[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Rules and Regulations]
[Pages 9412-9413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03582]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 800

[Docket No. FDA-1977-N-0222]


Administrative Detention; Corrections

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendment.

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SUMMARY: The Food and Drug Administration (FDA) published a document in 
the Federal Register on Friday, March 9, 1979 (44 FR 13239). The 
document established administrative detention procedures for devices 
intended for human use believed to be adulterated or misbranded. The 
document was published with a citation in the first column on page 
13240 that subsequently was changed by the Nutrition Labeling and 
Education Act Amendments of 1993. In addition, the document was 
published with one typographical error in the first column on page 
13241. This document corrects these errors.

DATES: This correction is effective February 19, 2014.

FOR FURTHER INFORMATION CONTACT: Jan B. Welch, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3412, 301-796-5776, FAX: 301-847-8136, 
jan.welch@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is correcting a final rule that appeared 
in the Federal Register on Friday, March 9, 1979 (44 FR 13239). The 
final rule established administrative detention procedures for devices 
intended for human use believed to be adulterated or misbranded. The 
document was published with a citation to section 201(y) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(y)) (the FD&C Act) in the 
first column on page 13240 (Sec.  800.55(g)(1) (21 CFR 800.55(g)(1)) 
that subsequently was changed to section 201(x) of the FD&C Act by 
section 3(b) of the Nutrition Labeling and Education Act Amendments of 
1993 (Pub. L. 103-80). In addition, the document was published with one 
typographical error in the first column on page 13241 (Sec.  
800.55(k)(1)) in which the word ``is'' should have been the word 
``in''. This document updates the statutory reference in Sec.  
800.55(g)(1) and corrects the typographical error in Sec.  
800.55(k)(1).
    Publication of this rule constitutes final action under the 
Administrative Procedure Act (5 U.S.C. 553). This amendment to the 
regulations provides only a technical change and corrects a 
nonsubstantive error. FDA therefore, for good cause, finds under 5 
U.S.C. 553(b)(3)(B) that notice and public comment are unnecessary, and 
under 5 U.S.C. 553(d)(3) that the rule can become effective upon 
publication.
    FDA has determined under 21 CFR 25.30(i) that this final rule is of 
a type that, as a class, does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in Sec.  800.55 have been approved under OMB 
control number 0910-0114, which expires April 30, 2016.

List of Subjects in 21 CFR Part 800

    Administrative practice and procedure; Medical devices; Ophthalmic 
goods and services; Packaging and containers; Reporting and 
recordkeeping requirements.

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

PART 800--GENERAL

0
1. The authority citation for 21 CFR Part 800 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 
361, 362, 371.


0
2. In Sec.  800.55, revise paragraph (g)(1) and the first sentence of 
paragraph (k) to read as follows:


Sec.  800.55  Administrative detention.

* * * * *
    (g) Appeal of a detention order. (1) A person who would be entitled 
to claim

[[Page 9413]]

the devices, if seized, may appeal a detention order. Any appeal shall 
be submitted in writing to the FDA District Director in whose district 
the devices are located within 5 working days of receipt of a detention 
order. If the appeal includes a request for an informal hearing, as 
defined in section 201(x) of the act, the appellant shall request 
either that a hearing be held within 5 working days after the appeal is 
filed or that the hearing be held at a later date, which shall not be 
later than 20 calendar days after receipt of a detention order.
* * * * *
    (k) Recordkeeping requirements. (1) After issuance of a detention 
order under paragraph (d) of this section, the owner, operator, or 
agent in charge of any factory, warehouse, other establishment, or 
consulting laboratory where detained devices are manufactured, 
processed, packed, or held shall have, or establish, and maintain 
adequate records relating to how the detained devices may have become 
adulterated or misbranded, records on any distribution of the devices 
before and after the detention period, records on the correlation of 
any in-process detained devices that are put in final form under 
paragraph (h) of this section to the completed devices, records of any 
changes in, or processing of, the devices permitted under the detention 
order, and records of any other movement under paragraph (h) of this 
section. * * *
* * * * *

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03582 Filed 2-18-14; 8:45 am]
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