include
administrative and laboratory support,
shall be computed at a rate per hour
equal to 267 percent of the hourly rate
of regular pay of a grade GS–12/4
employee. The rate per hour equal to
267 percent of the equivalent hourly
rate of regular pay of the supervising
officer (GS–11/4) and the analyst (GS–
12/4) is computed as follows:
*
TABLE 1 TO PARAGRAPH (d)
Hours
Gross number of working hours in 52 40-hr weeks ........................................................................................................................................
Less:
10 legal public holidays—New Year’s Day, Birthday of Martin Luther King, Jr., Washington’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day .........................................................
Annual leave—26 d ..................................................................................................................................................................................
Sick leave—13 d ......................................................................................................................................................................................
2,080
Total ...................................................................................................................................................................................................
392
Net number of working hours ............................................................................................................................................................
1,688
Gross number of working hours in 52 40-hr weeks ........................................................................................................................................
Working hour equivalent of Government contributions for employee retirement, life insurance, and health benefits computed at 81⁄2 pct.
of annual rate of pay of employee ...............................................................................................................................................................
Equivalent annual working hours .............................................................................................................................................................
Support required to equal to 1 person-year ....................................................................................................................................................
Equivalent gross annual working hours charged to Food and Drug appropriation .................................................................................
2,080
80
208
104
176
2,256
2,256
4,512
Note: Ratio of equivalent gross annual number of working hours charged to Food and Drug appropriation to net number of annual working
hours 4,512/1,688 = 267 pct.
*
*
*
*
*
10. Amend § 1.101 to revise
paragraphs (d)(2)(ii) and (iii) to read as
follows:
■
§ 1.101
Notification and recordkeeping.
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*
*
*
*
*
(d) * * *
(2) * * *
(ii) For human drug products,
biological products, and devices
regulated by the Center for Drug
Evaluation and Research—Office of
Drug Security, Integrity and Response,
VerDate Sep<11>2014
17:17 Aug 17, 2020
Jkt 250001
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002.
(iii) For devices—DRP2: Division of
Establishment Support, Office of
Regulatory Programs, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, 10903
New Hampshire Ave., Bldg. 66, Rm.
1423, Silver Spring, MD 20993.
*
*
*
*
*
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11. Amend § 1.280 by revising the first
sentence of paragraph (c) to read as
follows:
■
§ 1.280
How must you submit prior notice?
*
*
*
*
*
(c) If FDA determines that FDA PNSI
or the Operational and Administration
System for Import Support (OASIS) is
not working, FDA will post prominent
notification and instructions at https://
www.access.fda.gov—see log-in page.
* * *
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Federal Register / Vol. 85, No. 160 / Tuesday, August 18, 2020 / Rules and Regulations
14. Amend § 1005.24 to revise
paragraphs (b) and (c) to read as follows:
■
PART 1005—IMPORTATION OF
ELECTRONIC PRODUCTS
§ 1005.24 Costs of bringing product into
compliance.
12. The authority citation for part
1005 continues to read as follows:
■
*
Authority: 21 U.S.C. 360ii, 360mm.
13. Amend § 1005.11 by revising the
second sentence to read as follows:
■
§ 1005.11
Payment for samples.
* * * Billing for reimbursement
should be made by the owner or
consignee to the Food and Drug
Administration division where the
shipment was offered for import. * * *
*
*
*
*
(b) Per diem in lieu of subsistence of
the supervising officer when away from
his or her home station, as provided by
law;
(c)(1) The charge for the services of
the supervising officer, which shall
include administrative support, shall be
computed at a rate per hour equal to 267
percent of the hourly rate of regular pay
of a grade GS–11/4 employee, except
that such services performed by a
50783
customs officer and subject to the
provisions of the act of February 13,
1911, as amended (section 5, 36 Stat.
901, as amended (19 U.S.C. 267)), shall
be calculated as provided in that act.
(2) The charge for the services of the
analyst, which shall include
administrative and laboratory support,
shall be computed at a rate per hour
equal to 267 percent of the hourly rate
of regular pay of a grade GS–12/4
employee.
(3) The rate per hour equal to 267
percent of the equivalent hourly rate of
regular pay of the supervising officer
(GS–11/4) and the analyst (GS–12/4) is
computed as follows:
TABLE 1 TO PARAGRAPH (c)(3)
Hours
Gross number of working hours in 52 40-hour weeks ....................................................................................................................................
Less:
10 legal public holidays—New Year’s Day, Birthday of Martin Luther King, Jr., Washington’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day .........................................................
Annual Leave—26 days ...........................................................................................................................................................................
Sick Leave—13 days ................................................................................................................................................................................
2,080
Total ...................................................................................................................................................................................................
392
Net number of working hours ............................................................................................................................................................
1,688
Gross number of working hours in 52 40-hour weeks ....................................................................................................................................
Working hour equivalent of Government contributions for employee retirement, life insurance, and health benefits computed at 81⁄2% of
annual rate of pay of employee ...................................................................................................................................................................
Equivalent annual working hours ....................................................................................................................................................................
Support required to equal to 1 person-year ....................................................................................................................................................
Equivalent gross annual working hours charged to Food and Drug appropriation ........................................................................................
2,080
80
208
104
176
2,256
2,256
4,512
Note: Ratio of equivalent gross annual number of working hours charged to Food and Drug appropriation to net number of annual working
hours (4,512/1,688) = 267 pct.
*
*
*
*
*
Dated: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17037 Filed 8–17–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2010–N–0155]
Veterinary Feed Directive Drugs;
Contact Information
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AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to revise a
SUMMARY:
VerDate Sep<11>2014
17:17 Aug 17, 2020
Jkt 250001
current mailing address and to add an
email address to the previously codified
contact information for use by
distributors of an animal feed
containing a veterinary feed directive
(VFD) drug or a combination VFD drug.
This technical amendment is being
made to improve the accuracy and
completeness of the regulations.
DATES: This rule is effective August 18,
2020.
FOR FURTHER INFORMATION CONTACT:
Isabel Pocurull, Center for Veterinary
Medicine (HFV–221), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5877,
isabel.pocurull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations to
revise a current mailing address and to
add an email address to the previously
codified contact information for use by
distributors of an animal feed
containing a VFD drug or a combination
VFD drug.
This final rule sets forth a technical
amendment to the regulations to
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improve the accuracy and completeness
of the regulations, and as such does not
impose any burden on regulated
entities. Although denominated a rule
pursuant to the Federal Food, Drug, and
Cosmetic Act, this document does not
meet the definition of ‘‘rule’’ in 5 U.S.C.
804(3)(A) because it is a ‘‘rule of
particular applicability.’’ Therefore, it is
not subject to the congressional review
requirements in 5 U.S.C. 801–808.
Likewise, this is not a rule subject to
Executive Order 12866, which defines a
rule as ‘‘an agency statement of general
applicability and future effect, which
the agency intends to have the force and
effect of law, that is designed to
implement, interpret, or prescribe law
or policy or to describe the procedure or
practice requirements of an agency.’’
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 558 is
amended as follows:
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]]>Agencies
[Federal Register Volume 85, Number 160 (Tuesday, August 18, 2020)]
[Rules and Regulations]
[Pages 50780-50783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17037]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1 and 1005
[Docket No. FDA-2019-N-0011]
Office of Regulatory Affairs Division Director; Technical
Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
revising its regulations to reflect changes to the Agency's
organizational structure, including the reorganization of the Office of
Regulatory Affairs (ORA). The revisions update addresses and replace
references to the district officials with references to division
officials. The rule does not impose any new regulatory requirements on
affected parties. This action is editorial in nature and is intended to
improve the accuracy of the Agency's regulations.
DATES: This rule is effective August 18, 2020.
FOR FURTHER INFORMATION CONTACT: Holli Kubicki, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20852, 240-402-4557.
SUPPLEMENTARY INFORMATION:
I. Background
ORA has reorganized to align field activities by FDA-regulated
commodity (e.g., food, drugs, medical devices) or program area (e.g.,
imports). As a result, ORA division officials now perform certain
duties such as those related to administrative appeals and informal
hearings previously performed by district officials. FDA regulations
included numerous references to district officials. The revisions made
by this rule update these references to division officials, but do not
alter any substantive standards.
II. Description of the Technical Amendments
The regulations specified in this rule have been revised to replace
references to the ORA Official, including ``District Director'' with
references to the ORA division official, including ``Division
Director,'' to reflect the ORA program alignment. In addition, we have
updated the references to U.S. Customs and Border Protection, updated
several addresses, and have made minor conforming amendments and
[[Page 50781]]
grammatical changes as necessary to accommodate the new terminology.
Finally, we have modified the hourly cost calculations related to
overseeing reconditioning of imported products to bring them into
compliance with the Federal Food, Drug, and Cosmetic Act to reflect 10
legal public holidays.
We are making these technical amendments to revise descriptions of
FDA officials designated to perform certain functions. The amendments
are technical and editorial in nature and should not be construed as
modifying any substantive standards.
III. Notice and Public Comment
Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
Section 553 of the APA exempts ``rules of agency organization,
procedure, or practice'' from proposed rulemaking (i.e., notice and
comment rulemaking). 5 U.S.C. 553(b)(3)(A). Rules are also exempt when
an agency finds ``good cause'' that notice and comment rulemaking
procedures would be ``impracticable, unnecessary, or contrary to the
public interest.'' 5 U.S.C. 553(b)(3)(B).
FDA has determined that this rulemaking meets the notice and
comment exemption requirements in 5 U.S.C. 553(b)(3)(A) and (B). FDA's
revisions make technical or non-substantive changes that pertain solely
to the designation of FDA officials, and do not alter any substantive
standard. FDA does not believe public comment is necessary for these
minor revisions.
The APA allows an effective date less than 30 days after
publication as ``provided by the agency for good cause found and
published with the rule'' (5 U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because the amendments do not impose
any new regulatory requirements on affected parties. As a result,
affected parties do not need time to prepare before the rule takes
effect. Therefore, FDA finds good cause for the amendments to become
effective on the date of publication of this action.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 1005
Administrative practice and procedure, Electronic products,
Imports, Radiation protection, Surety bonds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1 and 1005 are amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
1. The authority citation for part 1 continues to read as follows:
Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a,
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188,
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.
0
2. Amend Sec. 1.83 by revising paragraph (b) to read as follows:
Sec. 1.83 Definitions.
* * * * *
(b) The term division director means the director of the division
of the Food and Drug Administration having jurisdiction over the port
of entry through which an article is imported or offered for import, or
such officer of the division as he or she may designate to act on his
or her behalf in administering and enforcing the provisions of section
801(a), (b), and (c).
0
3. Revise Sec. 1.90 to read as follows:
Sec. 1.90 Notice of sampling.
When a sample of an article offered for import has been requested
by the division director, FDA shall provide to the owner or consignee
prompt notice of delivery of, or intention to deliver, such sample.
Upon receipt of the notice, the owner or consignee shall hold such
article and not distribute it until further notice from the division
director or U.S. Customs and Border Protection of the results of
examination of the sample.
0
4. In Sec. 1.91, revise the second sentence to read as follows:
Sec. 1.91 Payment for samples.
* * * Billing for reimbursement should be made by the owner or
consignee to the Food and Drug Administration division where the
shipment was offered for import. * * *
0
5. Amend Sec. 1.94 by revising the first sentence of paragraph (a),
the second sentence of paragraph (b), and paragraph (c) to read as
follows:
Sec. 1.94 Hearing on refusal of admission or destruction.
(a) If it appears that the article may be subject to refusal of
admission or that the article is a drug that may be subject to
destruction under section 801(a) of the Federal Food, Drug, and
Cosmetic Act, the division director shall give the owner or consignee a
written or electronic notice to that effect, stating the reasons
therefor. * * *
(b) * * * If such application is not submitted at or prior to the
hearing on refusal of admission, the division director shall specify a
time limit, reasonable in the light of the circumstances, for filing
such application.
(c) If the article is a drug that may be subject to destruction
under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the
division director may give the owner or consignee a single written or
electronic notice that provides the notice of refusal of admission and
the notice of destruction of an article described in paragraph (a) of
this section. The division director may also combine the hearing on
refusal of admission with the hearing on destruction of the article
described in paragraph (a) of this section into a single proceeding.
0
6. Amend Sec. 1.95 by revising the introductory text to read as
follows:
Sec. 1.95 Application for authorization to relabel and recondition.
Application for authorization to relabel or perform other action to
bring the article into compliance with the Federal Food, Drug, and
Cosmetic Act or to render it other than a food, drug, device, or
cosmetic may be filed only by the owner or consignee, and shall:
* * * * *
0
7. Amend Sec. 1.96 by revising paragraph (a) introductory text and
paragraphs (a)(3), (b), (c), and (d) to read as follows:
Sec. 1.96 Granting of authorization to relabel and recondition.
(a) When authorization of a proposal under Sec. 1.95 is granted by
the division director, the applicant shall be notified of
authorization, in writing, which may include:
* * * * *
(3) That the operations are to be carried out under the supervision
of an officer of the Food and Drug Administration or U.S. Customs and
Border Protection, as appropriate;
* * * * *
(b) Upon receipt of a written request for extension of time to
complete such operations, containing reasonable grounds therefor, the
division director may grant such additional time as he or she deems
necessary.
(c) An authorization may be amended upon a showing of reasonable
grounds therefor and the filing of an amended application for
authorization with the division director.
(d) If ownership of an article covered by an authorization changes
before the
[[Page 50782]]
operations specified in the authorization have been completed, the
original owner will be held responsible, unless the new owner has
executed a bond with U.S. Customs and Border Protection and obtained a
new authorization from the Food and Drug Administration division
director. Any authorization granted under this section shall supersede
and nullify any previously granted authorization with respect to the
article.
0
8. Revise Sec. 1.97 to read as follows:
Sec. 1.97 Bonds.
(a) The bond requirements under section 801(b) of the Federal Food,
Drug, and Cosmetic Act may be satisfied by the owner or consignee
executing, on the appropriate U.S. Customs and Border Protection form,
a single-transaction or continuous bond, containing a condition for the
redelivery of the merchandise or any part thereof upon demand of U.S.
Customs and Border Protection and containing a provision for the
performance of conditions as may legally be imposed for the relabeling
or other action necessary to bring the article into compliance with the
act or rendering it other than a food, drug, device, or cosmetic, in
such manner as is prescribed for such bond in the customs regulations
in force on the date of request for authorization. The bond shall be
filed with U.S. Customs and Border Protection.
(b) U.S. Customs and Border Protection may cancel the liability for
liquidated damages incurred under the above-mentioned provisions of
such a bond, if U.S. Customs and Border Protection receives an
application for relief therefrom, upon the payment of a lesser amount
or upon such other terms and conditions as shall be deemed appropriate
under the law and in view of the circumstances, but U.S. Customs and
Border Protection shall not act under this regulation unless the Food
and Drug Administration division director is in full agreement with the
action.
0
9. Amend Sec. 1.99 by revising paragraphs (b), (c), and (d) to read as
follows:
Sec. 1.99 Costs chargeable in connection with relabeling and
reconditioning inadmissible imports.
* * * * *
(b) Per diem in lieu of subsistence of the supervising officer when
away from his or her home station, as provided by law.
(c) The charge for the services of the supervising officer, which
shall include administrative support, shall be computed at a rate per
hour equal to 267 percent of the hourly rate of regular pay of a grade
GS-11/4 employee, except that such services performed by a customs
officer and subject to the provisions of the act of February 13, 1911,
as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be
calculated as provided in that act.
(d) The charge for the service of the analyst, which shall include
administrative and laboratory support, shall be computed at a rate per
hour equal to 267 percent of the hourly rate of regular pay of a grade
GS-12/4 employee. The rate per hour equal to 267 percent of the
equivalent hourly rate of regular pay of the supervising officer (GS-
11/4) and the analyst (GS-12/4) is computed as follows:
Table 1 to Paragraph (d)
------------------------------------------------------------------------
Hours
------------------------------------------------------------------------
Gross number of working hours in 52 40-hr weeks................ 2,080
Less:
10 legal public holidays--New Year's Day, Birthday of 80
Martin Luther King, Jr., Washington's Birthday, Memorial
Day, Independence Day, Labor Day, Columbus Day, Veterans
Day, Thanksgiving Day, and Christmas Day..................
Annual leave--26 d......................................... 208
Sick leave--13 d........................................... 104
--------
Total.................................................. 392
--------
Net number of working hours............................ 1,688
------------------------------------------------------------------------
Gross number of working hours in 52 40-hr weeks................ 2,080
Working hour equivalent of Government contributions for 176
employee retirement, life insurance, and health benefits
computed at 8\1/2\ pct. of annual rate of pay of employee.....
Equivalent annual working hours............................ 2,256
Support required to equal to 1 person-year..................... 2,256
Equivalent gross annual working hours charged to Food and 4,512
Drug appropriation........................................
------------------------------------------------------------------------
Note: Ratio of equivalent gross annual number of working hours charged
to Food and Drug appropriation to net number of annual working hours
4,512/1,688 = 267 pct.
* * * * *
0
10. Amend Sec. 1.101 to revise paragraphs (d)(2)(ii) and (iii) to read
as follows:
Sec. 1.101 Notification and recordkeeping.
* * * * *
(d) * * *
(2) * * *
(ii) For human drug products, biological products, and devices
regulated by the Center for Drug Evaluation and Research--Office of
Drug Security, Integrity and Response, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002.
(iii) For devices--DRP2: Division of Establishment Support, Office
of Regulatory Programs, Office of Product Evaluation and Quality,
Center for Devices and Radiological Health, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 1423, Silver Spring, MD 20993.
* * * * *
0
11. Amend Sec. 1.280 by revising the first sentence of paragraph (c)
to read as follows:
Sec. 1.280 How must you submit prior notice?
* * * * *
(c) If FDA determines that FDA PNSI or the Operational and
Administration System for Import Support (OASIS) is not working, FDA
will post prominent notification and instructions at https://
www.access.fda.gov--see log-in page. * * *
[[Page 50783]]
PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS
0
12. The authority citation for part 1005 continues to read as follows:
Authority: 21 U.S.C. 360ii, 360mm.
0
13. Amend Sec. 1005.11 by revising the second sentence to read as
follows:
Sec. 1005.11 Payment for samples.
* * * Billing for reimbursement should be made by the owner or
consignee to the Food and Drug Administration division where the
shipment was offered for import. * * *
0
14. Amend Sec. 1005.24 to revise paragraphs (b) and (c) to read as
follows:
Sec. 1005.24 Costs of bringing product into compliance.
* * * * *
(b) Per diem in lieu of subsistence of the supervising officer when
away from his or her home station, as provided by law;
(c)(1) The charge for the services of the supervising officer,
which shall include administrative support, shall be computed at a rate
per hour equal to 267 percent of the hourly rate of regular pay of a
grade GS-11/4 employee, except that such services performed by a
customs officer and subject to the provisions of the act of February
13, 1911, as amended (section 5, 36 Stat. 901, as amended (19 U.S.C.
267)), shall be calculated as provided in that act.
(2) The charge for the services of the analyst, which shall include
administrative and laboratory support, shall be computed at a rate per
hour equal to 267 percent of the hourly rate of regular pay of a grade
GS-12/4 employee.
(3) The rate per hour equal to 267 percent of the equivalent hourly
rate of regular pay of the supervising officer (GS-11/4) and the
analyst (GS-12/4) is computed as follows:
Table 1 to Paragraph (c)(3)
------------------------------------------------------------------------
Hours
------------------------------------------------------------------------
Gross number of working hours in 52 40-hour weeks.............. 2,080
Less:
10 legal public holidays--New Year's Day, Birthday of 80
Martin Luther King, Jr., Washington's Birthday, Memorial
Day, Independence Day, Labor Day, Columbus Day, Veterans
Day, Thanksgiving Day, and Christmas Day..................
Annual Leave--26 days...................................... 208
Sick Leave--13 days........................................ 104
--------
Total.................................................. 392
--------
Net number of working hours............................ 1,688
------------------------------------------------------------------------
Gross number of working hours in 52 40-hour weeks.............. 2,080
Working hour equivalent of Government contributions for 176
employee retirement, life insurance, and health benefits
computed at 8\1/2\% of annual rate of pay of employee.........
Equivalent annual working hours................................ 2,256
Support required to equal to 1 person-year..................... 2,256
Equivalent gross annual working hours charged to Food and Drug 4,512
appropriation.................................................
------------------------------------------------------------------------
Note: Ratio of equivalent gross annual number of working hours charged
to Food and Drug appropriation to net number of annual working hours
(4,512/1,688) = 267 pct.
* * * * *
Dated: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17037 Filed 8-17-20; 8:45 am]
BILLING CODE 4164-01-P
