42016 Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices 

Formats in year 3. AHRQ estimates the 

number of hospitals using Common 

Formats will remain level for the next 

three years at 1,000 hospitals. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Certification for Initial Listing Form * ................................................................ 17 1 18 306 

Certification for Continued Listing Form * ........................................................ 16 1 8 128 

Two Bona Fide Contracts Requirement Form ** ............................................. 30 1 1 30 

Disclosure Statement Form *** ........................................................................ 2 1 3 6 

Profile Form   ............................................................................................... 77 1 3 231 

Patient Safety Confidentiality Complaint Form ** * ........................................... 3 1 20/60 1 

Change of Listing Information *** ..................................................................... 24 1 05/60 2 

Common Formats ............................................................................................ 1,000 1 100 100,000 

Total *** ..................................................................................................... 1,169 NA NA 100,704 

* AHRQ expects the number of PSOs to remain relatively stable, with 65% of listed PSOs seeking continued listing. The number of new entities seeking listing as PSOs and PSOs seeking continued listing will be offset by the number of entities that will voluntarily relinquish their status 

as a PSO, allow their listing to expire, or have their listing revoked for cause by AHRQ. 

** The Two Bona Fide Contracts Requirement Form will be completed by each PSO within the 24-month period after listing by the Secretary. 

*** The Disclosure Statement Form and the Change of Listing Information form may be submitted by individual PSOs in different years. Due to 

changes in their operations, a PSO can submit more than one Change of Listing Information in a year. OCR is anticipating considerable variation 

in the number of complaints per year. Hence, the total for each year is expressed as an average of the expected total over the three year collection period. 

**** The Profile Form collects data from listed PSOs each calendar year. The prior version of this form, the PSO Information Form, began collecting data from listed PSOs each calendar year in 2011. 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate * Total cost 

Certification for Initial Listing Form .................................................. 17 306 $35.93 $10,994.58 

Certification for Continued Listing Form .......................................... 16 128 35.93 4,599.04 

Two Bona Fide Contracts Requirement Form ................................. 30 30 35.93 1,077.90 

Disclosure Statement Form ............................................................. 2 6 35.93 215.58 

Profile Form ..................................................................................... 77 231 35.93 8,299.83 

Patient Safety Confidentiality Complaint Form ................................ 3 1 35.93 35.93 

Change of Listing Information ......................................................... 24 2 35.93 71.86 

Common Formats ............................................................................ 1,000 100,000 35.93 3,593,000.00 

Total .......................................................................................... 1,169 100,704 NA 3,618,294.72 

* Based upon the mean of the hourly wages for healthcare practitioner and technical occupations, 29–0000, National Compensation Survey, 

May 2013, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ (http://www.bls.gov/oes/current/oes_nat.htm#29–0000). 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 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 health care 

research and health care 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: July 1, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–16670 Filed 7–17–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Management of Postpartum 

Hemorrhage 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for scientific 

information submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review of 

Management of Postpartum 

Hemorrhage, which is currently being 

conducted by the Evidence-based 

Practice Centers for the AHRQ Effective 

Health Care Program. Access to 


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Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices 42017 

published and unpublished pertinent 

scientific information will improve the 

quality of this review. AHRQ is 

conducting this systematic review 

pursuant to Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, and Section 

902(a) of the Public Health Service Act, 

42 U.S.C. 299a(a). 

DATES: Submission Deadline on or 

before August 18, 2014. 

ADDRESSES: 

Online submissions: http://effective

healthcare.AHRQ.gov/index.cfm/ 

submit-scientific-information-packets/. 

Please select the study for which you 

are submitting information from the list 

to upload your documents. 

Email submissions: SIPS@epc-src.org. 

Print Submissions 

Mailing Address 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, P.O. Box 69539, 

Portland, OR 97239. 

Shipping Address (FedEx, UPS, etc.) 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, 3710 SW U.S. Veterans 

Hospital Road, Mail Code: R&D 71, 

Portland, OR 97239. 

FOR FURTHER INFORMATION CONTACT: 

Ryan McKenna,Telephone: 503–220– 

8262 ext. 58653 or Email: SIPS@epcsrc.org. 

SUPPLEMENTARY INFORMATION: AHRQ has 

commissioned the Effective Health Care 

(EHC) Program Evidence-based Practice 

Centers to complete a review of the 

evidence for Management of Postpartum 

Hemorrhage. 

The EHC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Management of 

Postpartum Hemorrhage, including 

those that describe adverse events. The 

entire research protocol, including the 

key questions, is also available online 

at: http://effectivehealthcare.AHRQ.gov/ 

search-for-guides-reviews-and-reports/

?pageaction=displayproduct&

productID=1918. 

This notice is to notify the public that 

the EHC program would find the 

following information on Management 

of Postpartum Hemorrhage helpful: 

• A list of completed studies that 

your company has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

• For completed studies that do not 

have results on ClinicalTrials.gov, 

please provide a summary, including 

the following elements: study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/

enrolled/lost to follow-up/withdrawn/

analyzed, effectiveness/efficacy, and 

safety results. 

• A list of ongoing studies that your 

company has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 

• Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

company for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution will be very 

beneficial to the EHC Program. Since the 

contents of all submissions will be made 

available to the public upon request, 

materials submitted must be publicly 

available or can be made public. 

Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EHC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EHC program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/join-the-email-list1/. 

The systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. The entire 

research protocol, is also available 

online at: http://effectivehealthcare.

AHRQ.gov/search-for-guides-reviewsand-reports/?pageaction=display

product&productID=1918. 

The Key Questions (KQ) 

KQ1. What is the evidence for the 

comparative effectiveness of 

interventions for management of 

postpartum hemorrhage? 

a. What is the comparative 

effectiveness of interventions intended 

to treat postpartum hemorrhage likely 

due to atony? 

b. What is the comparative 

effectiveness of interventions intended 

to treat postpartum hemorrhage likely 

due to retained placenta? 

c. What is the comparative 

effectiveness of interventions intended 

to treat postpartum hemorrhage likely 

due to genital tract trauma? 

d. What is the comparative 

effectiveness of interventions intended 

to treat postpartum hemorrhage likely 

due to uncommon causes (e.g., 

coagulopathies, uterine inversion, 

subinvolution)? 

KQ2.What is the evidence for 

choosing one intervention over another 

and when to proceed to subsequent 

interventions for management of 

postpartum hemorrhage? 

KQ3. What are the comparative 

harms, including adverse events, 

associated with interventions for 

management of postpartum 

hemorrhage? 

KQ4. What is the comparative 

effectiveness of interventions to treat 

acute blood loss anemia after 

stabilization of postpartum hemorrhage? 

KQ5. What systems-level 

interventions are effective in improving 

management of postpartum 

hemorrhage? 

PICOTS (Population, Intervention, 

Comparator, Outcomes, Timing, and 

Setting) 

Population 

• KQ1–3: Women with postpartum 

hemorrhage (PPH) immediately postbirth to 12 weeks postpartum following 

pregnancy >24 weeks gestation. 

• KQ4: Women with stabilized PPH and 

acute blood loss anemia 

• KQ 1–5: All modes of birth 

Intervention(s) 

• KQ1–3, 5 

Æ Compression techniques (external 

uterine massage, bimanual 

compression, aortic compression) 

Æ Medications (oxytocin [Pitocin], 

prostaglandin El [Misoprostol, 

Cytotec], methylergonovine 

[Methergine], prostaglandin 15- 

methyl F2a [Hemabate], 

prostaglandin E2 [Dinoprostone], 

recombinant factor Vila 

[NovoSeven], and tranexamic acid 

[Cyklokapron]) 


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42018 Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices 

Æ Devices (Bakri postpartum balloon, 

Foley catheter, SengstakenBlakemore tube, Rusch balloon) 

Æ Procedures (manual removal of 

placenta, manual evacuation of clot, 

uterine tamponade, uterine artery 

embolization, laceration repair) 

Æ Surgeries (curettage, uterine artery 

ligation, uterine hemostatic 

compression suturing, 

hysterectomy) 

Æ Blood and fluid products 

Æ Anti-shock garment 

Æ Systems-level interventions (e.g., 

implementation of protocols, 

training) 

∑ KQ4 

Æ Interventions for acute blood loss 

anemia (e.g., iron replacement, 

erythropoietin) 

Comparator 

∑ Different intervention (any 

intervention compared with any 

other intervention) 

∑ Placebo 

Outcomes 

∑ Intermediate outcomes 

Æ Blood loss 

Æ Transfusion 

Æ ICU admission 

Æ Anemia 

Æ Length of stay 

∑ Final outcomes 

Æ Mortality 

Æ Uterine preservation 

Æ Future fertility 

Æ Breastfeeding 

Æ Psychological impact 

Æ Harms 

Timing 

∑ Immediately post-birth to 12 weeks 

postpartum 

∑ Primary (< 24 hours postpartum) or 

secondary (>= 24 hours postpartum) 

Setting 

All birth settings (hospital, birth 

center, home) 

Dated: July 1, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–16667 Filed 7–17–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10477, CMS– 

R–185 and CMS–10343] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. 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 or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

any of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments must be received by 

September 16, 2014. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). To be 

assured consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/Paperwork

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10477 Medicaid Incentives for 

Prevention of Chronic Disease (MIPCD) 

Demonstration 

CMS–R–185 Granting and Withdrawal of 

Deeming Authority to Private Nonprofit 

Accreditation Organizations and of State 

Exemption Under State Laboratory 

Programs and Supporting Regulations 

CMS–10343 State Plan Preprint for 

Medicaid Recovery Audit Contractors 

(RAC) Program 

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. 

The term ‘‘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 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request): Revision of a currently 

approved information collection; Title 

of Information Collection: Medicaid 

Incentives for Prevention of Chronic 


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