82_FR_61549 82 FR 61302 - Agency Information Collection Activities; Submission for OMB Review; Comment Request

82 FR 61302 - Agency Information Collection Activities; Submission for OMB Review; Comment Request

FEDERAL TRADE COMMISSION

Federal Register Volume 82, Issue 247 (December 27, 2017)

Page Range61302-61304
FR Document2017-27868

In compliance with the Paperwork Reduction Act (PRA) of 1995, the FTC is seeking public comments on its request to OMB for a three- year extension of the current PRA clearance for information collection requirements contained in its Trade Regulation Rule entitled Labeling and Advertising of Home Insulation (R-value Rule or Rule). That clearance expires on January 31, 2018.

Federal Register, Volume 82 Issue 247 (Wednesday, December 27, 2017)
[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Notices]
[Pages 61302-61304]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27868]


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FEDERAL TRADE COMMISSION


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Federal Trade Commission (``FTC'').

ACTION: Notice and request for comment.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) of 1995, 
the FTC is seeking public comments on its request to OMB for a three-
year extension of the current PRA clearance for information collection 
requirements contained in its Trade Regulation Rule entitled Labeling 
and Advertising of Home Insulation (R-value Rule or Rule). That 
clearance expires on January 31, 2018.

DATES: Comments must be received by January 26, 2018.

ADDRESSES: Interested parties may file a comment online or on paper by 
following the instructions in the Request for Comments part of the 
SUPPLEMENTARY INFORMATION section below. Write ``R-value Rule: FTC File 
No. R811001'' on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/rvaluerulepra2 by following the 
instructions on the web-based form. If you prefer to file your comment 
on paper, mail your comment to the following address: Federal Trade 
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite 
CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex 
J), Washington, DC 20024.

[[Page 61303]]


FOR FURTHER INFORMATION CONTACT: Requests for additional information or 
copies of the proposed information requirements should be addressed to 
Hampton Newsome, Attorney, Division of Enforcement, Bureau of Consumer 
Protection, Federal Trade Commission, Mail Code CC-9528, 600 
Pennsylvania Ave. NW, Washington, DC 20580, (202) 326-2889.

SUPPLEMENTARY INFORMATION: 
    Title: R-value Rule, 16 CFR part 460.
    OMB Control Number: 3084-0109.
    Type of Review: Extension of a currently approved collection.
    Abstract: The R-value Rule establishes uniform standards for the 
substantiation and disclosure of accurate, material product information 
about the thermal performance characteristics of home insulation 
products. The R-value of an insulation signifies the insulation's 
degree of resistance to the flow of heat. This information tells 
consumers how well a product is likely to perform as an insulator and 
allows consumers to determine whether the cost of the insulation is 
justified.
    On October 11, 2017, the Commission sought comment on the 
information collection requirements in the R-value Rule. 82 FR 47207. 
No germane comments were received. As required by OMB regulations, 5 
CFR part 1320, the FTC is providing this second opportunity for public 
comment. Comments should address only the information collection 
requirements of the current Rule. They should not address proposed Rule 
amendments recently announced by the Commission in a separate 
proceeding.\1\
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    \1\ See, ``FTC Proposes Updates to R-Value Rule for Home 
Insulation Products,'' Dec. 4, 2017, https://www.ftc.gov/news-events/press-releases/2017/12/ftc-proposes-updates-r-value-rule-home-insulation-products.
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    Estimated Annual Hours Burden: 131,740 hours.
    Likely Respondents and Estimated Burden:
    Installation manufacturers, installers, new home builders/sellers, 
dealers and retailers.
    (a) Installation manufacturers.
     Testing by installation manufacturers - 15 new products/
year x 2 hours each = 30 hours; and
     Disclosures by installation manufacturers - [(144 
manufacturers x 20 hours) + (6 largest manufacturers x 80 hours each] = 
3,360 hours.
     Recordkeeping by installation manufacturers - 150 
manufacturers x 1 hour each = 150 hours.
    (b) Installers.
     Disclosures by retrofit installers (manufacturer's 
insulation fact sheet) - 2 million retrofit installations/year x 2 
minutes each = 66,667 hours.
     Disclosures by installers (advertising) - 1,615 installers 
x 1 hour each = 1,615 hours.
     Recordkeeping by installers - 1,615 installers x 5 minutes 
each = 135 hours.
    (c) New home builders/sellers, dealers.
     Disclosures by new home sellers - 1,174,000 new home 
sales/year x 30 seconds each = 9,783 hours.
    (d) Retailers.
     Disclosures by retailers - [25,000 retailers x 1 hour each 
(fact sheets) + 25,000 retailers x 1 hour each (advertising disclosure) 
= 50,000 hours.
    Frequency of Response: Periodic.
    Total Annual Labor Cost: $2,616,943 per year (solely related to 
labor costs) [approximately $858 for testing, based on 30 hours for 
manufacturers (30 hours x $28.61 per hour for skilled technical 
personnel); $4,284 for manufacturers' and installers' compliance with 
the Rule's recordkeeping requirements, based on 285 hours (285 hours x 
$15.03 per hour for clerical personnel); $50,501 for manufacturers' 
compliance with third-party disclosure requirements, based on 3,360 
hours (3,360 hours x $15.03 per hour for clerical personnel); and 
$2,561,300 for disclosure compliance by installers, new home sellers, 
and retailers (128,065 hours x $20 per hour for sales persons).]

Request for Comment

    You can file a comment online or on paper. For the FTC to consider 
your comment, we must receive it on or before January 26, 2018. Write 
``R-value Rule: FTC File No. R811001'' on your comment. Your comment--
including your name and your state--will be placed on the public record 
of this proceeding, including, to the extent practicable, on the public 
Commission website, at http://www.ftc.gov/os/publiccomments.shtm. As a 
matter of discretion, the Commission tries to remove individuals' home 
contact information from comments before placing them on the Commission 
website.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comments online, or to send them to the Commission by courier or 
overnight service. To make sure that the Commission considers your 
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/rvaluerulepra2 by following the instructions on the web-based form. 
When this Notice appears at http://www.regulations.gov, you also may 
file a comment through that website.
    If you file your comment on paper, write ``R-value Rule: FTC File 
No. R811001'' on your comment and on the envelope, and mail it to the 
following address: Federal Trade Commission, Office of the Secretary, 
600 Pennsylvania Avenue NW, Suite CC-5610 (Annex J), Washington, DC 
20580, or deliver your comment to the following address: Federal Trade 
Commission, Office of the Secretary, Constitution Center, 400 7th 
Street SW, 5th Floor, Suite 5610, Washington, DC 20024. If possible, 
submit your paper comment to the Commission by courier or overnight 
service.
    Comments on the information collection requirements subject to 
review under the PRA should additionally be submitted to OMB. If sent 
by U.S. mail, they should be addressed to Office of Information and 
Regulatory Affairs, Office of Management and Budget, Attention: Desk 
Officer for the Federal Trade Commission, New Executive Office 
Building, Docket Library, Room 10102, 725 17th Street NW, Washington, 
DC 20503. Comments sent to OMB by U.S. postal mail are subject to 
delays due to heightened security precautions. Thus, comments can also 
be sent via email to [email protected].
    Because your comment will be placed on the publicly accessible FTC 
website at https://www.ftc.gov, you are solely responsible for making 
sure that your comment does not include any sensitive or confidential 
information. In particular, your comment should not include any 
sensitive personal information, such as your or anyone else's Social 
Security number; date of birth; driver's license number or other state 
identification number, or foreign country equivalent; passport number; 
financial account number; or credit or debit card number. You are also 
solely responsible for making sure that your comment does not include 
any sensitive health information, such as medical records or other 
individually identifiable health information. In addition, your comment 
should not include any ``trade secret or any commercial or financial 
information which . . . is privileged or confidential'' --as provided 
by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 
4.10(a)(2), 16 CFR 4.10(a)(2)--including in particular competitively 
sensitive information such as costs, sales statistics, inventories, 
formulas, patterns, devices, manufacturing processes, or customer 
names.
    Comments containing material for which confidential treatment is

[[Page 61304]]

requested must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request, and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted on the public FTC website--as legally required by FTC Rule 
4.9(b)--we cannot redact or remove your comment from the FTC website, 
unless you submit a confidentiality request that meets the requirements 
for such treatment under FTC Rule 4.9(c), and the General Counsel 
grants that request.
    The FTC Act and other laws that the Commission administers permit 
the collection of public comments to consider and use in this 
proceeding as appropriate. The Commission will consider all timely and 
responsive public comments that it receives on or before January 26, 
2018. For information on the Commission's privacy policy, including 
routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

David C. Shonka,
Acting General Counsel.
[FR Doc. 2017-27868 Filed 12-26-17; 8:45 am]
 BILLING CODE 6750-01-P



                                               61302                    Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Notices

                                               of the Transaction include ten local                    their competitors respond to their own                such time as the buyer (or buyers) no
                                               markets within the following cities:                    prices.                                               longer requires transitional assistance,
                                               Aitkin, Hibbing, Minnetonka, Mora,                         Entry into each relevant market would              the Order to Maintain Assets authorizes
                                               Saint Paul, and Saint Peter in                          not be timely, likely, or sufficient to               the Commission to appoint an
                                               Minnesota, and Hayward, Siren, and                      deter or counteract the anticompetitive               independent third party as a Monitor to
                                               Spooner in Wisconsin.                                   effects arising from the Acquisition.                 oversee the Respondents’ compliance
                                                  The geographic markets for retail                    Significant entry barriers include the                with the requirements of the proposed
                                               gasoline and retail diesel are highly                   availability of attractive real estate, the           Consent Agreement.
                                               localized, ranging up to a few miles,                   time and cost associated with                           The purpose of this analysis is to
                                               depending on local circumstances. Each                  constructing a new retail fuel outlet, and            facilitate public comment on the
                                               relevant market is distinct and fact-                   the time associated with obtaining                    proposed Consent agreement, and the
                                               dependent, reflecting the commuting                     necessary permits and approvals.                      Commission does not intend this
                                               patterns, traffic flows, and outlet                                                                           analysis to constitute an official
                                                                                                       V. The Proposed Consent Agreement
                                               characteristics unique to each market.                                                                        interpretation of the proposed Consent
                                               Consumers typically choose between                         The proposed Consent Agreement                     Agreement or to modify its terms in any
                                               nearby retail fuel outlets with similar                 would remedy the Acquisition’s likely                 way.
                                                                                                       anticompetitive effects by requiring
                                               characteristics along their planned                                                                             By direction of the Commission.
                                                                                                       ACT and CAPL to divest certain CAPL
                                               routes. The geographic markets for the                                                                        Donald S. Clark,
                                                                                                       and Holiday retail fuel outlets and
                                               retail sale of diesel may be similar to the                                                                   Secretary.
                                                                                                       related assets in ten local markets.
                                               corresponding geographic markets for                       The proposed Consent Agreement                     [FR Doc. 2017–27924 Filed 12–26–17; 8:45 am]
                                               retail gasoline as many diesel                          requires that the divestiture occur no                BILLING CODE 6750–01–P
                                               consumers exhibit the same preferences                  later than 120 days after ACT
                                               and behaviors as gasoline consumers.                    consummates the Acquisition. This
                                                  The Transaction would substantially                  Agreement protects the Commission’s                   FEDERAL TRADE COMMISSION
                                               increase the market concentration in                    ability to obtain complete and effective
                                               each of the ten local markets, resulting                relief given the small number of outlets              Agency Information Collection
                                               in highly concentrated markets. In five                                                                       Activities; Submission for OMB
                                                                                                       to be divested. Further, based on
                                               local markets, the Transaction would                                                                          Review; Comment Request
                                                                                                       Commission staff’s investigation, the
                                               reduce the number of competitively                      Commission believes that ACT can                      AGENCY:    Federal Trade Commission
                                               constraining independent market                         identify an acceptable buyer (or buyers)              (‘‘FTC’’).
                                               participants from three to two. In the                  within 120 days.                                      ACTION: Notice and request for comment.
                                               remaining five local markets, the                          The proposed Consent Agreement
                                               Transaction would reduce the number                     further requires ACT and CAPL to                      SUMMARY:   In compliance with the
                                               of competitively constraining                           maintain the economic viability,                      Paperwork Reduction Act (PRA) of
                                               independent market participants from                    marketability, and competitiveness of                 1995, the FTC is seeking public
                                               four to three.                                          each divestiture asset until the                      comments on its request to OMB for a
                                                  The Transaction would substantially                  Commission approves a buyer (or                       three-year extension of the current PRA
                                               lessen competition for the retail sale of               buyers) and the divestiture is complete.              clearance for information collection
                                               gasoline and the retail sale of diesel in               For up to twelve months following the                 requirements contained in its Trade
                                               these local markets. Retail fuel outlets                divestiture, ACT and CAPL must make                   Regulation Rule entitled Labeling and
                                               compete on price, store format, product                 available transitional services, as                   Advertising of Home Insulation (R-value
                                               offerings, and location, and pay close                  needed, to assist the buyer of each                   Rule or Rule). That clearance expires on
                                               attention to competitors in close                       divestiture asset.                                    January 31, 2018.
                                               proximity, on similar traffic flows, and                   In addition to requiring outlet                    DATES: Comments must be received by
                                               with similar store characteristics. The                 divestitures, the proposed Consent                    January 26, 2018.
                                               combined entity would be able to raise                  Agreement also requires ACT and CAPL                  ADDRESSES: Interested parties may file a
                                               prices unilaterally in markets where                    to provide the Commission notice before               comment online or on paper by
                                               ACT and Holiday are close competitors.                  acquiring designated outlets in the ten               following the instructions in the
                                               Absent the Transaction, ACT and                         local areas for ten years. The prior                  Request for Comments part of the
                                               Holiday would continue to compete                       notice provision is necessary because                 SUPPLEMENTARY INFORMATION section
                                               head to head in these local markets.                    acquisitions of the designated outlets                below. Write ‘‘R-value Rule: FTC File
                                                  Moreover, the Transaction would                      likely raise competitive concerns and                 No. R811001’’ on your comment, and
                                               increase the likelihood of coordination                 may fall below the HSR Act premerger                  file your comment online at https://
                                               in local markets where only two or three                notification thresholds.                              ftcpublic.commentworks.com/ftc/
                                               competitively constraining independent                     The proposed Consent Agreement                     rvaluerulepra2 by following the
                                               market participants would remain. Two                   contains additional provisions designed               instructions on the web-based form. If
                                               aspects of the retail fuel industry make                to ensure the effectiveness of the                    you prefer to file your comment on
                                               it vulnerable to coordination. First,                   proposed relief. For example,                         paper, mail your comment to the
                                               retail fuel outlets post their fuel prices              Respondents have agreed to an Order to                following address: Federal Trade
                                               on price signs that are visible from the                Maintain Assets that will issue at the                Commission, Office of the Secretary,
                                               street, allowing competitors to observe                 time the proposed Consent Agreement is                600 Pennsylvania Avenue NW, Suite
daltland on DSKBBV9HB2PROD with NOTICES




                                               each other’s fuel prices without                        accepted for public comment. The Order                CC–5610 (Annex J), Washington, DC
                                               difficulty. Second, retail fuel outlets                 to Maintain Assets requires                           20580, or deliver your comment to the
                                               regularly track their competitors’ fuel                 Respondents to operate and maintain                   following address: Federal Trade
                                               prices and change their own prices in                   each divestiture outlet in the normal                 Commission, Office of the Secretary,
                                               response. These repeated interactions                   course of business, through the date the              Constitution Center, 400 7th Street SW,
                                               give retail fuel outlets familiarity with               Respondents’ complete divestiture of                  5th Floor, Suite 5610 (Annex J),
                                               how their competitors price and how                     the outlet. During this period, and until             Washington, DC 20024.


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                                                                        Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Notices                                          61303

                                               FOR FURTHER INFORMATION CONTACT:                        2 million retrofit installations/year × 2             www.regulations.gov, you also may file
                                               Requests for additional information or                  minutes each = 66,667 hours.                          a comment through that website.
                                               copies of the proposed information                        • Disclosures by installers                            If you file your comment on paper,
                                               requirements should be addressed to                     (advertising) ¥ 1,615 installers × 1 hour             write ‘‘R-value Rule: FTC File No.
                                               Hampton Newsome, Attorney, Division                     each = 1,615 hours.                                   R811001’’ on your comment and on the
                                               of Enforcement, Bureau of Consumer                        • Recordkeeping by installers ¥                     envelope, and mail it to the following
                                               Protection, Federal Trade Commission,                   1,615 installers × 5 minutes each = 135               address: Federal Trade Commission,
                                               Mail Code CC–9528, 600 Pennsylvania                     hours.                                                Office of the Secretary, 600
                                               Ave. NW, Washington, DC 20580, (202)                      (c) New home builders/sellers,                      Pennsylvania Avenue NW, Suite CC–
                                               326–2889.                                               dealers.                                              5610 (Annex J), Washington, DC 20580,
                                                                                                         • Disclosures by new home sellers ¥                 or deliver your comment to the
                                               SUPPLEMENTARY INFORMATION:
                                                                                                       1,174,000 new home sales/year × 30                    following address: Federal Trade
                                                 Title: R-value Rule, 16 CFR part 460.
                                                                                                       seconds each = 9,783 hours.                           Commission, Office of the Secretary,
                                                 OMB Control Number: 3084–0109.
                                                                                                         (d) Retailers.                                      Constitution Center, 400 7th Street SW,
                                                 Type of Review: Extension of a                          • Disclosures by retailers ¥ [25,000
                                               currently approved collection.                                                                                5th Floor, Suite 5610, Washington, DC
                                                                                                       retailers × 1 hour each (fact sheets) +               20024. If possible, submit your paper
                                                 Abstract: The R-value Rule establishes                25,000 retailers × 1 hour each
                                               uniform standards for the substantiation                                                                      comment to the Commission by courier
                                                                                                       (advertising disclosure) = 50,000 hours.              or overnight service.
                                               and disclosure of accurate, material                      Frequency of Response: Periodic.                       Comments on the information
                                               product information about the thermal                     Total Annual Labor Cost: $2,616,943                 collection requirements subject to
                                               performance characteristics of home                     per year (solely related to labor costs)              review under the PRA should
                                               insulation products. The R-value of an                  [approximately $858 for testing, based                additionally be submitted to OMB. If
                                               insulation signifies the insulation’s                   on 30 hours for manufacturers (30 hours               sent by U.S. mail, they should be
                                               degree of resistance to the flow of heat.               × $28.61 per hour for skilled technical               addressed to Office of Information and
                                               This information tells consumers how                    personnel); $4,284 for manufacturers’                 Regulatory Affairs, Office of
                                               well a product is likely to perform as an               and installers’ compliance with the                   Management and Budget, Attention:
                                               insulator and allows consumers to                       Rule’s recordkeeping requirements,                    Desk Officer for the Federal Trade
                                               determine whether the cost of the                       based on 285 hours (285 hours × $15.03                Commission, New Executive Office
                                               insulation is justified.                                per hour for clerical personnel); $50,501             Building, Docket Library, Room 10102,
                                                 On October 11, 2017, the Commission                   for manufacturers’ compliance with                    725 17th Street NW, Washington, DC
                                               sought comment on the information                       third-party disclosure requirements,                  20503. Comments sent to OMB by U.S.
                                               collection requirements in the R-value                  based on 3,360 hours (3,360 hours ×                   postal mail are subject to delays due to
                                               Rule. 82 FR 47207. No germane                           $15.03 per hour for clerical personnel);              heightened security precautions. Thus,
                                               comments were received. As required                     and $2,561,300 for disclosure                         comments can also be sent via email to
                                               by OMB regulations, 5 CFR part 1320,                    compliance by installers, new home                    wliberante@omb.eop.gov.
                                               the FTC is providing this second                        sellers, and retailers (128,065 hours ×                  Because your comment will be placed
                                               opportunity for public comment.                         $20 per hour for sales persons).]                     on the publicly accessible FTC website
                                               Comments should address only the                                                                              at https://www.ftc.gov, you are solely
                                               information collection requirements of                  Request for Comment
                                                                                                                                                             responsible for making sure that your
                                               the current Rule. They should not                          You can file a comment online or on                comment does not include any sensitive
                                               address proposed Rule amendments                        paper. For the FTC to consider your                   or confidential information. In
                                               recently announced by the Commission                    comment, we must receive it on or                     particular, your comment should not
                                               in a separate proceeding.1                              before January 26, 2018. Write ‘‘R-value              include any sensitive personal
                                                 Estimated Annual Hours Burden:                        Rule: FTC File No. R811001’’ on your                  information, such as your or anyone
                                               131,740 hours.                                          comment. Your comment—including                       else’s Social Security number; date of
                                                 Likely Respondents and Estimated                      your name and your state—will be                      birth; driver’s license number or other
                                               Burden:                                                 placed on the public record of this                   state identification number, or foreign
                                                 Installation manufacturers, installers,               proceeding, including, to the extent                  country equivalent; passport number;
                                               new home builders/sellers, dealers and                  practicable, on the public Commission                 financial account number; or credit or
                                               retailers.                                              website, at http://www.ftc.gov/os/                    debit card number. You are also solely
                                                 (a) Installation manufacturers.                       publiccomments.shtm. As a matter of                   responsible for making sure that your
                                                 • Testing by installation                             discretion, the Commission tries to                   comment does not include any sensitive
                                               manufacturers ¥ 15 new products/year                    remove individuals’ home contact                      health information, such as medical
                                               × 2 hours each = 30 hours; and                          information from comments before                      records or other individually
                                                 • Disclosures by installation                         placing them on the Commission                        identifiable health information. In
                                               manufacturers ¥ [(144 manufacturers ×                   website.                                              addition, your comment should not
                                               20 hours) + (6 largest manufacturers ×                     Postal mail addressed to the                       include any ‘‘trade secret or any
                                               80 hours each] = 3,360 hours.                           Commission is subject to delay due to                 commercial or financial information
                                                 • Recordkeeping by installation                       heightened security screening. As a                   which . . . is privileged or
                                               manufacturers ¥ 150 manufacturers × 1                   result, we encourage you to submit your               confidential’’ —as provided by Section
                                               hour each = 150 hours.                                  comments online, or to send them to the               6(f) of the FTC Act, 15 U.S.C. 46(f), and
                                                 (b) Installers.                                       Commission by courier or overnight                    FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
daltland on DSKBBV9HB2PROD with NOTICES




                                                 • Disclosures by retrofit installers                  service. To make sure that the                        including in particular competitively
                                               (manufacturer’s insulation fact sheet) ¥                Commission considers your online                      sensitive information such as costs,
                                                                                                       comment, you must file it at https://                 sales statistics, inventories, formulas,
                                                  1 See, ‘‘FTC Proposes Updates to R-Value Rule for
                                                                                                       ftcpublic.commentworks.com/ftc/                       patterns, devices, manufacturing
                                               Home Insulation Products,’’ Dec. 4, 2017, https://
                                               www.ftc.gov/news-events/press-releases/2017/12/
                                                                                                       rvaluerulepra2 by following the                       processes, or customer names.
                                               ftc-proposes-updates-r-value-rule-home-insulation-      instructions on the web-based form.                      Comments containing material for
                                               products.                                               When this Notice appears at http://                   which confidential treatment is


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                                               61304                    Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Notices

                                               requested must be filed in paper form,                  relinquish its status as a PSO for any                a PSO’s listing expires. Section 3.108(d)
                                               must be clearly labeled ‘‘Confidential,’’               reason, or when a PSO’s listing expires.              of the Patient Safety Rule requires
                                               and must comply with FTC Rule 4.9(c).                   AHRQ has accepted a notification of                   AHRQ to provide public notice when it
                                               In particular, the written request for                  voluntary relinquishment from the                     removes an organization from the list of
                                               confidential treatment that accompanies                 Regenstrief Center for Healthcare                     federally approved PSOs.
                                               the comment must include the factual                    Engineering at Purdue University                         AHRQ has accepted a notification
                                               and legal basis for the request, and must               Patient Safety Organization (RCHE                     from RCHE Purdue PSO, a component
                                               identify the specific portions of the                   Purdue PSO) of its status as a PSO, and               entity of Purdue University, PSO
                                               comment to be withheld from the public                  has delisted the PSO accordingly.                     number P0168, to voluntarily relinquish
                                               record. See FTC Rule 4.9(c). Your                       DATES: The directories for both listed                its status as a PSO. Accordingly, RCHE
                                               comment will be kept confidential only                  and delisted PSOs are ongoing and                     Purdue PSO was delisted effective at
                                               if the General Counsel grants your                      reviewed weekly by AHRQ. The                          12:00 Midnight ET (2400) on December
                                               request in accordance with the law and                  delisting was effective at 12:00 Midnight             15, 2017.
                                               the public interest. Once your comment                  ET (2400) on December 15, 2017.                          More information on PSOs can be
                                               has been posted on the public FTC                       ADDRESSES: Both directories can be                    obtained through AHRQ’s PSO website
                                               website—as legally required by FTC                      accessed electronically at the following              at http://www.pso.ahrq.gov.
                                               Rule 4.9(b)—we cannot redact or                         HHS website: http://www.pso.ahrq.gov/
                                               remove your comment from the FTC                                                                              Sharon B. Arnold,
                                                                                                       listed.                                               Deputy Director.
                                               website, unless you submit a
                                                                                                       FOR FURTHER INFORMATION CONTACT:
                                               confidentiality request that meets the                                                                        [FR Doc. 2017–27803 Filed 12–26–17; 8:45 am]
                                               requirements for such treatment under                   Eileen Hogan, Center for Quality                      BILLING CODE 4160–90–P
                                               FTC Rule 4.9(c), and the General                        Improvement and Patient Safety, AHRQ,
                                               Counsel grants that request.                            5600 Fishers Lane, Room 06N94B,
                                                  The FTC Act and other laws that the                  Rockville, MD 20857; Telephone (toll                  DEPARTMENT OF HEALTH AND
                                               Commission administers permit the                       free): (866) 403–3697; Telephone (local):             HUMAN SERVICES
                                               collection of public comments to                        (301) 427–1111; TTY (toll free): (866)
                                               consider and use in this proceeding as                  438–7231; TTY (local): (301) 427–1130;                Food and Drug Administration
                                               appropriate. The Commission will                        Email: pso@ahrq.hhs.gov.
                                               consider all timely and responsive                      SUPPLEMENTARY INFORMATION:                            [Docket No. FDA–2017–D–6784]
                                               public comments that it receives on or                  Background
                                               before January 26, 2018. For information                                                                      Implementation of Pathogen Reduction
                                               on the Commission’s privacy policy,                        The Patient Safety and Quality                     Technology in the Manufacture of
                                               including routine uses permitted by the                 Improvement Act of 2005, 42 U.S.C.                    Blood Components in Blood
                                               Privacy Act, see https://www.ftc.gov/                   299b–21 to b–26, (Patient Safety Act)                 Establishments: Questions and
                                               site-information/privacy-policy.                        and the related Patient Safety and                    Answers; Draft Guidance for Industry;
                                                                                                       Quality Improvement Final Rule, 42                    Availability
                                               David C. Shonka,                                        CFR part 3 (Patient Safety Rule),
                                               Acting General Counsel.                                 published in the Federal Register on                  AGENCY:    Food and Drug Administration,
                                               [FR Doc. 2017–27868 Filed 12–26–17; 8:45 am]            November 21, 2008, 73 FR 70732–                       HHS.
                                               BILLING CODE 6750–01–P                                  70814, establish a framework by which                 ACTION:   Notice of availability.
                                                                                                       hospitals, doctors, and other health care
                                                                                                       providers may voluntarily report                      SUMMARY:  The Food and Drug
                                               DEPARTMENT OF HEALTH AND                                information to Patient Safety                         Administration (FDA or Agency) is
                                               HUMAN SERVICES                                          Organizations (PSOs), on a privileged                 announcing the availability of a draft
                                                                                                       and confidential basis, for the                       document entitled ‘‘Implementation of
                                               Agency for Healthcare Research and                      aggregation and analysis of patient                   Pathogen Reduction Technology in the
                                               Quality                                                 safety events.                                        Manufacture of Blood Components in
                                                                                                          The Patient Safety Act authorizes the              Blood Establishments: Questions and
                                               Patient Safety Organizations:                           listing of PSOs, which are entities or                Answers; Draft Guidance for Industry.’’
                                               Voluntary Relinquishment From the                       component organizations whose                         The draft guidance document provides
                                               Regenstrief Center for Healthcare                       mission and primary activity are to                   blood establishments that collect or
                                               Engineering at Purdue University                        conduct activities to improve patient                 process blood and blood components
                                               Patient Safety Organization (RCHE                       safety and the quality of health care                 with recommendations for
                                               Purdue PSO)                                             delivery.                                             implementing pathogen reduction
                                                                                                          HHS issued the Patient Safety Rule to              technology in the manufacture of
                                               AGENCY: Agency for Healthcare Research
                                                                                                       implement the Patient Safety Act.                     pathogen-reduced blood components.
                                               and Quality (AHRQ), Department of
                                                                                                       AHRQ administers the provisions of the                The guidance also provides answers to
                                               Health and Human Services (HHS).
                                                                                                       Patient Safety Act and Patient Safety                 frequently asked questions concerning
                                               ACTION: Notice of delisting.
                                                                                                       Rule relating to the listing and operation            the implementation of the INTERCEPT®
                                               SUMMARY:    The Patient Safety Rule                     of PSOs. The Patient Safety Rule                      Blood System for Platelets and Plasma.
                                               authorizes AHRQ, on behalf of the                       authorizes AHRQ to list as a PSO an                   The recommendations apply to licensed
                                               Secretary of HHS, to list as a PSO an                   entity that attests that it meets the                 blood establishments that intend to
daltland on DSKBBV9HB2PROD with NOTICES




                                               entity that attests that it meets the                   statutory and regulatory requirements                 manufacture pathogen-reduced blood
                                               statutory and regulatory requirements                   for listing. A PSO can be ‘‘delisted’’ if             components using an FDA approved
                                               for listing. A PSO can be ‘‘delisted’’ by               it is found to no longer meet the                     pathogen reduction device.
                                               the Secretary if it is found to no longer               requirements of the Patient Safety Act                DATES: Submit either electronic or
                                               meet the requirements of the Patient                    and Patient Safety Rule, when a PSO                   written comments on the draft guidance
                                               Safety Act and Patient Safety Rule,                     chooses to voluntarily relinquish its                 by March 27, 2018 to ensure that the
                                               when a PSO chooses to voluntarily                       status as a PSO for any reason, or when               Agency considers your comment on this


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Document Created: 2017-12-27 02:23:39
Document Modified: 2017-12-27 02:23:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice and request for comment.
DatesComments must be received by January 26, 2018.
ContactRequests for additional information or
FR Citation82 FR 61302 

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