Attachment J -- 30 Day FR Notice

Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / Notices
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ healthcare research and
healthcare information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: February 15, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–4135 Filed 2–25–11; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

The Patient Safety and
Quality Improvement Act of 2005, 42
U.S.C. 299b-21 to b-26, (Patient Safety
Act), and its implementing regulation at
42 CFR part 3, provides for the
formation of Patient Safety
Organizations (PSO5), which collect,
aggregate, and analyze confidential
information regarding the quality and
safety of healthcare delivery. On
December 30, 2010, HHS issued
‘‘Guidance Regarding Patient Safety
Organizations’ Reporting Obligations
and the Patient Safety and Quality
Improvement Act of 2005’’ (Guidance)
which can be accessed electronically at:

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SUMMARY:

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http://www.PSO.AHRQ.gov/regulations/
guidance.pdf.
This notice announces the intention
of AHRQ to request that the Office of
Management and Budget (OMB) amend
the approved clearance, OMB No. 0935–
0143, that allows information collection
related to implementation of the Patient
Safety Act. This amendment includes a
new attestation form related to the
Guidance. In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection. The purpose of this notice is
to allow 30 days for public comment on
the new attestation form related to the
Guidance.
DATES: Comments on this notice must be
received by March 30, 2011.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
AHRQ, Reports Clearance Officer, by fax
at (301) 427–1000 (attention: AHRQ
Reports Clearance Officer) or by e-mail
at [email protected].
Copies of this proposed form and
specific details on the estimated burden
can be obtained from AHRQs Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427–1477.
SUPPLEMENTARY INFORMATION:
Proposed Form
This notice proposes the addition of
a new attestation form, ‘‘Supplemental
Attestations Regarding FDA Reporting
Obligations Of PSOs,’’ to the existing
approved clearance, ‘‘Patient Safety
Organization Certification for Initial
Listing and Related Forms and a Patient
Safety Confidentiality Complaint Form’’
(OMB No. 0935–0143).
In order to implement the Patient
Safety Act, HHS issued the Patient
Safety and Quality Improvement Final
Rule (Patient Safety Rule), published in
the Federal Register on November 21,
2008: 73 FR 70731–70814. Pursuant to
the Patient Safety Rule, entities seeking
to become and remain listed by the
Secretary as PSOs submit certifications
to the Secretary. These entities must
certify that they meet or will meet
specified statutory criteria and
requirements for PSOs, as further
explained in the Patient Safety Rule.
On December 30, 2010, HHS issued
Guidance to address questions that have
arisen regarding the obligations of PSOs
where they or the organization of which
they are a part are legally obligated
under the Federal Food, Drug, and
Cosmetic Act and its implementing
regulations to report certain information
to the FDA and to provide FDA with

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access to its records, including access
during an inspection of its facilities.
This proposed form will collect
information from PSOs as described in
the Guidance.
Methods of Collection
Existing PSOs will be required to
complete this proposed form
immediately; an entity seeking listing as
a PSO will be required to complete this
proposed form at the time it submits its
certifications for initial listing. Every
entity completing this proposed form
will be required to attest whether it is
subject to the Guidance. Entities that are
subject to the Guidance will be required
to make one to three additional
attestations. To complete this form, a
respondent will need to review each
attestation, check the appropriate ‘‘yes’
or ‘‘no’’ box that follows each applicable
attestation, and complete and sign the
form.
The burden estimate for completing
this form is 15 minutes per respondent;
fewer than 100 entities are expected to
submit responses.
Estimated Annual Costs to the Federal
Government
Under the Patient Safety Act and
Patient Safety Rule, AHRQ collects and
reviews certifications from entities that
seek listing or continued listing as
PSOs. Entities applying to be PSOs and
existing PSOs may also be required to
provide additional information to
AHRQ. The cost to AHRQ of processing
the information collected with the
above-described form is minimal: An
estimated equivalent of approximately
0.01 FTE or $1,500 and no new
overhead costs.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on the above
described attestation form are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research, quality improvement and
information dissemination functions,
including whether the information will
have practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and

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10906

Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / Notices

included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: February 15, 2011.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2011–4133 Filed 2–25–11; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[ATSDR–269]

Proposed Substances To Be Evaluated
for Set 25 Toxicological Profiles
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Request for comments on the
proposed substances to be evaluated for
Set 25 toxicological profiles.
AGENCY:

ATSDR is initiating the
development of its 25th set of
toxicological profiles (CERCLA Set 25).
This notice announces the list of
proposed substances that will be
evaluated for CERCLA Set 25
toxicological profile development.
ATSDR’s Division of Toxicology and
Environmental Medicine is soliciting
public nominations from the list of
proposed substances to be evaluated for
toxicological profile development.
ATSDR also will consider the
nomination of any additional, nonCERCLA substances that may have
public health implications, on the basis
of ATSDR’s authority to prepare
toxicological profiles for substances not
found at sites on the National Priorities
List. The agency will do so in order to
‘‘* * * establish and maintain inventory
of literature, research, and studies on
the health effects of toxic substances’’
under CERCLA Section 104(i)(1)(B), to
respond to requests for consultation
under section 104(i)(4), and to support
the site-specific response actions
conducted by ATSDR, as otherwise
necessary.
DATES: Nominations must be submitted
within 30 days of the publication of this
notice.
ADDRESSES: Nominations may be
submitted electronically. Refer to the
section Submission of Nominations
(below) for the specific address.
SUPPLEMENTARY INFORMATION: The
Superfund Amendments and

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Reauthorization Act of 1986 (SARA) [42
U.S.C. 9601 et seq.] amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA or Superfund) [42
U.S.C. 9601 et seq.] by establishing
certain requirements for ATSDR and the
U.S. Environmental Protection Agency
(EPA) with regard to hazardous
substances most commonly found at
facilities on the CERCLA National
Priorities List (NPL). Among these
statutory requirements is a mandate for
the Administrator of ATSDR to prepare
toxicological profiles for each substance
included on the Priority List of
Hazardous Substances. This list
identifies 275 hazardous substances that
ATSDR and EPA have determined pose
the most significant current potential
threat to human health. The availability
of the revised list of the 275 priority
substances was announced in the
Federal Register on March 6, 2008 (73
FR 12178). For prior versions of the list
of substances, see Federal Register
notices dated April 17, 1987 (52 FR
12866); October 20, 1988 (53 FR 41280);
October 26, 1989 (54 FR 43619); October
17, 1990 (55 FR 42067); October 17,
1991 (56 FR 52166); October 28, 1992
(57 FR 48801); February 28, 1994 (59 FR
9486); April 29, 1996 (61 FR 18744);
November 17, 1997 (62 FR 61332);
October 21, 1999 (64 FR 56792); October
25, 2001 (66 FR 54014); November 7,
2003 (68 FR 63098); and November 29,
2005 (70 FR 71506).
Proposed Substances To Be Evaluated
for Set 25 Toxicological Profiles
Each year, ATSDR develops a list of
substances to be considered for
toxicological profile development; this
list is compiled from ATSDR’s Priority
List of Hazardous Substances and from
previously nominated substances of
public health concern. The following 74
proposed substances will be considered
for Set 25 Toxicological Profile
development:
Candidate Substances for Profile
Development
1. s,s,s-Tributyl phosphorotrithioate
(CAS No. 000078–48–8).
2. 2,4-Dimethylphenol (CAS No.
000105–67–9).
3. Bromine (CAS No. 007726–95–6).
4. Bromodichloroethane (CAS No.
0000683–53–4).
5. Butyl benzyl phthalate (CAS No.
000085–68–7).
6. Dibenzofuran (CAS No. 000132–
64–9).
7. Dicofol (CAS No. 000115–32–2).
8. Methane (CAS No. 74–82–8).
9. Neptunium-237 (CAS No. 013994–
20–2).

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10. Palladium (CAS No. 007440–05–
3).
11. Parathion (CAS No. 000056–38–2).
12. Pentachlorobenzene (CAS No.
000608–93–5).
13. Polonium-210 (CAS No. 013981–
52–7).
14. Treflan (Trifluralin) (CAS No.
001582–09–8).
15. Trichlorofluoroethane (CAS No.
027154–33–2).
16. Fluorides (CAS Nos. 007782–41–
4, 007664–39–3, 016984–48–8).
17. Selenium (CAS No. 007782–49–2).
18. Aldrin/Dieldrin (CAS Nos.
000309–00–2, 000060–57–1).
19. Beryllium (CAS No. 007440–41–
7).
20. Creosote/Coal Tar (CAS Nos.
008021–39–4, 008007–45–2, 008001–
58–9, 065996–93–2).
21. DDT, DDE, DDD (CAS Nos.
000050–29–3, 000072–55–9, 000072–
54–8, 000789–02–6, 000053–19,
003424–82–6).
22. Di(2-ethylhexyl)phthalate (CAS
No. 000117–81–7).
23. Hexachlorobenzene (CAS No.
000118–74–1).
24. Methoxychlor (CAS No. 000072–
43–5).
25. 1,2–Dichloroethane (CAS No.
000107–06–2).
26. Asbestos (CAS Nos. 001332–21–4,
012001–29–5, 012172–73–5).
27. Benzidine (CAS No. 000092–87–
5).
28. Di-n-butyl phthalate (CAS No.
000084–74–2).
29. Pentachlorophenol (CAS No.
000087–86–5).
30. Endosulfan (CAS Nos. 000115–
29–7, 001031–07–8, 000959–98–8,
033213–65–9).
31. Ethion (CAS No. 000563–12–2).
32. Methylene chloride (CAS No.
000075–09–2).
33. Polychlorinated biphenyls (CAS
Nos. 001336–36–3, 011097–69–1,
011096–82–5, 012672–29–6, 053469–
21–9, 012767–79–2, 011104–28–2,
012674–11–2, 011141–16–5, 071328–
89–7, 026914–33–0).
34. Toluene (CAS No. 000108–88–3).
35. Chlorophenols (CAS Nos. 000088–
06–2, 025167–83–3, 000120–83–2,
000095–95–4, 000095–57–8, 004901–
51–3, 000935–95–5, 000058–90–2,
000106–48–9, 025167–80–0).
36. Hexachlorocyclopentadiene (CAS
No. 000077–47–4).
37. Mercury (CAS Nos. 007439–97–6,
022967–92–6, 007487–94–7).
38. 3,3′-Dichlorobenzidine (CAS No.
000091–94–1).
39. Chlorinated Dibenzodioxin (CDDs)
(CAS Nos. 001746–01–6, 034465–46–8,
037871–00–4, 041903–57–5, 036088–
22–9, 035822–46–9, 003268–87–9,

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