Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7607 

Prevention, 1600 Clifton Road NE., 

Mailstop E–46, Atlanta, GA 30329, 

telephone: (404) 639–6007, email: lig7@

cdc.gov. 

Scientific questions should be 

addressed to Michele Owen, National 

Center for HIV/AIDS, Viral Hepatitis, 

STD, and TB Prevention, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE., Mailstop A–25, 

Atlanta, GA 30329; Phone 404–639– 

1046, email smo2@cdc.gov. 

SUPPLEMENTARY INFORMATION: HHS/CDC 

seeks to collaborate with one or more 

companies that have developed a 

simplified nucleic acid test that can 

detect acute or established HIV–1 

infection. Acute HIV infection is the 

early infection period associated with 

high viral load that occurs before the 

development of HIV antibodies, and 

established infection is that which 

occurs once antibodies are detectable. 

The objective of the collaboration is 

timely collection of data to evaluate the 

performance characteristics of 

simplified nucleic acid tests when used 

in their intended applications. The 

evaluation will be conducted in phases. 

The first round of evaluation will be 

done on well characterized stored or 

mock laboratory specimens. Following 

the initial round of evaluation, a subset 

of tests with high performance will be 

evaluated with prospectively collected 

specimens. Only tests that are near 

production (i.e., not first generation 

prototypes) will be eligible for the 

collaboration. Companies that are 

interested in collaborating must be 

planning to produce a simplified 

nucleic acid test for distribution in the 

United States and to seek FDA approval 

for diagnostic or prognostic use (priority 

given to tests with both applications). 

Confidential proposals, preferably six 

pages or less (excluding appendices), 

are solicited from companies which 

have a product that is suitable for 

commercial distribution. This 

collaboration will have an expected 

duration of 1 to 6 years. 

Currently, nucleic acid testing 

conducted as part of HHS/CDC’s 

laboratory algorithm is associated with 

a delay in returning results because 

testing is often conducted in referral 

laboratories. Likewise, pooled nucleic 

acid testing causes delays due to the 

time required to create and break down 

pools in the event of a positive pool. 

Rapid identification of acute and 

established HIV–1 infection using a 

simplified nucleic acid test may have a 

significant impact on patients with 

positive test results obtaining care and 

services more quickly. Therapeutic 

monitoring could also be conducted 

more efficiently using a simplified 

nucleic acid test. 

For this project, preference may be 

given to manufacturers that have 

produced rapid nucleic acid tests that 

can aid in HIV–1 diagnosis, and be used 

for monitoring responses to therapy. 

Tests should be simple to use on 

unprocessed specimens (e.g., whole 

blood) or include specimen processing 

in the design of the test. Preference will 

also be given for tests that can be 

performed in 60 minutes or less, that 

have the potential to be designated 

moderately complex or waived under 

the Clinical Laboratory Improvement 

Amendments (CLIA), and that are 

capable of both qualitative and 

quantitative applications. 

HHS/CDC and Collaborator 

Responsibilities 

HHS/CDC’s role may include, but will 

not be limited to, the following: 

(1) Providing scientific and technical 

expertise needed for the research 

project; 

(2) Providing appropriate panels of 

specimens, and conducting the tests; 

(3) Planning and conducting research 

studies of the diagnostic tests and 

interpreting results; and 

(4) Publishing research results. 

HHS/CDC anticipates that the role of 

the successful collaborator(s) will 

include the following: 

(1) Providing tests and finalized 

protocols that can be used in the 

evaluation; and 

(2) Providing the CDC Division of 

HIV/AIDS Prevention access to 

necessary data about the diagnostic tests 

in support of the research activities. 

Selection Criteria 

Proposals submitted for consideration 

should address, as fully as possible and 

to the extent relevant to the proposal, 

each of the following: 

(1) Data available on the performance 

of the test in persons with acute and 

established HIV–1 infection. 

(2) Information on the technology 

used for the test and its basic operating 

principals for detecting HIV RNA and/ 

or DNA. 

(3) Information on: 

a. the time required to perform the 

test; 

b. whether the test is performed on 

whole blood, serum, plasma, or dried 

blood spots; and 

c. the steps involved in performing 

the test on each specimen type; 

(4) Information on the storage 

requirements and stability of the test. 

(5) Plans and capability of the 

company to seek HHS/FDA approval 

and whether the company intends to 

seek a diagnostic claim, a prognostic 

claim (for patient monitoring) or both. 

(6) Plans the company has for seeking 

CLIA waiver status, if FDA approved. 

Dated: February 6, 2015. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2015–02793 Filed 2–10–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10433] 

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 

April 13, 2015. 

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 


tkelley on DSK3SPTVN1PROD with NOTICES
7608 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

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 lll, 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/

PaperworkReductionActof1995. 

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–10433 Initial Plan Data Collection 

To Support Qualified Health Plan 

(QHP) Certification and Other Financial 

Management and Exchange Operations 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Initial Plan Data 

Collection to Support Qualified Health 

Plan (QHP) Certification and Other 

Financial Management and Exchange 

Operations; Use: As required by the 

CMS–9989–F, Patient Protection and 

Affordable Care Act; Establishment of 

Exchanges and Qualified Health Plans; 

Exchange Standards for Employers (77 

FR 18310) (Exchange Establishment 

Rule), each Exchange must assume 

responsibilities related to the 

certification and offering of Qualified 

Health Plans (QHPs). In addition to data 

collection for the certification of QHPs, 

the reinsurance and risk adjustment 

programs outlined by the Affordable 

Care Act, detailed in 45 CFR part 153, 

as established by CMS–9975–F, Patient 

Protection and Affordable Care Act; 

Standards for Reinsurance, Risk 

Corridors, and Risk Adjustment (77 FR 

17220), have general information 

reporting requirements that apply to 

issuers, group health plans, third party 

administrators, and plan offerings 

outside of the Exchanges. Subsequent 

regulations for these programs including 

the final HHS Notice of Benefit and 

Payment Parameters for 2014 and the 

Program Integrity: Exchange, Premium 

Stabilization Programs, and Market 

Standards; Amendments to the HHS 

Notice of Benefit and Payment 

Parameters for 2014, and the final HHS 

Notice of Benefit and Payment 

Parameters for 2015 provide further 

reporting requirements. Form Number: 

CMS–10433 (OMB control number 

0938–1187); Frequency: Once; Affected 

Public: Individuals and households, 

private sector—business or other forprofits and not-for-profit institutions, 

State, Local or Tribal Governments; 

Number of Respondents: 900; Total 

Annual Responses: 900; Total Annual 

Hours: 150. (For policy questions 

regarding this collection contact Jaya 

Ghildiyal at 301–492–5149.) 

Dated: February 6, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–02852 Filed 2–10–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Tribal Consultation Meeting 

AGENCY: Office of Head Start (OHS), 

Administration for Children and 

Families, HHS. 

ACTION: Notice of meeting. 

SUMMARY: Pursuant to the Improving 

Head Start for School Readiness Act of 

2007, Public Law 110–134, notice is 

hereby given of one 1-day Tribal 

Consultation Session to be held between 

the Department of Health and Human 

Services, Administration for Children 

and Families, Office of Head Start 

leadership and the leadership of Tribal 

Governments operating Head Start 

(including Early Head Start) programs. 

The purpose of this Consultation 

Session is to discuss ways to better meet 

the needs of American Indian and 

Alaska Native children and their 

families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations [42 U.S.C. 9835, 

Section 640(l)(4)]. 

DATES: March 16, 2015, from 1:00 p.m. 

to 5:00 p.m. 

Location: Southwest Consortium of 

Indian Head Start, Native American 

Child and Family Conference, Hotel 

Albuquerque at Old Town, 800 Rio 

Grande Boulevard Northwest, 

Albuquerque, New Mexico 87104. 

FOR FURTHER INFORMATION CONTACT: 

Robert Bialas, Regional Program 

Manager, Region XI, Office of Head 

Start, email Robert.Bialas@acf.hhs.gov 

or phone (202) 205–9497. Additional 

information and online meeting 

registration is available at http://

eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/

tc2015. 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) announces an Office of 

Head Start (OHS) Tribal Consultation 

for leaders of Tribal Governments 

operating Head Start and Early Head 

Start programs. 

The agenda for the scheduled OHS 

Tribal Consultation in Albuquerque, 

New Mexico, will be organized around 

the statutory purposes of Head Start 

Tribal Consultations related to meeting 

the needs of American Indian/Alaska 

Native children and families, taking into 

consideration funding allocations, 

distribution formulas, and other issues 

affecting the delivery of Head Start 

services in their geographic locations. In 


tkelley on DSK3SPTVN1PROD with NOTICES