44176 Federal Register / Vol. 79, No. 146 / Wednesday, July 30, 2014 / Notices 

Leroy Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–17898 Filed 7–29–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10433] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB) 

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. 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: The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

the accuracy of the estimated burden; 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

section 3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. 

This is necessary to ensure compliance 

with an initiative of the Administration. 

We are requesting an emergency review 

under 5 CFR Part 1320(a)(2)(i) because 

public harm is reasonably likely to 

result if the normal clearance 

procedures are followed. We are seeking 

emergency approval for modifications to 

the information collection request (ICR) 

currently approved under Office of 

Management and Budget (OMB) control 

number 0938–1187 to include account 

registration elements associated with 

submitting data through the Amazon 

Cloud EDGE Server or the On-Premise 

EDGE server. As a result of contractor 

changes and technical design changes to 

our distributed data collection (DDC) 

approach for implementing the risk 

adjustment and reinsurance programs, 

we must change the data elements that 

issuers will submit as part of the DDC 

information collection requirements. 

These modifications will permit us to 

register EDGE servers with the 

appropriate issuer accounts, permitting 

CMS to make risk adjustment and 

reinsurance payments to issuers. 

DATES: Comments must be received by 

August 27, 2014. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. 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: CMS–10433/OMB Control 

Number 0938–1187, 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–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. In 

compliance with the requirement of 

section 3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. 

This is necessary to ensure compliance 

with an initiative of the Administration. 

We are requesting an emergency review 

under 5 CFR Part 1320(a)(2)(i) because 

public harm is reasonably likely to 

result if the normal clearance 

procedures are followed. 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved information 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 

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Federal Register / Vol. 79, No. 146 / Wednesday, July 30, 2014 / Notices 44177 

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 for-profits and Not-for-profit 

institutions, State, Local or Tribal 

Governments; Number of Respondents: 

2400; Total Annual Responses: 9,600; 

Total Annual Hours: 600. (For policy 

questions regarding this collection 

contact Jaya Ghildiyal 301–492–5149). 

We are requesting OMB review and 

approval of this collection by August 27, 

2014, with a 180-day approval period. 

Written comments and 

recommendations will be considered 

from the public if received by the date 

and address noted below. 

Dated: July 25, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–17971 Filed 7–29–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0360] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

FDA Safety Communication 

Readership Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘FDA Safety Communication 

Readership Survey’’ has been approved 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA). 

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: On May 

21, 2014, the Agency submitted a 

proposed collection of information 

entitled ‘‘FDA Safety Communication 

Readership Survey’’ to OMB for review 

and clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0341. The 

approval expires on July 31, 2017. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: July 24, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–17891 Filed 7–29–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0501] 

Center for Devices and Radiological 

Health Appeals Processes: Questions 

and Answers About 517A; Guidance 

for Industry and Food and Drug 

Administration Staff 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Center for Devices and Radiological 

Health (CDRH) Appeals Processes: 

Questions and Answers About 517A.’’ 

This document provides CDRH’s 

interpretation of key provisions of 

section 517A of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), which 

were added by the FDA Safety and 

Innovation Act (FDASIA), as these 

provisions pertain to requests for 

documentation of rationales for 

significant decisions and requests for 

supervisory review of regulatory 

decisions and actions taken by CDRH. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single copy of the guidance document 

entitled ‘‘Center for Devices and 

Radiological Health Appeals Processes: 

Questions and Answers About 517A’’ to 

the Office of the Center Director, 

Guidance and Policy Development, 

CDRH, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Ruth Fischer, CDRH, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5400, Silver Spring, 

MD 20993–0002, 301–796–5735. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In July 2012, section 517A of the 

FD&C Act (21 U.S.C. 360g–l) was added 

by section 603 of FDASIA (Pub. L. 112– 

114). CDRH developed this guidance as 

a companion document to the final 

guidance entitled ‘‘Center for Devices 

and Radiological Health Appeals 

Processes,’’ which was issued on May 

17, 2013. The guidance ‘‘Center for 

Devices and Radiological Health 

Appeals Processes: Questions and 

Answers About 517A’’ provides CDRH’s 

interpretation of key provisions of 

section 517A of the FD&C Act as these 

provisions pertain to requests for 

documentation of rationales for 

significant decisions and requests for 

supervisory review of regulatory 

decisions and actions taken by CDRH. In 

particular, this document provides 

interpretations surrounding the 

statutory terms ‘‘significant decision’’ 

and ‘‘substantive summary.’’ It also 

addresses who may request 

documentation of significant decisions 

under section 517A of the FD&C Act, 

and how this provision relates to 

requests under the Freedom of 

Information Act. 

In the Federal Register of May 17, 

2013 (78 FR 29140), FDA announced the 

availability of the draft of this guidance. 

Interested persons were invited to 

comment by August 15, 2013. FDA 

considered the public comments 

received and revised the guidance, as 

appropriate. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

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