Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / Notices 10905 

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: Agency for Healthcare Research 

and Quality (AHRQ), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: 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: 

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 doris.lefkowitz@AHRQ.hhs.gov. 

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 

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 


srobinson on DSKHWCL6B1PROD with NOTICES
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: 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. 

SUMMARY: 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 

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). 

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, 


srobinson on DSKHWCL6B1PROD with NOTICES