Document ID: FDA-2019-N-0011-0002
Agency: fda
Document Type: Rule
Title: Office of Regulatory Affairs Division Director; Technical Amendments
Posted Date: 2020-08-18T04:00Z

[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