[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
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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]
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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]
BILLING CODE 4163-18-P