38034 Federal Register / Vol. 79, No. 128 / Thursday, July 3, 2014 / Notices 

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: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Durable Medical 

Equipment, Prosthetics, Orthotics and 

Supplies (DMEPOS) Competitive 

Bidding Program; Use: Section 302 of 

the MMA amended section 1847 of the 

Social Security Act (the Act) to require 

the implementation of the DMEPOS 

competitive bidding program. The Act 

provided the program requirements for 

the submission of bids in establishing 

payment rates and the awarding of 

contracts; provided the requirements for 

mergers and acquisitions; and a 

requirement for the Secretary to recompete contracts not less often than 

once every 3 years. The MMA also 

requires the Secretary to re-compete 

contracts not less often than once every 

3 years. The Round 1 Rebid contract 

period for all product categories except 

mail-order diabetic supplies expired on 

December 31, 2013. (Round 1 Rebid 

contracts for mail-order diabetic testing 

supplies ended on December 31, 2012.) 

The competition for the Round 1 Recompete began in August of 2012. The 

Round 1 Re-compete contracts and 

prices became effective on January 1, 

2014 and will expire on December 31, 

2016. Round 2 and National Mail-Order 

contracts and prices will expire on June 

30, 2016. 

The most recent approval for this 

information collection request (ICR) was 

issued by OMB on June 10, 2013. That 

ICR included the estimated burden to 

collect the information in bidding 

Forms A and B for the Round 1 Recompete. We are now seeking approval 

to collect the information in Forms A 

and B for competitions that will occur 

before 2017. For these upcoming 

competitions CMS will publish a 

slightly modified version of the RFB 

instructions and accompanying Forms A 

and B so that suppliers will be better 

able to identify and understand the 

requirements of the program. We 

decided to modify the Request for Bids 

(RFB) instructions and forms based on 

our experience from the last round of 

competition. The end result is expected 

to produce more complete and accurate 

information to evaluate suppliers. No 

new collection requirements have been 

added to the modified RFB instructions 

or Form A or B. Finally, we are retaining 

without change the Change of 

Ownership (CHOW) Purchaser Form 

and the CHOW Contract Supplier 

Notification Form, the Subcontracting 

Disclosure Form, and Forms C and D 

and their associated burden under this 

ICR. We intend to continue use of these 

forms on an ongoing basis. 

Form Number: CMS–10169 (OMB 

control number: 0938–1016); Frequency: 

Occasionally; Affected Public: Private 

Sector—Business or other for-profits 

and Individuals or Households; Number 

of Respondents: 49,625; Total Annual 

Responses: 39,380; Total Annual Hours: 

235,024. (For policy questions regarding 

this collection contact Michael Keane at 

410–786–4495.) 

Dated: June 27, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–15603 Filed 7–2–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Notice of Hearing: Reconsideration of 

Disapproval Texas Medicaid State Plan 

Amendment (SPA) 13–0045–MM2 and 

Texas Children’s Health Insurance 

Program SPA 13–0035 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of hearing: 

reconsideration of disapproval. 

SUMMARY: This notice announces an 

administrative hearing to be held on 

August 14, 2014, at the Department of 

Health and Human Services, Centers for 

Medicare and Medicaid Services, 

Division of Medicaid & Children’s 

Health, Dallas Regional Office, 1301 

Young Street, Room #801, 8th Floor 

Dallas, Texas 75202 to reconsider CMS’ 

decision to disapprove Texas’ Medicaid 

SPA 13–0045–MM2 and the CHIP SPA 

13–0035. 

Closing Date: Requests to participate 

in the hearing as a party must be 

received by the presiding officer by (15 

days after publication). 

FOR FURTHER INFORMATION CONTACT: 

Benjamin R. Cohen, Presiding Officer, 

CMS, 2520 Lord Baltimore Drive, Suite 

L, Baltimore, Maryland 21244, 

Telephone: (410) 786–3169. 

SUPPLEMENTARY INFORMATION: This 

notice announces an administrative 

hearing to reconsider CMS’ decision to 

disapprove the Texas Medicaid SPA 13– 

0045–MM2 and the Children’s Health 

Insurance Program (CHIP) SPA 13–0035 

which were submitted to the Centers for 

Medicare and Medicaid Services (CMS) 

on December 31, 2013 and disapproved 

on March 31, 2014. In part, these SPAs 

request CMS approval of the state’s 

proposed alternative single, streamlined 

application, both a paper version and 

online version, for completing an 

eligibility determination based on 

modified adjusted gross income (MAGI). 

Specifically, Texas’s proposals requiring 

all applicants to submit information on 

assets and provide detailed information 

on absent parents make the application 

longer and the information is not 

necessary for completing an eligibility 

determination based on MAGI. 

The issues to be considered at the 

hearing are: 

• Whether Texas Medicaid SPA 13– 

0045–MM2, complied with the statutory 

requirement in section 1902(a)(19) of 

the Social Security Act (the Act), under 

which the state plan must assure that 

eligibility for care and services under 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 128 / Thursday, July 3, 2014 / Notices 38035 

the plan will be determined and 

provided in a manner consistent with 

the simplicity of administration and the 

best interests of the recipients. 

Requiring applicants to provide 

additional detailed information, which 

is not necessary for determining their 

eligibility for coverage, is inconsistent 

with simplicity of administration of the 

state plan and is not in the best interests 

of Medicaid recipients or applicants. 

• Whether Texas CHIP SPA 13–0035, 

complied with section 2101(a) of the 

Act which specifies that the state plan 

must assure that eligibility for care and 

services must be provided in an 

effective and efficient manner. 

Requiring applicants to provide 

additional detailed information, which 

is not necessary for determining their 

eligibility for coverage, is inconsistent 

with simplicity of administration of the 

state plan and is not in the best interests 

of CHIP recipients or applicants. 

• Whether the state failed to comply 

with section 1902(e)(14)(C) of the Act, 

as added by section 2002 of the 

Affordable Care Act, and section 

2102(b)(1)(B)(v) of the Act, as added by 

section 2101 of the Affordable Care Act, 

which prohibit the use of asset or 

resource tests as criteria for Medicaid 

and CHIP eligibility among eligibility 

groups subject to MAGI, including 

children, pregnant women, parents, and, 

if eligible in a state, other nondisabled, 

nonelderly adults. Consistent with these 

statutory provisions, questions about 

assets and resources were not included 

in the Secretary’s model single 

streamlined application, which was 

released on April 30, 2013. 

• Whether the state complied with 

the requirements of sections 1902(a)(4) 

and 2101(a) of the Act, as implemented 

in 42 CFR 435.907 and 42 CFR 457.330, 

for approval of an alternative single, 

streamlined application. While an 

alternative application may be tailored 

to accommodate state preferences and 

policies, it must also reflect the general 

principles of the model application and 

must comply with the applicable 

provisions of law and regulation. The 

regulations at 42 CFR 435.907 and 42 

CFR 457.330 note specifically that the 

alternative application may be no more 

burdensome on the applicant than the 

model application. CMS guidance 

released June 18, 2013 further clarified 

that the application may only include 

questions that ‘‘are necessary for 

determining eligibility for coverage in a 

Qualified Health Plan (QHP) and all 

insurance affordability programs, or the 

administration of these programs.’’ 

Section 1116 of the Act and federal 

regulations at 42 CFR part 430, establish 

Department procedures that provide an 

administrative hearing for 

reconsideration of a disapproval of a 

state plan or plan amendment. CMS is 

required to publish a copy of the notice 

to a state Medicaid agency that informs 

the agency of the time and place of the 

hearing, and the issues to be considered. 

If we subsequently notify the agency of 

additional issues that will be considered 

at the hearing, we will also publish that 

notice. 

Any individual or group that wants to 

participate in the hearing as a party 

must petition the presiding officer 

within 15 days after publication of this 

notice, in accordance with the 

requirements contained at 42 CFR 

430.76(b)(2). Any interested person or 

organization that wants to participate as 

amicus curiae must petition the 

presiding officer before the hearing 

begins in accordance with the 

requirements contained at 42 CFR 

430.76(c). If the hearing is later 

rescheduled, the presiding officer will 

notify all participants. 

The notice to Texas announcing an 

administrative hearing to reconsider the 

disapproval of its SPAs reads as follows: 

Ms. Kay Ghahremani, State Medicaid 

Director, Texas Health and Human Services 

Commission, P.O. Box 13247, Austin, TX 

78711. 

Dear Ms. Ghahremani: 

I am responding to your request for 

reconsideration of the decision to disapprove 

Texas’s Medicaid state plan amendment 

(SPA) 13–0045–MM2 and the Children’s 

Health Insurance Program (CHIP) SPA 13– 

0035, which were submitted to the Centers 

for Medicare and Medicaid Services (CMS) 

on December 31, 2013 and disapproved on 

March 31, 2014. I am scheduling a hearing 

on your request for reconsideration to be held 

on August 14, 2014, at the Department of 

Health and Human Services, Centers for 

Medicare and Medicaid Services, Division of 

Medicaid & Children’s Health, Dallas 

Regional Office, 1301 Young Street, Room 

#801, Dallas, Texas 75202. 

In part, these SPAs request CMS approval 

of the state’s proposed alternative single, 

streamlined application, both a paper version 

and online version, for completing an 

eligibility determination based on modified 

adjusted gross income (MAGI). Specifically, 

Texas’s proposals requiring all applicants to 

submit information on assets and provide 

detailed information on absent parents make 

the application longer and the information is 

not necessary for completing an eligibility 

determination based on MAGI. 

In your request for reconsideration, you 

described changes that the state is 

considering with respect to these SPAs, and 

we will continue to talk with you about these 

changes. In the event that CMS and the state 

come to agreement on resolution of the 

issues, which formed the basis for 

disapproval, these SPAs may be moved to 

approval prior to the scheduled hearing. 

The issues to be considered at the hearing 

are: 

• Whether Texas Medicaid SPA 13–0045– 

MM2, complied with the statutory 

requirement in section 1902(a)(19) of the 

Social Security Act (the Act), under which 

the state plan must assure that eligibility for 

care and services under the plan will be 

determined and provided in a manner 

consistent with simplicity of administration 

and the best interests of the recipients. 

Requiring applicants to provide additional 

detailed information, which is not necessary 

for determining their eligibility for coverage, 

is inconsistent with the simplicity of 

administration of the state plan and is not in 

the best interests of Medicaid recipients or 

applicants. 

• Whether Texas CHIP SPA 13–0035, 

complied with section 2101(a) of the Act 

which specifies that the state plan must 

assure that eligibility for care and services 

must be provided in an effective and efficient 

manner. Requiring applicants to provide 

additional detailed information, which is not 

necessary for determining their eligibility for 

coverage, is inconsistent with simplicity of 

administration of the state plan and is not in 

the best interests of CHIP recipients or 

applicants. 

• Whether the state failed to comply with 

section 1902(e)(14)(C) of the Act, as added by 

section 2002 of the Affordable Care Act, and 

section 2102(b)(1)(B)(v) of the Act, as added 

by section 2101 of the Affordable Care Act 

which prohibit the use of asset or resource 

tests as criteria for Medicaid and CHIP 

eligibility among eligibility groups subject to 

MAGI, including children, pregnant women, 

parents, and, if eligible in a state, other 

nondisabled, nonelderly adults. Consistent 

with these statutory provisions, questions 

about assets and resources were not included 

in the Secretary’s model single streamlined 

application, which was released on April 30, 

2013. 

• Whether the state complied with the 

requirements of sections 1902(a)(4) and 

2101(a) of the Act, as implemented in 42 CFR 

435.907 and 42 CFR 457.330, for approval of 

an alternative single, streamlined 

application. While an alternative application 

may be tailored to accommodate state 

preferences and policies, it must also reflect 

the general principles of the model 

application and must comply with the 

applicable provisions of law and regulation. 

The regulations at 42 CFR 435.907 and 42 

CFR 457.330 note specifically that the 

alternative application may be no more 

burdensome on the applicant than the model 

application. CMS guidance released June 18, 

2013 further clarified that the application 

may only include questions ‘‘that are 

necessary for determining eligibility for 

coverage in a Qualified Health Plan (QHP) 

and all insurance affordability programs, or 

for the administration of these programs.’’ 

If the hearing date is not acceptable, I 

would be glad to set another date that is 

mutually agreeable to the parties. The 

hearing will be governed by the procedures 

prescribed by federal regulations at 42 CFR 

part 430. 

I am designating Mr. Benjamin R. Cohen as 

the presiding officer. If these arrangements 

present any problems, please contact the Mr. 

Cohen at (410) 786–3169. In order to 


tkelley on DSK3SPTVN1PROD with NOTICES
38036 Federal Register / Vol. 79, No. 128 / Thursday, July 3, 2014 / Notices 

facilitate any communication that may be 

necessary between the parties prior to the 

hearing, please notify the presiding officer to 

indicate acceptability of the hearing date that 

has been scheduled and provide names of the 

individuals who will represent the state at 

the hearing. 

Sincerely, 

Marilyn Tavenner, 

Administrator. 

Section 1116 of the Social Security Act 

(42 U.S.C. section 1316; 42 CFR section 

430.18) 

(Catalog of Federal Domestic Assistance 

program No. 13.714, Medicaid Assistance 

Program.) 

Dated: June 27, 2014. 

Marilyn Tavenner, 

Administrator, Center for Medicare & 

Medicaid Services. 

[FR Doc. 2014–15615 Filed 7–2–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0801] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Exports: 

Notification and Recordkeeping 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

export notification and recordkeeping 

requirements for persons exporting 

human drugs, biological products, 

devices, animal drugs, food, cosmetics, 

and tobacco that may not be marketed 

or sold in the United States. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 2, 2014. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 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. 

‘‘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 (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Exports: Notification and 

Recordkeeping Requirements—21 CFR 

1.101 (OMB Control Number 0910– 

0482)—Extension 

Section 801 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 381) charges the Secretary of 

Health and Human Services, through 

FDA, with the responsibility of assuring 

exports (Exports: Notification and 

Recordkeeping Requirements—§ 1.101 

(21 CFR 1.101)) which pertain to the 

exportation of unapproved new drugs, 

biologics, devices, animal drugs, food, 

cosmetics, and tobacco products are not 

be sold in the United States. 

The respondents to this information 

collection are exporters who have 

notified FDA of their intent to export 

unapproved products that may not be 

sold or markets in the United States as 

allowed under section 801(e) of the 

FD&C Act. In general, the notification 

identifies the product being exported 

(e.g. name, description, and in some 

cases, country of destination) and 

specifies where the notifications were 

sent. These notifications are sent only 

for an initial export. Subsequent exports 

of the same product to the same 

destination or in the case of certain 

countries identified in section 802(b) of 

the FD&C Act (21 U.S.C. 382) would not 

result in a notification to FDA. 

The recordkeepers to this information 

collection are exporters who export 

human drugs, biologics, devices, animal 

drugs, foods, cosmetics, and tobacco 

products that may not be sold in the 

United States and maintain records 

demonstrating their compliance with 

the requirements in section 801(e)(1) of 

the FD&C Act. 

On March 30, 2012, OMB approved 

‘‘Further Amendments to General 

Regulations of the Food and Drug 

Administration to Incorporate Tobacco 

Products,’’ OMB control number 0910– 

0690, which amended, among other 

sections, § 1.101 to incorporate tobacco 

products. This amendment reflects the 

Agency’s authority over tobacco 

products under the Family Smoking 

Prevention and Tobacco Control Act 

(Pub. L. 111–31) and added tobacco 

products to the list of products covered 

under § 1.101(a) and (b). 

FDA estimates the burden of this 

collection of information as follows: 


tkelley on DSK3SPTVN1PROD with NOTICES