Amendments to Sterility Test Requirements for Biological Products; Correction, 30887-30888 [2012-12594]
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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Rules and Regulations
comments received regarding revocation
of the definition of unblockable drain
covers,’’ dated March 30, 2012.
Commission staff’s summary and
response to these comments follow:
1. Cost of compliance (142 comments)
and dire financial circumstances (131
comments).
Comment: Members of the American
Hotel & Lodging Association, the Illinois
Department of Health, and others assert
that the cost of retrofitting pools again
would put an undue burden on them
and cite to the impact of the poor
economy on their operating revenues
and the loss of revenue that will be
incurred while the pools are closed for
the modifications that will be required
to bring them into compliance.
Commenters in this category also
mention the respondents’ ‘‘dire
financial circumstances’’ as a reason
against the revocation of the
Commission’s April 27, 2010 definition
of ‘‘unblockable drain.’’
Response: Commission staff agrees
that there may be financial hardship,
but only to those who relied upon the
Commission’s interpretive rule and
installed an unblockable drain cover in
lieu of installing a secondary system.
Thus, Commission staff believes it
seems reasonable to provide firms that
relied on the Commission’s prior
interpretation the time to budget and
plan for the expenditure needed to
install a secondary system.
2. Apply prospectively (4 comments).
Comment: Commenters in this
category cited the lack of injuries as a
reason to apply the revocation only to
facilities that are newly constructed or
renovated in the future.
Response: Commission staff does not
agree with prospective application to
new construction or renovation. The
law has required pools to be compliant
with the VGBA for almost four years.
Only firms that relied on the
unblockable drain interpretive rule of
April 27, 2010, and installed VGBAcompliant unblockable drain covers on
or before October 11, 2011, are affected
by the revocation decision. Thus,
prospective application is overly broad,
and applying it to firms that did not
install VGBA-compliant unblockable
drain covers on or before October 11,
2011, would not follow the statutorily
mandated effective date, would create
confusion, and would unduly
complicate enforcement.
3. Comments Requesting Delay of
Enforcement (2 comments).
Comment: Two commenters requested
that the Commission delay the
implementation of enforcement. One
requested that the CPSC delay
implementation of the enforcement of
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the change for one year because they
had relied upon the original
interpretation and installed unblockable
drain covers and now would have to go
back and ‘‘re-do’’ their work, which they
said would penalize them unfairly for
their compliance with the prior
interpretation. The commenter also
noted that the unblockable drain covers
were far more expensive than typical
smaller fittings, and asserted that they
represented a major investment on the
basis that, once the covers were
installed, additional equipment would
not be required. The other commenter
requested that the Commission delay
the implementation date to January 1,
2013, or prior to 2013 operation dates
for seasonal pools and spas. The
commenter also stated that regulated
pools and spas that had already invested
to comply with the requirements of the
VGBA would be required to add
secondary anti-entrapment systems or
make other modifications at
considerable expense, in addition to
expenditures necessary to comply with
state law and U.S. Department of Justice
pool and spa accessibility requirements.
Response: Commission staff agrees
that those who relied upon the
Commission’s interpretive rule and
installed an unblockable drain cover in
lieu of installing a secondary system
will now face additional expenditures to
bring their pools into compliance with
the VGBA. Thus, Commission staff
believes that it seems reasonable to
provide those who installed VGBAcompliant unblockable drain covers on
or before October 11, 2011, time to
budget and plan for the expenditure
needed to install a secondary system.
4. Compliance Date Is Acceptable (1
comment).
Comment: One comment was received
in support of the May 28, 2012,
compliance date. The commenter, the
National Multi Housing Council/
National Apartment Association
(NMHC/NAA), expressed the belief that
if the Commission offered additional
guidance to the regulated community to
assist with compliance, the majority of
their members could comply by the
deadline; but NMHC/NAA urged the
CPSC to reevaluate the progress being
made by pool owners and adjust the
deadline, if necessary.
Response: CPSC staff has a concern
about the number of requests that may
be received for assistance with
compliance and whether the pool
operator is seeking a plan review and
not just limited advice about how to
handle the revocation decision. The
only circumstance in which staff
believes there could be any need for
compliance assistance due to the
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30887
revocation of the unblockable drain
interpretive rule is with respect to pool
operators who relied on the
Commission’s April 27, 2010 decision
and installed VGBA-compliant
unblockable drain covers on or before
October 11, 2011. The guidance to those
firms is that your unblockable drain
cover is VGBA-compliant and does not
need to be removed; but pool operators
need to install a secondary antientrapment system to come into
compliance, unless the pool uses a
gravity drain system or the underlying
drain is unblockable. Accordingly, if a
pool operator installed an unblockable
drain cover over a drain that is
blockable, staff believes it is reasonable
to allow them time to budget and plan
for the expenditure required to install a
secondary anti-entrapment system.
C. Commission Determination
Upon being presented with the staff
briefing package, the Commission voted
to extend the compliance date to May
23, 2013. Only firms that relied on the
unblockable drain interpretive rule of
April 27, 2010, and installed VGBAcompliant unblockable drain covers on
or before October 11, 2011, will have
until May 23, 2013, to install a
secondary system, as necessary. Firms
that did not rely on the unblockable
drain interpretive rule of April 27, 2010,
and did not install VGBA-compliant
unblockable drain covers on or before
October 11, 2011, should be compliant
with the VGBA, and will not have
additional time to come into compliance
if they are not.
Dated: May 17, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2012–12335 Filed 5–23–12; 8:45 a.m.]
BILLING CODE 6355–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 600, 610, and 680
[Docket No. FDA–2011–N–0080]
RIN 0910–AG16
Amendments to Sterility Test
Requirements for Biological Products;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule, correction.
The Food and Drug
Administration (FDA) is correcting a
SUMMARY:
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24MYR1
30888
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Rules and Regulations
final rule that appeared in the Federal
Register of May 3, 2012. (77 FR 26162).
The final rule provides manufacturers of
biological products greater flexibility, as
appropriate, and encourages use of the
most appropriate and state-of-the-art test
methods for assuring the safety of
biological products. The rule was
published with an inaccurate citation in
the codified section of the rule. This
notice corrects that error.
DATES: Effective June 4, 2012.
FOR FURTHER INFORMATION CONTACT: Paul
E. Levine, Jr., Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION: In FR Doc.
2012–10649, appearing on page 26162
in the Federal Register of Thursday,
May 3, 2012, the following correction is
made:
§ 680.3
[Corrected]
1. On page 26175, in the second
column, in Part 680 Additional
Standards for Miscellaneous Products,
in § 680.3 Tests, paragraph (c), in line 4,
‘‘§ 601.12’’ is corrected to read
‘‘§ 610.12’’.
Dated: May 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–12594 Filed 5–23–12; 8:45 a.m.]
BILLING CODE 4160–01–P
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
25 CFR Part 36
[Docket ID: BIA–2012–0001]
RIN 1076–AF10
Heating, Cooling, and Lighting
Standards for Bureau-Funded
Dormitory Facilities
Bureau of Indian Affairs,
Interior.
ACTION: Interim final rule with request
for comments.
AGENCY:
As required by the No Child
Left Behind Act of 2001, the Secretary
of the Interior has developed regulations
using negotiated rulemaking that
address heating, cooling, and lighting
standards for Bureau-funded dormitory
facilities. These regulations also make a
technical change to remove an obsolete
reference.
DATES: This rule is effective on May 24,
2012. Please submit written comments
by June 25, 2012. The incorporation by
srobinson on DSK4SPTVN1PROD with RULES
SUMMARY:
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reference of certain publications listed
in the regulations is approved by the
Director of the Federal Register as of
May 24, 2012.
ADDRESSES: You may submit comments
by any of the following methods:
—Federal rulemaking portal: https://
www.regulations.gov. The rule is
listed under the agency name ‘‘Bureau
of Indian Affairs.’’ The rule has been
assigned Docket ID: BIA–2012–0001.
If you would like to submit comments
through the Federal e-Rulemaking
Portal, go to www.regulations.gov and
do the following. Go to the box
entitled ‘‘Enter Keyword or ID,’’ type
in ‘‘BIA–2012–0001,’’ and click the
‘‘Search’’ button. The next screen will
display the Docket Search Results for
the rulemaking. If you click on BIA–
2012–0001, you can view this rule
and submit a comment. You can also
view any supporting material and any
comments submitted by others.
—Email: Regina.Gilbert@bia.gov.
Include the number 1076–AF10 in the
subject line of the message.
—Fax: (505) 563–3811. Include the
number 1076–AF10 in the subject line
of the message.
—Mail: Regina Gilbert, Office of
Regulatory Affairs & Collaborative
Action, U.S. Department of the
Interior, 1001 Indian School Road
NW., Suite 312, Albuquerque, NM
87104. Include the number 1076–
AF10 in the subject line of the
message.
—Hand delivery: Regina Gilbert, Office
of Regulatory Affairs & Collaborative
Action, U.S. Department of the
Interior, 1001 Indian School Road
NW., Suite 312, Albuquerque, NM
87104. Include the number 1076–
AF10 in the subject line of the
message.
We cannot ensure that comments
received after the close of the comment
period (see DATES) will be included in
the docket for this rulemaking and
considered. Comments sent to an
address other than those listed above
will not be included in the docket for
this rulemaking.
FOR FURTHER INFORMATION CONTACT:
Regina Gilbert, Office of Regulatory
Affairs and Collaborative Action, Office
of the Assistant Secretary—Indian
Affairs, 1001 Indian School Road NW.,
Suite 312, Albuquerque, NM 87104;
telephone (505) 563–3805; fax (505)
563–3811.
SUPPLEMENTARY INFORMATION:
I. Background
II. Description of Changes
III. Procedural Requirements
A. Regulatory Planning and Review (E.O.
12866)
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B. Regulatory Flexibility Act
C. Small Business Regulatory Enforcement
Fairness Act
D. Unfunded Mandates Reform Act
E. Takings (E.O. 12630)
F. Federalism (E.O. 13132)
G. Civil Justice Reform (E.O. 12988)
H. Consultation With Indian Tribes (E.O.
13175)
I. Paperwork Reduction Act
J. National Environmental Policy Act
K. Information Quality Act
L. Effects on the Energy Supply (E.O.
13211)
M. Clarity of This Regulation
N. Public Availability of Comments
O. Determination To Allow Shortened
Public Comment Period
I. Background
The U.S. Government is responsible
for educating American Indian children.
This Federal duty is executed by the
Bureau of Indian Affairs within the
Department of the Interior. The Bureau
funds 183 schools serving American
Indian children. In part because of the
low population densities across much of
Indian country, a number of these
schools include dormitory (‘‘homeliving’’) facilities. Many of these schools
and associated facilities are in poor
physical condition.
The No Child Left Behind Act of 2001
(107 Pub. L. 110: 115 Stat. 1425) (Act)
included provisions intended to
improve the quality of education
provided at Bureau-funded schools, and
the physical condition of the school
facilities. The Act directed the Secretary
of the Interior to establish a negotiated
rulemaking committee, in accordance
with the provisions of the Negotiated
Rulemaking Act, to ensure maximum
contribution by the affected Indian
tribes in responding to the mandates of
the Act.
In 2003, the Secretary established a
negotiated rulemaking committee,
which held a series of meetings to
address the mandates of the Act (the
2003 committee). On April 28, 2005,
final rules developed by the 2003
committee were published in the
Federal Register, addressing six
components of the Act’s mandates:
defining adequate yearly progress;
establishing geographic attendance areas
for Bureau-funded schools; establishing
a formula for the minimum amount
necessary to fund Bureau-funded
schools; establishing a system of
uniform direct funding and support for
Bureau-operated schools; providing
guidelines to ensure the Constitutional
and civil rights of Indian students; and
establishing a method for administering
grants to tribally controlled schools. 70
FR 22178.
E:\FR\FM\24MYR1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Rules and Regulations]
[Pages 30887-30888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12594]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 600, 610, and 680
[Docket No. FDA-2011-N-0080]
RIN 0910-AG16
Amendments to Sterility Test Requirements for Biological
Products; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule, correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a
[[Page 30888]]
final rule that appeared in the Federal Register of May 3, 2012. (77 FR
26162). The final rule provides manufacturers of biological products
greater flexibility, as appropriate, and encourages use of the most
appropriate and state-of-the-art test methods for assuring the safety
of biological products. The rule was published with an inaccurate
citation in the codified section of the rule. This notice corrects that
error.
DATES: Effective June 4, 2012.
FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION: In FR Doc. 2012-10649, appearing on page
26162 in the Federal Register of Thursday, May 3, 2012, the following
correction is made:
Sec. 680.3 [Corrected]
1. On page 26175, in the second column, in Part 680 Additional
Standards for Miscellaneous Products, in Sec. 680.3 Tests, paragraph
(c), in line 4, ``Sec. 601.12'' is corrected to read ``Sec. 610.12''.
Dated: May 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12594 Filed 5-23-12; 8:45 a.m.]
BILLING CODE 4160-01-P
