[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Notices]
[Page 18788-18789]
[DOCID:fr12ap06-125]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53603; File No. SR-CBOE-2005-112]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Granting Permanent Approval of a Pilot Program
Relating to Access to the Exchange's Hybrid Automatic Execution System

April 5, 2006.
    On December 30, 2005, the Chicago Board Options Exchange,
Incorporated (``Exchange'' or ``CBOE'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ to make permanent the pilot program in
CBOE Rule 6.13 relating to access to the Exchange's automatic execution
system. The proposed rule change was published for comment in the
Federal Register on March 6, 2006.\3\ The Commission received no
comments on the proposal. This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 53377 (February 27,
2006), 71 FR 11250.
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    The pilot program the Exchange seeks to make permanent was
initiated in July 2004, was subsequently extended twice, and is
currently scheduled to expire on October 12, 2006.\4\ Under the pilot
program, pursuant to CBOE Rule 6.13(b)(i)(C)(iii), orders from market
makers and specialists on an options exchange (``options Market
Makers'') and stock exchange specialists,\5\ with respect to their
specialty securities, are eligible for automatic execution through the
Exchange's Hybrid Trading System (``Hybrid''), subject to a 15-second
limitation \6\ on orders on the same side of the market in an options
class for an account or accounts of the same beneficial owner. The
Exchange believes that the pilot program has been successful and has
helped to contribute to the maintenance of efficient markets and to
attract volume to the Exchange.
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    \4\ See Securities Exchange Act Release Nos. 50005 (July 12,
2004), 69 FR 43032 (July 19, 2004) (approving the pilot program);
51030 (January 12, 2005), 70 FR 3404 (January 24, 2005) (extending
the pilot program until October 12, 2005); and 52494 (September 22,
2005), 70 FR 56943 (September 29, 2005) (extending the pilot program
until October 12, 2006).
    \5\ By its terms, CBOE Rule 6.13(b)(i)(C)(iii) applies to orders
eligible for submission pursuant to CBOE Rule 6.13(b)(i)(C)(ii),
which relates to options Market Makers and certain stock exchange
specialists.
    \6\ As allowed under CBOE Rule 6.13(b)(i)(C)(iii), the
Exchange's floor procedure committees determined to shorten to five
seconds (from 15 seconds) the period required between entry of
multiple market maker orders (including non-CBOE market maker
orders) on the same side of the market in an option class for an
account or accounts of the same beneficial owner using Hybrid. This
change went into effect on July 18, 2005 and was announced to the
Exchange's membership via Regulatory Circular RG05-61. The Exchange
clarified that such reduction in the time period to five seconds
applies to all of the market participants subject to the pilot
program under CBOE Rule 6.13(b)(i)(C)(iii). Telephone conversation
between Jennifer M. Lamie, Managing Senior Attorney, Exchange, and
Kim M. Allen, Special Counsel, Division of Market Regulation,
Commission, on March 29, 2006.
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    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of Section 6 of the Act
\7\ and the rules and regulations thereunder applicable to a national
securities exchange.\8\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\9\
which requires, among other things, that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and

practices, to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest. The Commission believes that prohibiting members from
causing the entry into Hybrid of more than one order from options
Market Makers or stock exchange specialists for the same beneficial
account within a maximum 15-second period should help reduce the risk
of exposure of CBOE market makers. The Commission notes that the 15-
second restriction set forth in the rule provides a sufficient period
to allow CBOE market makers to change their quotations following an
execution, without placing an undue burden on market participants
seeking to execute transactions on the Exchange.\10\ The Commission
further notes that market participants subject to the 15-second
restriction will still be permitted to send orders to the Exchange for
execution through the Intermarket Option Linkage pursuant to the terms
of the Plan for the Purpose of Creating and Operating an Intermarket
Option Linkage.
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    \7\ 15 U.S.C. 78f.
    \8\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(5).
    \10\ The Commission notes that the Exchange may not take
punitive action against any non-member options market maker or stock
exchange specialist who submits an order to a CBOE member for entry
into Hybrid in the event that the CBOE member violates CBOE Rule
6.13(b)(i)(C)(iii).
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\11\ that the proposed rule change (SR-CBOE-2005-112) is approved.
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    \11\ 15 U.S.C. 78s(b)(2).
    \12\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
Nancy M. Morris,
Secretary.
[FR Doc. E6-5365 Filed 4-11-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Notices]
[Pages 28604-28605]
[FR Doc No: 2012-11688]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0454]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Questions and Answers
Regarding the Labeling of Nonprescription Human Drug Products Marketed
Without an Approved Application as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This guidance solicits comments on ``Questions and Answers
Regarding the Labeling of Nonprescription Human Drug Products Marketed
Without an Approved Application as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act.''

DATES: Submit either electronic or written comments on the collection
of information by July 16, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela,Office of
Information Management, Food and Drug Administration,1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Questions and Answers Regarding the Labeling
of Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act--(OMB Control Number 0910-0640)--Extension

    On December 22, 2006, the President signed into law the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Pub. L.
109-462, 120 Stat. 3469). This law amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) with respect to serious adverse event
reporting for dietary supplements and nonprescription drugs marketed
without an approved application.
    Section 502(x) of the FD&C Act (21 U.S.C. 352(x)), which was added
by Public Law 109-462, requires the label of a nonprescription drug
product marketed without an approved application in the United States
to include a domestic address or domestic telephone number through
which a responsible person may receive a report of a serious adverse
event associated with the product. The guidance document contains
questions and answers relating to this labeling requirement and
provides guidance to industry on the following topics: (1) The meaning
of ``domestic address'' for purposes of the labeling requirements of
section 502(x) of the FD&C Act; (2) FDA's recommendation for the use of
an introductory statement before the domestic address or phone number
that is required to appear on the product label under section 502(x) of
the FD&C Act; and (3) FDA's intent regarding enforcing the labeling
requirements of section 502(x) of the FD&C Act. Separate guidance,
issued by the Center for Food Safety and Applied Nutrition on reporting
for dietary supplements, is announced elsewhere in the Federal
Register.
    Title: Guidance for Industry on Questions and Answers Regarding the
Labeling of Nonprescription Human Drug Products Marketed Without an
Approved Application as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.
    Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors whose name
(pursuant to section 502(b)(1) of the FD&C Act) appears on the label of
a nonprescription drug product marketed in the United States without an
approved application.

    Burden Estimate: FDA is requesting public comment on the estimated
one-time reporting burden from these respondents, as required by 502(x)
of the FD&C Act and described in the guidance ``Questions and Answers
Regarding the Labeling of Nonprescription Human Drug Products Marketed
Without an Approved Application as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act.'' The estimates for
one-time reporting are based on FDA's knowledge of nonprescription drug
product labeling in the United States, whether or not marketed under an
approved application.
    FDA estimates the burden of this collection of information as
follows:

                                                    Table 1--Estimated One-Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                                                                        Number of      responses per        Total       Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic address or phone number labeling requirement (21 U.S.C.                200              500          100,000                4          400,000
 502(x)) and recommendation to clarify its purpose.................
--------------------------------------------------------------------------------------------------------------------------------------------------------
There are no capital costs or maintenance and operating costs associated with this collection of information.

    As indicated in Table 1 of this document, we estimate that
approximately 200 manufacturers will revise approximately 100,000
labels to add a full domestic address and a domestic telephone number,
and should they choose to adopt the draft guidance's recommendation, to
add a statement identifying the purpose of the domestic address or
telephone number. FDA believes that designing the label change should
not take longer than 4 hours per label. Automated printing of the
labels should only require a few seconds per label. This estimate
accounts for the possibility that every manufacturer will make label
revision, which is unlikely. Because the majority of over-the-counter
drug product labels currently have a domestic telephone number that
satisfies the requirement, we believe many manufacturers will opt not
to adopt the guidance's recommendation to add a statement identifying
the purpose of the address or telephone number, significantly reducing
the number of total responses. However, assuming that all labels are
revised, we estimate a one-time reporting burden for this information
collection of 400,000 hours.

    Dated: May 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11688 Filed 5-14-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Proposed Rules]
[Pages 72888-72891]
[FR Doc No: 2011-30277]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. NHTSA-2011-0160]

Federal Motor Vehicle Safety Standards; Small Business Impacts of
Motor Vehicle Safety

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of regulatory review; Request for comments.

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SUMMARY: NHTSA seeks comments on the economic impact of its regulations
on small entities. As required by Section 610 of the Regulatory
Flexibility Act, we are attempting to identify rules that may have a
significant economic impact on a substantial number of small entities.
We also request comments on ways to make these regulations easier to
read and understand. The focus of this notice is rules that
specifically relate to school buses and other buses.

DATES: You should submit comments early enough to ensure that Docket
Management receives them not later than January 27, 2012.

ADDRESSES: You may submit comments [identified by DOT Docket ID Number
NHTSA-2011-0160] by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.

     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments and
additional information see the Comments heading of the Supplementary
Information section of this document. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the Privacy Act heading
below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketsInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Juanita Kavalauskas, Office of
Regulatory Analysis, Office of Regulatory Analysis and Evaluation,
National Highway Traffic Safety Administration, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590
(telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

I. Section 610 of the Regulatory Flexibility Act

A. Background and Purpose

    Section 610 of the Regulatory Flexibility Act of 1980 (Pub. L. 96-
354), as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Pub. L. 104-121), requires agencies to conduct periodic
reviews of final rules that have a significant economic impact on a
substantial number of small business entities. The purpose of the
reviews is to determine whether such rules should be continued without
change, or should be amended or rescinded, consistent with the
objectives of applicable statutes, to minimize any significant economic
impact of the rules on a substantial number of such small entities.

B. Review Schedule

    The Department of Transportation (DOT) published its Semiannual
Regulatory Agenda on November 22, 1999, listing in Appendix D (64 FR
64684) those regulations that each operating administration will review
under section 610 during the next 12 months. Appendix D contained DOT's
10-year review plan for all of its existing regulations. On November
24, 2008, NHTSA published in the Federal Register (73 FR 71401) a
revised 10-year review plan for its existing regulations.
    The National Highway Traffic Safety Administration (NHTSA, ``we'')
has divided its rules into 10 groups by subject area. Each group will
be reviewed once every 10 years, undergoing a two-stage process--an
Analysis Year and a Review Year. For purposes of these reviews, a year
will coincide with the fall-to-fall publication schedule of the
Semiannual Regulatory Agenda. The newly revised 10-year plan will
assess years 9 and 10 of the old plan in years 1 and 2 of the new plan.
Year 1 (2008) began in the fall of 2008 and will end in the fall of
2009; Year 2 (2009) will begin in the fall of 2009 and will end in the
fall of 2010; and so on.
    During the Analysis Year, we will request public comment on and
analyze each of the rules in a given year's group to determine whether
any rule has a significant impact on a substantial number of small
entities and, thus, requires review in accordance with section 610 of
the Regulatory Flexibility Act. In each fall's Regulatory Agenda, we
will publish the results of the analyses we completed during the
previous year. For rules that have subparts, or other discrete sections
of rules that do have a significant impact on a substantial number of
small entities, we will announce that we will be conducting a formal
section 610 review during the following 12 months.
    The section 610 review will determine whether a specific rule
should be revised or revoked to lessen its impact on small entities. We
will consider: (1) The continued need for the rule; (2) the nature of
complaints or comments received from the public; (3) the complexity of
the rule; (4) the extent to which the rule overlaps, duplicates, or
conflicts with other federal rules or with state or local government
rules; and (5) the length of time since the rule has been evaluated or
the degree to which technology, economic conditions, or other factors
have changed in the area affected by the rule. At the end of the Review
Year, we will publish the results of our review. The following table
shows the 10-year analysis and review schedule:

                       National Highway Traffic Safety Administration Section 610 Reviews
----------------------------------------------------------------------------------------------------------------
                  Year                        Regulations to be reviewed        Analysis year      Review year
----------------------------------------------------------------------------------------------------------------
1.......................................  49 CFR 571.223 through 571.500,                 2008              2009
                                           and parts 575 and 579.
2.......................................  23 CFR parts 1200 and 1300........              2009              2010
3.......................................  49 CFR parts 501 through 526 and                2010              2011
                                           571.213.
4.......................................  49 CFR 571.131, 571.217, 571.220,               2011              2012
                                           571.221, and 571.222.
5.......................................  49 CFR 571.101 through 571.110,                 2012              2013
                                           and 571.135, 571.138 and 571.139.
6.......................................  49 CFR parts 529 through 578,                   2013              2014
                                           except parts 571 and 575.
7.......................................  49 CFR 571.111 through 571.129 and              2014              2015
                                           parts 580 through 588.
8.......................................  49 CFR 571.201 through 571.212....              2015              2016
9.......................................  49 CFR 571.214 through 571.219,                 2016              2017
                                           except 571.217.
10......................................  49 CFR parts 591 through 595 and                2017              2018
                                           new parts and subparts.
----------------------------------------------------------------------------------------------------------------

C. Regulations Under Analysis

    During Year 4, we will continue to conduct a preliminary assessment
of the following: 49 CFR 571.131, 571.217, 571.220, 571.221, and
571.222.

------------------------------------------------------------------------
              Section                               Title
------------------------------------------------------------------------
571.131...........................  School bus pedestrian safety
                                     devices.
571.217...........................  Bus emergency exits and window
                                     retention and release.
571.220...........................  School bus rollover protection.
571.221...........................  School bus body joint strength.
571.222...........................  School bus passenger seating and
                                     crash protection.
------------------------------------------------------------------------

    We are seeking comments on whether any requirements in 49 CFR
571.131, 571.217, 571.220, 571.221, and 571.222 have a significant
economic impact on a substantial number of small entities. ``Small
entities'' include small businesses, not-for-profit organizations that
are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations under 50,000.
Business entities are generally defined as small businesses by Standard
Industrial Classification (SIC) code, for the purposes of receiving
Small Business Administration (SBA) assistance. Size standards
established by SBA in 13 CFR 121.201 are expressed either in number of
employees or annual receipts in millions of dollars, unless otherwise
specified. The number of employees or annual receipts indicates the
maximum allowed for a concern and its affiliates to be considered
small. If your business or organization is a small entity and if any of
the requirements in 49 CFR 571.131, 571.217, 571.220, 571.221, and
571.222 have a significant economic impact on your business or
organization, please submit a comment to explain how and to what degree
these rules affect you, the extent of the economic impact on your
business or organization, and why you believe the economic impact is
significant.
    If the agency determines that there is a significant economic
impact on a substantial number of small entities, it will ask for
comment in a subsequent notice during the Review Year on how these
impacts could be reduced without reducing safety.

II. Plain Language

A. Background and Purpose

    Executive Order 12866 and the President's memorandum of June 1,
1998, require each agency to write all rules in plain language.
Application of the principles of plain language includes consideration
of the following questions:
     Have we organized the material to suit the public's needs?
     Are the requirements in the rule clearly stated?
     Does the rule contain technical language or jargon that is
not clear?
     Would a different format (grouping and order of sections,
use of headings, paragraphing) make the rule easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or
diagrams?
     What else could we do to make the rule easier to
understand?
    If you have any responses to these questions, please include them
in your comments on this document.

B. Review Schedule

    In conjunction with our section 610 reviews, we will be performing
plain language reviews over a ten-year period on a schedule consistent
with the section 610 review schedule. We will review 49 CFR 571.131,
571.217, 571.220, 571.221, and 571.222 to determine if these
regulations can be reorganized and/or rewritten to make them easier to
read, understand, and use. We encourage interested persons to submit
draft regulatory language that clearly and simply communicates
regulatory requirements, and other recommendations, such as for putting
information in tables that may make the regulations easier to use.

Comments

How do I prepare and submit comments?

    Your comments must be written and in English. To ensure that your
comments are correctly filed in the Docket, please include the docket
number of this document in your comments.
    Your comments must not be more than 15 pages long. (49 CFR 553.21.)
We established this limit to encourage you to write your primary
comments in a concise fashion. However, you may attach necessary
additional documents to your comments. There is no limit on the length
of the attachments.
    Please submit two copies of your comments, including the
attachments, to Docket Management at the address given above under
ADDRESSES.
    Please note that pursuant to the Data Quality Act, in order for
substantive data to be relied upon and used by the agency, it must meet
the information quality standards set forth in the OMB and DOT Data
Quality Act guidelines. Accordingly, we encourage you to consult the
guidelines in preparing your comments. OMB's guidelines may be accessed
at http://www.whitehouse.gov/omb/fedreg/reproducible.html. DOT's
guidelines may be accessed at http://dmses.dot.gov/submit/DataQualityGuidelines.pdf.

How can I be sure that my comments were received?

    If you wish Docket Management to notify you upon its receipt of
your comments, enclose a self-addressed, stamped postcard in the
envelope containing your comments. Upon receiving your comments, Docket
Management will return the postcard by mail.

How do I submit confidential business information?

    If you wish to submit any information under a claim of
confidentiality, you should submit three copies of your complete
submission, including the information you claim to be confidential
business information, to the Chief Counsel, NHTSA, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590. In
addition, you should submit two copies, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above under ADDRESSES. When you send a comment containing
information claimed to be confidential business information, you should
include a cover letter setting forth the information specified in our
confidential business information regulation. (49 CFR part 512.)

Will the agency consider late comments?

    We will consider all comments that Docket Management receives
before the close of business on the comment closing date indicated
above under DATES. To the extent possible, we will also consider
comments that Docket Management receives after that date.

How can I read the comments submitted by other people?

    You may read the comments received by Docket Management at the
address given above under ADDRESSES. The hours of the Docket are
indicated above in the same location.
    You may also see the comments on the Internet. To read the comments
on the Internet, take the following steps:
    (1) Go to the Federal Docket Management System (FDMS) at http://regulations.gov.
    (2) FDMS provides two basic methods of searching to retrieve
dockets and docket materials that are available in the system: (a)
``Quick Search'' to search using a full-text search engine, or (b)
``Advanced Search,'' which displays various indexed fields such as the
docket name, docket identification number, phase of the action,
initiating office, date of issuance, document title, document
identification number, type of document, Federal Register reference,
CFR citation, etc. Each data field in the advanced search may be
searched independently or in combination with other fields, as desired.
Each search yields a simultaneous display of all available information
found in FDMS that is relevant to the requested subject or topic.
    (3) You may download the comments. However, since the comments are

imaged documents, instead of word processing documents, the ``pdf''
versions of the documents are word searchable.
    Please note that even after the comment closing date, we will
continue to file relevant information in the Docket as it becomes
available. Further, some people may submit late comments. Accordingly,
we recommend that you periodically check the Docket for new material.

Terry Shelton,
Associate Administrator for the National Center for Statistics and
Analysis.
[FR Doc. 2011-30277 Filed 11-25-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: June 24, 2008 (Volume 73, Number 122)]
[Notices]
[Page 35694-35699]
[DOCID:fr24jn08-77]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0345]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practices and Related
Regulations for Blood and Blood Components; and Requirements for Donor
Testing, Donor Notification, and ``Lookback''

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to FDA's regulation of current good manufacturing
practice and related regulations for blood and blood components; and
requirements for donor testing, donor notification, and ``lookback.''

DATES:  Submit written or electronic comments on the collection of
information by August 25, 2008.

ADDRESSES:  Submit electronic comments on the collection of information
to: http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto,Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on

respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.

Current Good Manufacturing Practice and Related Regulations for Blood
and Blood Components; and Requirements for Donor Testing, Donor
Notification, and ``Lookback'' (OMB Control Number 0910-0116)--
Extension

    All blood and blood components introduced or delivered for
introduction into interstate commerce are subject to section 351(a) of
the Public Health Service Act (PHS Act) (42 U.S.C. 262). Section 351(a)
requires that manufacturers of biological products, which include blood
and blood components intended for further manufacture into injectable
products, have a license, issued upon a demonstration that the product
is safe, pure and potent and that the manufacturing establishment meets
all applicable standards, including those prescribed in the FDA
regulations designed to ensure the continued safety, purity, and
potency of the product. In addition, under section 361 of the PHS Act
(42 U.S.C. 264), by delegation from the Secretary of Health and Human
Services, FDA may make and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases from
foreign countries into the States or possessions, or from one State or
possession into any other State or possession.
    Section 351(j) of the PHS Act states that the Federal Food, Drug,
and Cosmetic (FD&C) Act also applies to biological products. Blood and
blood components for transfusion or for further manufacture into
injectable products are drugs, as that term is defined in section
201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). Because blood and
blood components are drugs under the act, blood and plasma
establishments must comply with the substantive provisions and related
regulatory scheme of the FD&C Act. For example, under section 501 of
the FD&C Act (21 U.S.C. 351(a)), drugs are deemed ``adulterated'' if
the methods used in their manufacturing, processing, packing, or
holding do not conform to current good manufacturing practice (CGMP)
and related regulations.
    The CGMP regulations (part 606) (21 CFR part 606)) and related
regulations implement FDA's statutory authority to ensure the safety,
purity, and potency of blood and blood components. The public health
objective in testing human blood donors for evidence of infection due
to communicable disease agents and in notifying donors is to prevent
the transmission of communicable disease. For example, the ``lookback''
requirements are intended to help ensure the continued safety of the
blood supply by providing necessary information to users of blood and
blood components and appropriate notification of recipients of
transfusion who are at increased risk for transmitting human
immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
    The information collection requirements in the CGMP, donor testing,
donor notification, and ``lookback'' regulations provide FDA with the
necessary information to perform its duty to ensure the safety, purity,
and potency of blood and blood components. These requirements establish
accountability and traceability in the processing and handling of blood
and blood components and enable FDA to perform meaningful inspections.
The recordkeeping requirements serve preventive and remedial purposes.
The disclosure requirements identify the various blood and blood
components and important properties of the product, demonstrate that
the CGMP requirements have been met, and facilitate the tracing of a
product back to its original source. The reporting requirements inform
FDA of any deviations that occur and that may require immediate
corrective action.
    Under the reporting requirements, Sec.  606.170(b), in brief,
requires that facilities notify FDA's Center for Biologics Evaluation
and Research (CBER), as soon as possible after confirming a
complication of blood collection or transfusion to be fatal. The
collecting facility is to report donor fatalities, and the
compatibility testing facility is to report recipient fatalities. The
regulation also requires the reporting facility to submit a written
report of the investigation within 7 days after the fatality. In fiscal
years 2006 and 2007, FDA received, on average, 100 of these reports.
    Section 610.40(c)(1)(ii) (21 CFR 610.40(c)(1)(ii)), in brief,
requires that each donation dedicated to a single identified recipient
be labeled as required under Sec.  606.121 and with a label entitled
``INTENDED RECIPIENT INFORMATION LABEL'' containing the name and
identifying information of the recipient.
    Section 610.40(g)(2) (21 CFR 610.40(g)(2)) requires an
establishment to obtain written approval from FDA to ship human blood
or blood components for further manufacturing use prior to completion
of testing for evidence of infection due to certain communicable
disease agents.
    Section 610.40(h)(2)(ii)(A) (21 CFR 610.40(h)(2)(ii)(A)), in brief,
requires an establishment to obtain written approval from FDA to use or
ship human blood or blood components found to be reactive by a
screening test for evidence of certain communicable disease agent(s) or
collected from a donor with a record of a reactive screening test.
Furthermore, Sec.  610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) (21 CFR
610.40(h)(2)(ii)(C) and (h)(2)(ii)(D)), in brief, requires an
establishment to label certain reactive human blood and blood
components with the appropriate screening test results, and, if they
are intended for further manufacturing use into injectable products,
include a statement on the label indicating the exempted use
specifically approved by FDA. Finally, Sec.  610.40(h)(2)(vi) (21 CFR
610.40(h)(2)(vi)) requires each donation of human blood or blood
components, excluding Source Plasma, that tests reactive by a screening
test for syphilis and is determined to be a biological false positive
to be labeled with both test results.
    Section 610.42(a) (21 CFR 610.42(a)) requires a warning statement
``indicating that the product was manufactured from a donation found to
be reactive by a screening test for evidence of infection due to the
identified communicable disease agent(s)'' in the labeling for medical
devices containing human blood or a blood component found to be
reactive by a screening test for evidence of infection due to a
communicable disease agent(s) or syphilis.
    In brief, Sec. Sec.  610.46 and 610.47 (21 CFR 610.46 and 610.47)
require blood collecting establishments to establish, maintain, and
follow an appropriate system for performing HIV and HCV prospective
``lookback'' when: (1) A donor tests reactive for evidence of HIV or
HCV infection or (2) the collecting establishment becomes aware of
other reliable test results or information indicating evidence of HIV
or HCV infection (``prospective lookback'') (see Sec. Sec.
610.46(a)(1) and 610.47(a)(1)). The requirement for ``an appropriate
system'' requires the collecting establishment to design standard
operating procedures (SOPs) to identify and quarantine all blood and
blood components previously collected from a donor who later tests
reactive for evidence of HIV or HCV infection, or when the collecting
establishment is made aware of other reliable test results or
information indicating evidence of HIV or HCV infection. Within 3
calendar days of the donor testing reactive by an HIV or HCV screening
test or the collecting establishment

becoming aware of other reliable test results or information, the
collecting establishment must, among other things, notify consignees to
quarantine all identified previously collected in-date blood and blood
components (Sec. Sec.  610.46(a)(1)(ii)(B) and 610.47(a)(1)(ii)(B))
and, within 45 days, notify the consignees of supplemental test
results, or the results of a reactive screening test if there is no
available supplemental test that is approved for such use by FDA
(Sec. Sec.  610.46(a)(3) and 610.47(a)(3)).
    Consignees also must establish, maintain, and follow an appropriate
system for performing HIV and HCV ``lookback'' when notified by the
collecting establishment that they have received blood and blood
components previously collected from donors who later tested reactive
for evidence of HIV or HCV infection, or when the collecting
establishment is made aware of other reliable test results or
information indicating evidence of HIV or HCV infection in a donor
(Sec. Sec.  610.46(b) and 610.47(b)). This provision for a system
requires the consignee to establish SOPs for, among other things,
notifying transfusion recipients of blood and blood components, or the
recipient's physician of record or legal representative, when such
action is indicated by the results of the supplemental (additional,
more specific) tests or a reactive screening test if there is no
available supplemental test that is approved for such use by FDA, or if
under an investigational new drug application (IND) or an
investigational device exemption (IDE), is exempted for such use by
FDA. The consignee must make reasonable attempts to perform the
notification within 12 weeks of receipt of the supplemental test result
or receipt of a reactive screening test result when there is no
available supplemental test that is approved for such use by FDA, or if
under an IND or IDE, is exempted for such use by FDA (Sec. Sec.
610.46(b)(3) and 610.47(b)(3)).
    Section 630.6(a) (21 CFR 630.6(a)) requires an establishment to
make reasonable attempts to notify any donor who has been deferred as
required by Sec.  610.41 (21 CFR 610.41), or who has been determined
not to be eligible as a donor. Section 630.6(d)(1) requires an
establishment to provide certain information to the referring physician
of an autologous donor who is deferred based on the results of tests as
described in Sec.  610.41.
    Under the recordkeeping requirements, Sec.  606.100(b), in brief,
requires that written SOPs be maintained for all steps to be followed
in the collection, processing, compatibility testing, storage, and
distribution of blood and blood components used for transfusion and
further manufacturing purposes. Section 606.100(c) requires the review
of all records pertinent to the lot or unit of blood prior to release
or distribution. Any unexplained discrepancy or the failure of a lot or
unit of final product to meet any of its specifications must be
thoroughly investigated, and the investigation, including conclusions
and followup, must be recorded.
    In brief, Sec.  606.110(a) provides that the use of
plateletpheresis and leukaphesis procedures to obtain a product for a
specific recipient may be at variance with the additional standards for
that specific product if, among other things, the physician certifies
in writing that the donor's health permits plateletpheresis or
leukapheresis. Section 606.110(b) requires establishments to request
prior approval from CBER for plasmapheresis of donors who do not meet
donor requirements. The information collection requirements for Sec.
606.110(b) are approved under OMB control number 0910-0338 and,
therefore, are not reflected in tables 1 and 2 of this document.
    Section 606.151(e) requires that SOPs for compatibility testing
include procedures to expedite transfusion in life-threatening
emergencies; records of all such incidents must be maintained,
including complete documentation justifying the emergency action, which
must be signed by a physician.
    So that each significant step in the collection, processing,
compatibility testing, storage, and distribution of each unit of blood
and blood components can be clearly traced, Sec.  606.160 requires that
legible and indelible contemporaneous records of each such step be made
and maintained for no less than 10 years. Section 606.160(b)(1)(viii))
requires records of the quarantine, notification, testing and
disposition performed under the HIV and HCV ``lookback'' provisions.
Furthermore, Sec.  606.160(b)(1)(ix) requires a blood collection
establishment to maintain records of notification of donors deferred or
determined not to be eligible for donation, including appropriate
followup. Section 606.160(b)(1)(xi) requires an establishment to
maintain records of notification of the referring physician of a
deferred autologous donor, including appropriate followup.
    Section 606.165, in brief, requires that distribution and receipt
records be maintained to facilitate recalls, if necessary.
    Section 606.170(a) requires records to be maintained of any reports
of complaints of adverse reactions arising as a result of blood
collection or transfusion. Each such report must be thoroughly
investigated, and a written report, including conclusions and followup,
must be prepared and maintained. When an investigation concludes that
the product caused the transfusion reaction, copies of all such written
reports must be forwarded to and maintained by the manufacturer or
collecting facility.
    Section 610.40(g)(1) (21 CFR 610.40(g)(1)) requires an
establishment to appropriately document a medical emergency for the
release of human blood or blood components prior to completion of
required testing.
    In addition to the CGMP regulations in part 606, there are
regulations in part 640 (21 CFR part 640) that require additional
standards for certain blood and blood components as follows: Sections
640.3(a)(1), (a)(2), and (f); 640.4(a)(1) and (a)(2); 640.25(b)(4) and
(c)(1); 640.27(b); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c);
640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3);
640.65(b)(2); 640.66; 640.71(b)(1); 640.72; 640.73; and 640.76(a) and
(b). The information collection requirements and estimated burdens for
these regulations are included in the part 606 burden estimates, as
described in tables 1 and 2 of this document.
    Respondents to this collection of information are licensed and
unlicensed blood establishments that collect blood and blood
components, including Source Plasma and Source Leukocytes, inspected by
FDA, and other transfusion services inspected by Centers for Medicare
and Medicaid Services (CMS). Based on information received from CBER's
database systems, there are approximately 81 licensed Source Plasma
establishments with multiple locations and approximately 2,000
registered blood collection establishments, for an estimated total of
2,081 establishments. Of these establishments, approximately 696
perform plateletpheresis and leukopheresis. These establishments
annually collect approximately 28 million units of Whole Blood and
blood components, including Source Plasma and Source Leukocytes, and
are required to follow FDA ``lookback'' procedures. In addition, there
are another 4,980 establishments that fall under the Clinical
Laboratory Improvement Amendments of 1988 (formerly referred to as
facilities approved for Medicare reimbursement) that transfuse blood
and blood components.
    The following reporting and recordkeeping estimates are based on
information provided by industry, CMS,

and FDA experience. Based on information received from industry, we
estimate that there are approximately 13 million donations of Source
Plasma from approximately 2 million donors and approximately 15 million
donations of Whole Blood, including approximately 300,000 (2 percent of
15 million) autologous donations, from approximately 8 million donors.
Assuming each autologous donor makes an average of 2 donations, FDA
estimates that there are approximately 150,000 autologous donors.
    FDA estimates that approximately 5 percent (12,000) of the 240,000
donations that are donated specifically for the use of an identified
recipient would be tested under the dedicated donors' testing
provisions in Sec.  610.40(c)(1)(ii).
    Under Sec.  610.40(g)(2) and (h)(2)(ii)(A), the only product
currently shipped prior to completion of testing for evidence of
certain communicable disease agents is a licensed product, Source
Leukocytes, used in the manufacture of interferon, which requires rapid
preparation from blood. Shipments of Source Leukocytes are pre-approved
under a biologics license application and each shipment does not have
to be reported to the agency. Based on information from CBER's database
system, FDA receives less than 1 application per year from
manufacturers of Source Leukocytes. However, for calculation purposes,
we are estimating 1 application annually.
    Under Sec.  610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), FDA estimates
that each manufacturer would ship an estimated 1 unit of human blood or
blood components per month (12 per year) that would require 2 labels;
one as reactive for the appropriate screening test under Sec.
610.40(h)(2)(ii)(C), and the other stating the exempted use
specifically approved by FDA under Sec.  610.40(h)(2)(ii)(D). According
to CBER's database system, there are approximately 40 licensed
manufacturers that ship known reactive human blood or blood components.
    Based on information we received from industry, we estimate that
approximately 18,000 donations: (1) Annually test reactive by a
screening test for syphilis, (2) are determined to be biological false
positives by additional testing, and (3) are labeled accordingly (Sec.
610.40(h)(2)(vi)).
    Human blood or a blood component with a reactive screening test, as
a component of a medical device, is an integral part of the medical
device, e.g., a positive control for an in vitro diagnostic testing
kit. It is usual and customary business practice for manufacturers to
include on the container label a warning statement that identifies the
communicable disease agent. In addition, on the rare occasion when a
human blood or blood component with a reactive screening test is the
only component available for a medical device that does not require a
reactive component, then a warning statement must be affixed to the
medical device. To account for this rare occasion under Sec.
610.42(a), we estimate that the warning statement would be necessary no
more than once a year.
    FDA estimates that approximately 3,500 repeat donors will test
reactive on a screening test for HIV. We also estimate that an average
of three components was made from each donation. Under Sec. Sec.
610.46(a)(1)(ii)(B) and 610.46(a)(3), this estimate results in 10,500
(3,500 x 3) notifications of the HIV screening test results to
consignees by collecting establishments for the purpose of quarantining
affected blood and blood components, and another 10,500 (3,500 x 3)
notifications to consignees of subsequent test results. We estimate an
average of 10 minutes per notification of consignees.
    Moreover, we estimate that Sec.  610.46(b)(3) will require 4,980
consignees to notify transfusion recipients, their legal
representatives, or physicians of record an average of 0.35 times per
year resulting in a total number of 1,755 (585 confirmed positive
repeat donors x 3) notifications. Under Sec.  610.46(b)(3), we also
estimate 1 hour to accommodate the time to gather test results and
records for each recipient and to accommodate multiple attempts to
contact the recipient.
    Furthermore, we estimate that approximately 7,800 repeat donors per
year would test reactive for antibody to HCV. Under Sec. Sec.
610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments would
notify the consignee 2 times for each of the 23,400 (7,800 x 3
components) components prepared from these donations, once for
quarantine purposes and again with additional HCV test results for a
total of 46,800 notifications as an annual ongoing burden. Under Sec.
610.47(b)(3), we estimate that approximately 4,980 consignees would
notify approximately 2,050 recipients or their physicians of record
annually. Finally, we estimate 1.0 hours to complete notification.
    Industry estimates that approximately 13 percent of 10 million
potential donors (1.3 million donors) who come to donate annually are
determined not to be eligible for donation prior to collection because
of failure to satisfy eligibility criteria. It is the usual and
customary business practice of approximately 2,000 blood collecting
establishments to notify onsite and to explain why the donor is
determined not to be suitable for donating. Based on such available
information, we estimate that two-thirds (1,333) of the 2,000 blood
collecting establishments provided onsite additional information and
counseling to a donor determined not to be eligible for donation as
usual and customary business practice. Consequently, we estimate that
only one-third, or 667, approximately, blood collecting establishments
would need to provide, under Sec.  630.6(a), additional information and
onsite counseling to the estimated 430,000 (one-third of approximately
1.3 million) ineligible donors.
    It is estimated that another 4.5 percent of 10 million potential
donors (450,000 donors) are deferred annually based on test results. We
estimate that currently approximately 95 percent of the establishments
that collect 99 percent of the blood and blood components notify donors
who have reactive test results for HIV, Hepatitis B Virus (HBV), HCV,
Human T-Lymphotropic Virus (HTLV), and syphilis as usual and customary
business practice. Consequently, 5 percent of the 2,081 establishments
(104) collecting 1 percent (4,500) of the deferred donors (450,000)
would notify donors under Sec.  630.6(a).
    As part of usual and customary business practice, collecting
establishments notify an autologous donor's referring physician of
reactive test results obtained during the donation process required
under Sec.  630.6(d)(1). However, we estimate that approximately 5
percent of the 2,000 blood collection establishments (100) may not
notify the referring physicians of the estimated 2 percent of 150,000
autologous donors with the initial reactive test results (3,000) as
their usual and customary business practice.
    The recordkeeping chart reflects the estimate that approximately 95
percent of the recordkeepers, which collect 99 percent of the blood
supply, have developed SOPs as part of their customary and usual
business practice. Establishments may minimize burdens associated with
CGMP and related regulations by using model standards developed by
industries' accreditation organizations. These accreditation
organizations represent almost all registered blood establishments.
    Under Sec.  606.160(b)(1)(ix), we estimate the total annual records
based on the approximately 1.3 million donors determined not to be
eligible to donate and each of the estimated 1.75 million (1.3 million
+ 450,000) donors deferred based on reactive test results for

evidence of infection because of communicable disease agents. Under
Sec.  606.160(b)(1)(xi), only the 2,000 registered blood establishments
collect autologous donations and, therefore, are required to notify
referring physicians. We estimate that 4.5 percent of the 150,000
autologous donors (6,750) will be deferred under Sec.  610.41, which in
turn will lead to the notification of their referring physicians.
    FDA has concluded that the use of untested or incompletely tested
but appropriately documented human blood or blood components in rare
medical emergencies should not be prohibited. We estimate the
recordkeeping under Sec.  610.40(g)(1) to be minimal with one or fewer
occurrences per year. The reporting of test results to the consignee in
Sec.  610.40(g) does not create a new burden for respondents because it
is the usual and customary business practice or procedure to finish the
testing and provide the results to the manufacturer responsible for
labeling the blood products.
    The hours per response and hours per record are based on estimates
received from industry or FDA experience with similar recordkeeping or
reporting requirements.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                        No. of         Annual Frequency       Total Annual       Hours per
 21 CFR Section      Respondents         per Response          Responses          Response        Total Hours
----------------------------------------------------------------------------------------------------------------
606.170(a)                   353\5\                  1.20                424              0.5                212
----------------------------------------------------------------------------------------------------------------
606.170(b)\2\                   100                     1                100               20              2,000
----------------------------------------------------------------------------------------------------------------
610.40(c)(1)(ii)              2,081                  5.77             12,000             0.08                960
----------------------------------------------------------------------------------------------------------------
610.40(g)(2)                      1                     1                  1                1                  1
----------------------------------------------------------------------------------------------------------------
610.40(h)(2)(ii)                  1                     1                  1                1                  1
 (A)
----------------------------------------------------------------------------------------------------------------
610.40(h)(2)(ii)                 40                    12                480              0.2                 96
 (C) and
 (h)(2)(ii)(D)
----------------------------------------------------------------------------------------------------------------
610.40(h)(2)(vi)              2,081                  8.65             18,000             0.08              1,440
----------------------------------------------------------------------------------------------------------------
610.42(a)                         1                     1                  1                1                  1
----------------------------------------------------------------------------------------------------------------
610.46(a)(1)(ii)              2,000                  5.25             10,500             0.17              1,785
 (B)
----------------------------------------------------------------------------------------------------------------
610.46(a)(3)                  2,000                  5.25             10,500             0.17              1,785
----------------------------------------------------------------------------------------------------------------
610.47(b)(3)                  4,980                  0.41              2,050              1.0              2,050
----------------------------------------------------------------------------------------------------------------
610.47(a)(1)(ii)              2,000                 11.70             23,400             0.17              3,978
 (B)
----------------------------------------------------------------------------------------------------------------
610.47(a)(3)                  2,000                 11.70             23,400             0.17              3,978
----------------------------------------------------------------------------------------------------------------
610.47(b)(3)                  4,980                  0.41              2,050              1.0              2,050
----------------------------------------------------------------------------------------------------------------
630.6(a)\3\                     667                644.68            430,000             0.08             34,400
----------------------------------------------------------------------------------------------------------------
630.6(a)\4\                     104                 43.27              4,500              1.5              6,750
----------------------------------------------------------------------------------------------------------------
630.6(d)(1)                     100                    30              3,000                1              3,000
----------------------------------------------------------------------------------------------------------------
Total                                                                                64,487
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\The reporting requirement in Sec.   640.73, which addresses the reporting of fatal donor reactions, is
  included in the estimate for Sec.   606.170(b).
\3\Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility
  criteria.
\4\Notification of donors deferred based on reactive test results for evidence of infection due to communicable
  disease agents.
\5\Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that
  transfuse blood and components and FDA-registered blood establishments (0.05 x 4,980 + 2,081).

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual
  21 CFR Section     Recordkeepers    per Recordkeeping       Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
606.100(b)\2\                 353\5\                  1                353                 24              8,472
----------------------------------------------------------------------------------------------------------------
606.100(c)                    353\5\                 10              3,530                  1              3,530
----------------------------------------------------------------------------------------------------------------
606.110(a)\3\                  35\6\                  1                 35                0.5                 18
----------------------------------------------------------------------------------------------------------------
606.151(e)                    353\5\                 12              4,236              0.083                352
----------------------------------------------------------------------------------------------------------------
606.160\4\                    353\5\             793.20            280,000               0.75            210,000
----------------------------------------------------------------------------------------------------------------

606.160(b)(1)(viii)
----------------------------------------------------------------------------------------------------------------
  HIV consignee                2,000              10.50             21,000                .17              3,570
   notification
                  ----------------------------------------------------------------------------------------------
                               4,980               4.21             21,000                .17              3,570
----------------------------------------------------------------------------------------------------------------
  HCV consignee                2,000              23.40             46,800                .17              7,956
   notification
                  ----------------------------------------------------------------------------------------------
                               4,980                9.4             46,800                .17              7,956
----------------------------------------------------------------------------------------------------------------
  HIV recipient                4,980               0.35              1,755                .17                298
   notification
----------------------------------------------------------------------------------------------------------------
  HCV recipient                4,980               0.41              2,050                .17                349
   notification
----------------------------------------------------------------------------------------------------------------
606.160(b)(1)(ix)              2,081             840.94          1,750,000               0.05            875,000
----------------------------------------------------------------------------------------------------------------
606.160(b)(1)(xi)              2,000              3.375              6,750               0.05                338
----------------------------------------------------------------------------------------------------------------
606.165                       353\5\             793.20            280,000              0.083             23,240
----------------------------------------------------------------------------------------------------------------
606.170(a)                    353\5\                 12              4,236               1.00              4,236
----------------------------------------------------------------------------------------------------------------
610.40(g)(1)                   2,081                  1              2,081               0.50              1,041
----------------------------------------------------------------------------------------------------------------
Total                                                                                1,149,926
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\The recordkeeping requirements in Sec.  Sec.   640.3(a)(1), 640.4(a)(1), and 640.66, which address the
  maintenance of SOPs, are included in the estimate for Sec.   606.100(b).
\3\The recordkeeping requirements in Sec.   640.27(b), which address the maintenance of donor health records for
  the plateletpheresis, are included in the estimate for Sec.   606.110(a).
\4\The recordkeeping requirements in Sec.  Sec.   640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1);
  640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2);
  640.71(b)(1); 640.72; and 640.76(a) and (b), which address the maintenance of various records are included in
  the estimate for Sec.   606.160.
\5\Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that
  transfuse blood and components and FDA-registered blood establishments (0.05 x 4,980 + 2,081).
\6\Five percent of plateletpheresis and leukopheresis establishments (0.05 x 696).

    Dated: June 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14248 Filed 6-23-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 72958-72959]
[FR Doc No: 2015-29755]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

------------------------------------------------------------------------
                                                        Presenter or
            Docket No.                 File date          requester
------------------------------------------------------------------------
Prohibited:
    1. CP15-554-000...............       11-2-2015  Mary Louise Fisher.
    2. CP14-554-000, CP15-16-000,       11-13-2015  Susan VanBrunt.
     CP15-17-000.
    3. EL15-18-000, EL15-67-000...      11-17-2015  FERC Staff.\1\
Exempt:
    1. P-1256-000.................      10-29-2015  FERC Staff.\2\
    2. CP15-517-000...............      10-29-2015  FERC Staff.\3\
    3. CP15-138-000...............      10-29-2015  US Representative
                                                     Lou Barletta.
    4. P-1256-031.................      10-30-2015  US Senators.\4\
    5. CP14-96-000................       11-4-2015  State of New York
                                                     Assemblywoman Sandy
                                                     Galef.
    6. CP15-521-000...............       11-5-2015  FERC Staff.\5\
    7. CP15-517-000...............       11-5-2015  FERC Staff.\6\
    8. CP13-492-000...............       11-5-2015  FERC Staff.\7\
    9. CP15-554-000...............       11-9-2015  State of Virginia
                                                     Senator R. Creigh
                                                     Deeds.
    10. CP15-555-000..............      11-10-2015  US Representative
                                                     Charles W. Dent.
------------------------------------------------------------------------
\1\ Email dated November 17, 2015 forwarding letter from Linden VFT,
  LLC.
\2\ Email dated October 23, 2015.
\3\ Minutes from October 22, 2015 conference call between FERC, ICF,
  Gulf South, and Perennial regarding Coastal Bend Header Project.
\4\ Ben Sasse and Deb Fischer.
\5\ Meeting Summary from October 29, 2015 call with applicant and
  agencies regarding Gulf LNG Liquefaction Project.
\6\ Phone Memorandum dated November 4, 2015 with Arturo Vale (US Fish
  and Wildlife Service).
\7\ Memo forwarding letter dated October 29, 2015 from US Bureau of
  Reclamation.

    Dated: November 17, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-29755 Filed 11-20-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Rules and Regulations]
[Pages 51876-51878]
[FR Doc No: 2011-21195]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2011-M-0570]

Medical Devices; Ophthalmic Devices; Classification of the Eyelid
Thermal Pulsation System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the
eyelid thermal pulsation system into class II (special controls). The
Agency is classifying the device into class II (special controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.

DATES: This rule is effective September 19, 2011. The classification
was effective on June 28, 2011.

FOR FURTHER INFORMATION CONTACT: Marc Robboy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2256, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not
in commercial distribution before May 28, 1976 (the date of enactment
of the Medical Device Amendments of 1976), generally referred to as
postamendments devices, are classified automatically by statute into
class III without any FDA rulemaking process. These devices remain in
class III and require premarket approval, unless and until the device
is classified or reclassified into class I or II, or FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i) of the FD&C Act (21 U.S.C. 360c(i)), to a predicate
device that does not require premarket approval. The Agency determines
whether new devices are substantially equivalent to predicate devices
by means of premarket notification procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR
part 807).
    Section 513(f)(2) of the FD&C Act provides that any person who
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified may, within 30
days after receiving an order classifying the device into class III
under section 513(f)(1) of the FD&C Act, request FDA to classify the
device under the criteria set forth in section 513(a)(1) of the FD&C
Act. FDA will, within 60 days of receiving this request, classify the
device by written order. This classification will be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on July 12, 2010, classifying the LipiFlow[supreg] Thermal
Pulsation System into class III, because it was not substantially
equivalent to a device that was introduced or delivered for
introduction into interstate commerce for commercial distribution
before May 28, 1976, or a device which was subsequently reclassified
into class I or class II. On August 6, 2010, TearScience, Inc.,
submitted a petition requesting classification of the LipiFlow[supreg]
Thermal Pulsation System under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II.
(Ref. 1)
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the petition in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls will provide reasonable
assurance of the safety and effectiveness of the device.
    The device is assigned the generic name eyelid thermal pulsation
system, and it is identified as an electrically-powered device intended
for use in the application of localized heat and pressure therapy to
the eyelids. The device is used in adult patients with chronic cystic
conditions of the eyelids,

including meibomian gland dysfunction (MGD), also known as evaporative
dry eye or lipid deficiency dry eye. The system consists of a component
that is inserted around the eyelids and a component to control the
application of heat and pressure to the eyelids.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks:

------------------------------------------------------------------------
              Identified risk                    Mitigation measures
------------------------------------------------------------------------
Infection.................................  Sterility and Shelf Life
                                             Testing.
Adverse tissue reaction...................  Biocompatibility.
Electrical shock..........................  Electrical Safety Testing.
Electromagnetic interference..............  Electromagnetic
                                             Compatibility (EMC)
                                             Testing; Labeling.
Thermal damage............................  Temperature Performance
                                             Testing.
Mechanical damage.........................  Pressure Performance
                                             Testing.
Malfunction...............................  Non-clinical and Clinical
                                             Performance Testing.
User error................................  Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls can address these
risks to health and provide reasonable assurance of safety and
effectiveness: (1) Appropriate analysis/testing should validate
electromagnetic compatibility (EMC) and safety of exposure to non-
ionizing radiation; (2) Design, description, and performance data
should validate safeguards related to the temperature and pressure
aspects of the device, including during fault conditions; (3)
Performance data should demonstrate the sterility of patient-contacting
components and the shelf-life of these components; (4) The device
should be demonstrated to be biocompatible; and (5) Performance data
should demonstrate that any technological changes do not adversely
affect safety and effectiveness. Therefore, on June 28, 2011, FDA
issued an order to the petitioner classifying the device into class II.
FDA is codifying the classification of the device by adding Sec.
886.5200.
    Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for an eyelid thermal
pulsation system will need to comply with the special controls named in
the regulation.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the eyelid thermal pulsation system
they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that 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.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of this device from class
III to class II will relieve manufacturers of the device of the cost of
complying with the premarket approval requirements of section 515 of
the FD&C act (21 U.S.C. 360e), and may permit small potential
competitors to enter the marketplace by lowering their costs, the
Agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain state requirements ``different from or in
addition to'' certain Federal requirements applicable to devices. (See
section 521 of the FD&C Act (21 U.S.C. 360k) Medtronic Inc., v. Lohr,
518 U.S. 470 (1996); Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008)).
The special controls established by this final rule create
``requirements'' for specific medical devices under 21 U.S.C. 360k,
even though product sponsors have some flexibility in how they meet
those requirements. See Papike v. Tambrands, Inc., 107 F. 3d 737, 740-
42 (9th Cir. 1997).

V. Paperwork Reduction Act of 1995

    This final rule establishes special controls that refer to
currently approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 32501-3520). The collections of information in
21 CFR part 807, supbart E, have been approved under OMB control number
0910-0120; the collections of information in 21 CFR part 801 have been
approved under OMB control number 0910-0485.

VI. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons

between 9 a.m. and 4 p.m., Monday through Friday.

1. Petition from TearScience, Inc., August 6, 2010.

List of Subjects in 21 CFR Part 886

    Medical devices.

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

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for 21 CFR part 886 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 886.5200 is added to subpart F to read as follows:

Sec.  886.5200  Eyelid thermal pulsation system.

    (a) Identification. An eyelid thermal pulsation system is an
electrically-powered device intended for use in the application of
localized heat and pressure therapy to the eyelids. The device is used
in adult patients with chronic cystic conditions of the eyelids,
including meibomian gland dysfunction (MGD), also known as evaporative
dry eye or lipid deficiency dry eye. The system consists of a component
that is inserted around the eyelids and a component to control the
application of heat and pressure to the eyelids.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Appropriate analysis/testing should validate electromagnetic
compatibility (EMC) and safety of exposure to non-ionizing radiation;
    (2) Design, description, and performance data should validate
safeguards related to the temperature and pressure aspects of the
device, including during fault conditions;
    (3) Performance data should demonstrate the sterility of patient-
contacting components and the shelf-life of these components;
    (4) The device should be demonstrated to be biocompatible; and
    (5) Performance data should demonstrate that any technological
changes do not adversely effect safety and effectiveness.

    Dated: August 12, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-21195 Filed 8-18-11; 8:45 am]
BILLING CODE 4160-01-P


To:	Ken Feith

From:	Elliott H. Berger and Brian Myers

Date:	January 24, 2007

Re:	Observations regarding key issues reviewed at EPA’s informal HPD
meeting

The following captures our understanding of, and opinions regarding, the
key issues discussed at the recent informal HPD meeting held by EPA in
Ariel Rios North on January 24, 2007.

Although we don’t have a preference for Method A or B, we do strongly
feel that only one Method be selected and required by the EPA.  It will
be too time consuming and too costly to require that companies test by
both methods.  Likewise, we prefer that the choice be from one of the
ANSI S12.6 procedures, either A or B, with reasonable modifications from
EPA, and / or the upcoming efforts of S12/WG11 to revise S12.6.

With respect to the A vs. B decision, perhaps the most important
consideration is that the labeled value, or if two values or a range are
chosen, the lower of the labeled values,  can be applied to occupational
HCPs without the need for derating by OSHA or otherwise.

We support the concept that retesting for a product can occur in the
same or a different lab at the manufacturer’s option and that
compliance audit testing take place in the same lab with an EPA witness
if possible.  As for the frequency of retesting (in the absence of any
suspicion that the product has changed or has been mislabeled), we
suggest that 7 years is the appropriate time frame that provides the
best compromise between concern for product changes and recognition of
the cost and time required for retesting.

The primary label for the packaging should include in the upper panel
the words Noise Reduction Statistic (alternately the Noise Reduction
Range) and in the upper part of the top section contain a horizontal bar
that extends from the 80 percentile at the left end to the 20th
percentile at the right end.  Indicate that this is the NRS or NRR in
decibels and that the left-end lower number indicates the value
“possible for most users to achieve” (if Method-B data are used), or
the value “possible for most individually trained users to achieve”
(for Method-A data).  The right-end upper value should be labeled as
“possible for a few proficient users to achieve,” and these words
are suitable for either Method-A or B data.

The middle part of the panel should use the following wording from the
Berger/Gauger paper:

For existing products the range of Noise Reduction Statistics is about 0
- 30 for the Low Value, and 20 - 40 for the High Value.  Larger values,
and a smaller range between the Low and High Value, denote greater
effectiveness and reliability.  Contact the manufacturer or see the
Secondary Label for additional guidance.

The preceding applies to most HPDs.  However, for ANR devices
specifically targeted towards aviation environments a suitable graphic
should replace the bar and the user will be directed towards the
accompanying information for guidance.  Likewise an icon for impulsive
noise/gunfire should be used in place of the bar also with guidance to
look elsewhere for information for level-dependent devices.

The regulation should be more clear about the fact that for products
like the E(A(R Classic® that is sold in a pillow pack, but normally
dispensed from a large box of 200 or more pairs, that the primary label
need not appear on the individual package, since in fact the package is
smaller than the label.  This is inferred in the current document, but
not explicit.

With respect to the secondary and perhaps tertiary labels that will
include instructions, how to use the NRR, and other ancillary
information, these label(s) should NOT be required to be on the box or
even in the box.  We don’t have room on the box now because of the
many languages we have to incorporate, and putting it in the box is
costly and a waste of paper.  The regulation should require that the
information be readily available by calling an 800 number for a fax, or
visiting a web site, and the labeling may also include reference to the
EPA/NIOSH repository web site (see next item).

We support the idea of a NIOSH-developed NRR calculator into which
manufacturers can upload their data to create a Hearing Protector Data
Sheet (HPDS).  We would like to work with NIOSH to make sure that the
categories selected to distinguish types of hearing protectors are the
most useful to our customers.

EPA should build flexibility into the regulation so that it can easily
be updated to reflect any changes that occur in the future in the
relevant ANSI standards that are cited.

The test procedures for ANR muffs should provide the user only the total
attenuation.  It is not needed to provide the passive and active
components separately to the end user, though those are required by the
lab in the intermediate computations.  The procedure that should be
cited for the combination of MIRE and REAT test data is the footnote
that is included in the draft S12.68 standard that discusses this issue.

During the meeting, Berger proposed the following summary of the pros
and cons of Methods A and B, and it generally received a favorable
response.

Overview of preferred Method with respect to eleven different
considerations

Issue	Method A	Method B	Either

Within-lab variability is smaller	(

Between-lab variability is smaller

(

	Cost of testing is less	(

Speed with which tests can be conducted	(

Provides realistic estimate of magnitude of field attenuation

(

	Provides best estimate of rank ordering of field attenuation

(

	No derating needed

(

	“Justifiable” and/or understandable to typical person	(

Can be used with dual number-rating system

	(

Provides best estimate of device’s inherent performance	(

Compatible with international standards and regulations

	(

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files\regulatory\epa jan 07 workshop followup.doc

Observations regarding informal HPD meeting		Page -   PAGE  2