58354 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 

representation of both genders, ethnic 

and racial minorities, and persons with 

disabilities. Nominees must be U.S. 

citizens, and cannot be full-time 

employees of the U.S. Government. 

Candidates should submit the 

following items: 

• Current curriculum vitae, including 

complete contact information (name, 

affiliation, mailing address, telephone 

number, email address) 

• A letter of recommendation stating 

the qualifications of the candidate 

Nomination materials must be 

postmarked by October 24, 2014, and 

sent to: Kim Distel, Office of Infectious 

Diseases, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE., 

Mailstop D10, Atlanta, Georgia 30333, 

telephone (404) 639–2100. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both the 

Centers for Disease Control and 

Prevention, and the Agency for Toxic 

Substances and Disease Registry. 

Claudette Grant, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2014–23055 Filed 9–26–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10492] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

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 

November 28, 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 _________, 

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–10492 Data 

Submission for the Federally-faciliated 

Exchange User Fee Adjustment 

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: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Data 

Submission for the Federally-facilitated 

Exchange User Fee Adjustment; Use: 

The final rule ‘‘Coverage of Certain 

Preventive Services Under the 

Affordable Care Act’’ published by the 

Departments of Health and Human 

Services (HHS), the Treasury, and Labor 

on July 2, 2013 (78 FR 39870), sets forth 

regulations regarding coverage for 

certain preventive services under 

section 2713 of the Public Health 

Service Act, as added by the Patient 

Protection and Affordable Care Act, as 

amended, and incorporated into the 

Employee Retirement Income Security 

Act of 1974 and the Internal Revenue 

Code. Section 2713 of the Public Health 

Service Act requires coverage without 

cost sharing of certain preventive health 

services, including certain contraceptive 

services, in non-exempt, nongrandfathered group health plans and 

health insurance coverage. The final 

rules establish accommodations with 

respect to group health plans 

established or maintained by eligible 

organizations (and group health 

insurance coverage offered in 

connection with such plans). Eligible 

organizations are required to self-certify 

that they are eligible for this 

accommodation and provide a copy of 

such self-certification to their third 

party administrators. The final rules 

also set forth processes and standards to 

fund the payments for the contraceptive 

services that are provided for 

participants and beneficiaries in selfinsured plans of eligible organizations 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 58355 

under the accommodation described 

previously, through an adjustment in 

the Federally-facilitated Exchange (FFE) 

user fee payable by an issuer 

participating in an FFE. 

In order to facilitate the FFE user fee 

adjustment, and ensure that these user 

fee adjustments reflect payments for 

contraceptive services provided under 

this accommodation and that the 

adjustment is applied to the appropriate 

participating issuer in an FFE, the final 

rule requires an information collection 

from applicable participating issuers 

and third party administrators. In 

particular, the final regulations at 45 

CFR 156.50(d)(2)(i) provide that a 

participating issuer who seeks an FFE 

user fee adjustment must submit to HHS 

in the year following the benefit year in 

which payments for contraceptive 

services were made under the 

previously mentioned accommodation, 

identifying information for the 

participating issuer, each third party 

administrator, and each self-insured 

group health plan, as well as the total 

dollar amount of the payments for 

contraceptive services that were 

provided during the applicable calendar 

year under the accommodation. The 

final regulation at 45 CFR 

156.50(d)(2)(iii) also requires the third 

party administrator to submit to HHS 

identifying information for the third 

party administrator, the participating 

issuer, and each self-insured group 

health plan, as well as the total number 

of participants and beneficiaries in each 

self-insured group health plan during 

the applicable calendar year, the total 

dollar amount of payments made for 

contraceptive services, and an 

attestation that the payments for 

contraceptive services were made in 

compliance with 26 CFR 54.9815– 

2713A(b)(2) or 29 CFR 2590.715– 

2713A(b)(2). 

Furthermore, to determine the 

potential number of submissions 

provided by third party administrators 

and allow HHS to prepare to receive 

submissions in calendar year 2015, the 

final regulation at 45 CFR 

156.50(d)(2)(ii) requires third party 

administrators to submit to HHS a 

notification that the third party 

administrator intends for a participating 

issuer to seek an FFE user fee 

adjustment, by the later of January 1, 

2014, or the 60th calendar day following 

the date on which the third party 

administrator receives a copy of a selfcertification from an eligible 

organization. Additionally, a health 

insurance issuer providing payments for 

contraceptive services for participants 

and beneficiaries in insured plans (or 

student enrollees and covered 

dependents in student health insurance 

coverage) of eligible organizations to 

provide a written notice to such plan 

participants and beneficiaries (or such 

student enrollees and covered 

dependents) informing them of the 

availability of such payments. 

The burden associated with these 

processes includes the time for 

applicable participating issuers and 

third party administrators to submit 

identifying information and total 

payments made for contraceptive 

services in the prior calendar year, and 

for third party administrators to notify 

HHS of their intent to seek the user fee 

adjustment. HHS estimates 488 third 

party administrators, 48 QHP issuers, 

and 325 fully insured issuers of eligible 

organizations will submit this 

information. HHS anticipates that 

participating issuers in an FFE seeking 

a user fee adjustment and third party 

administrators with respect to which the 

FFE user fee adjustment is received will 

submit this information electronically. 

Form Number: CMS–10492 (OMB 

Control Number: 0938–NEW); 

Frequency: Once, Yearly. Affected 

Public: Private Sector—Business or 

other for-profits and Not-for-profit 

institutions; Number of Respondents: 

861; Total Annual Responses: 861 Total 

Annual Hours: 12,930. (For policy 

questions regarding this collection 

contact Jaya Ghildiyal at (301) 492– 

5149.) 

Dated: September 24, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–23132 Filed 9–26–14; 8:45 am] 

BILLING CODE 4120–01–U–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1409] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Records and 

Reports Concerning Experiences With 

Approved New Animal Drugs: Adverse 

Event Reports 

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 (the 

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 

adverse event reporting by FDA on new 

animal drugs and product/

manufacturing defects collected on 

paper forms. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 28, 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 


tkelley on DSK3SPTVN1PROD with NOTICES