[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Rules and Regulations]
[Page 35878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 71

[Docket No. CDC-2012-0003]
RIN 0920-AA47


Establishment of User Fees for Filovirus Testing of Nonhuman 
Primate Liver Samples

AGENCY: Centers for Disease Control and Prevention (HHS/CDC), 
Department of Health and Human Services (HHS).

ACTION: Correcting amendment.

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SUMMARY: On February 10, 2012, the Centers for Disease Control and 
Prevention (CDC), within the Department of Health and Human Services 
(HHS) published a Direct Final Rule (DFR) that solicited public comment 
on the establishment of user fees for filovirus testing of all nonhuman 
primates that die during the HHS/CDC-required 31-day quarantine period 
for any reason other than trauma. That document incorrectly listed the 
effective date as March 12, 2012. On February 10, 2012, HHS/CDC also 
published in the Federal Register a companion Notice of Proposed 
Rulemaking (NPRM) (77 FR 7109) that proposed identical filovirus 
testing and user fee requirements. In both the DFR and NPRM, HHS/CDC 
indicated that if it did not receive any significant adverse comments 
by April 10, 2012, it would publish a document in the Federal Register 
withdrawing the NPRM and confirming the effective date of the DFR 
within 30 days after the end of the comment period.
    Because of the error in effective date the DFR took effect prior to 
the expiration of the comment period. Because of this error and due to 
receiving significant adverse public comments, HHS/CDC is amending 42 
CFR 71.53 by removing paragraph (j) which will have the same effect as 
the withdrawal of the DFR. HHS/CDC will carefully review the comments 
received on the notice of proposed rulemaking published on February 10, 
2012.

DATES: This action is effective June 15, 2012.

FOR FURTHER INFORMATION CONTACT: For questions concerning this 
document: Ashley A. Marrone, JD, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE., Mailstop E-03, Atlanta, Georgia 
30333; telephone 404-498-1600. For information concerning program 
operations: Dr. Robert Mullan, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE., Mailstop E-03, Atlanta, Georgia 
30333; telephone 404-498-1600.

SUPPLEMENTARY INFORMATION: On February 10, 2012 HHS/CDC published a 
Direct Final Rule (DFR) (77 FR 6971) amending 42 CFR 71.53 by adding a 
new paragraph (j) to establish a user fee for filovirus testing of 
nonhuman primates. HHS/CDC took this action because (1) testing is no 
longer being offered by the only private, commercial laboratory that 
previously performed these tests and (2) we believed that these 
requirements were non-controversial and unlikely to generate 
significant adverse comment. The DFR incorrectly listed the effective 
date as March 12, 2012. On February 10, 2012, HHS/CDC also published a 
companion Notice of Proposed Rulemaking (NPRM) (77 FR 7109) that 
proposed identical filovirus testing and user fee requirements in the 
Federal Register. In both the DFR and NPRM, HHS/CDC indicated that if 
it did not receive any significant adverse comments by April 10, 2012, 
it would publish a document in the Federal Register withdrawing the 
notice of proposed rulemaking and confirming the effective date of the 
direct final rule within 30 days after the end of the comment period. 
Because of the error in effective date the DFR took effect prior to the 
expiration of the comment period.
    HHS/CDC is now amending 42 CFR 71.53 by removing paragraph (j) 
which will have the same effect as if HHS/CDC had withdrawn the DFR. 
HHS/CDC is taking this action because of the error in effective date 
and due to having received significant adverse public comments. HHS/CDC 
will carefully review the comments received on the notice of proposed 
rulemaking published on February 10, 2012.

List of Subjects in 42 CFR Part 71

    Communicable diseases, Public health, Quarantine, Reporting and 
recordkeeping requirements, Testing, User fees.

    Accordingly, 42 CFR part 71 is corrected by making the following 
correcting amendment:

PART 71--FOREIGN QUARANTINE

0
1. The authority citation for part 71 continues to read as follows:

    Authority: Secs. 215 and 311 of the Public Health Service (PHS) 
Act, as amended (42 U.S.C. 216, 243); section 361-369, PHS Act, as 
amended (42 U.S.C. 264-272); 31 U.S.C. 9701.


Sec.  71.53  [Amended]

0
2. Effective June 15, 2012, amend Sec.  71.53 by removing paragraph 
(j).

    Dated: June 6, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-14603 Filed 6-14-12; 8:45 am]
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