69854 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 

2014–0015, 1600 Clifton Rd. NE., 

Mailstop A–07, Atlanta, Georgia, 30333. 

Instructions: All submissions received 

must include the agency name and 

docket number. All relevant comments 

received will be posted without change 

to http://regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. All 

materials submitted will be available for 

public inspection Monday through 

Friday, except for legal holidays, from 9 

a.m. until 5 p.m., Eastern Standard 

Time, at 1600 Clifton Road NE., Atlanta, 

Georgia 30333. Please call ahead to 

(404) 639–4000 and ask for a 

representative from Immunization 

Safety Office to schedule your visit. You 

should be aware that this office is in a 

Federal government building; therefore, 

Federal security measures are 

applicable. For additional information, 

please see Roybal Campus Security 

Guidelines under SUPPLEMENTARY

INFORMATION. 

FOR FURTHER INFORMATION CONTACT: 

Tiffany Suragh; Centers for Disease 

Control and Prevention, National Center 

for Emerging and Zoonotic Infectious 

Diseases, Division of Healthcare Quality 

Promotion, Immunization Safety Office, 

l600 Clifton Road NE., Mailstop D–26; 

Atlanta, Georgia, 30329–4018; 

Telephone: (404) 639–4000. 

SUPPLEMENTARY INFORMATION: VAERS is 

an important and critical ‘‘early warning 

system’’ in the federal vaccine safety 

infrastructure for identifying adverse 

events after receipt of childhood, 

adolescent, and adult vaccines licensed 

for use in the United States (US). 

Healthcare providers and vaccine 

manufacturers are required under 

section 2125(b) of the Public Health 

Service Act (42 U.S.C. 300aa–25(b)) to 

file VAERS reports regarding the 

occurrence of any event set forth in the 

Vaccine Injury Table which occurs 

within 7 days of the administration of 

any vaccine set forth in the Table or 

within such longer period as is specified 

in the Table and the occurrence of any 

contraindicating reaction to a vaccine 

which is specified in the manufacturer’s 

package insert. VAERS also accepts 

reports on adverse events following 

receipt of other vaccines. Patients, 

parents and others aware of adverse 

events can also file VAERS reports. 

Although VAERS is not designed to 

assess if a vaccine caused an adverse 

event, VAERS provides CDC and FDA 

with important early information that 

might signal a potential problem. If the 

VAERS data suggest a possible 

association between an adverse event 

and vaccination, the relationship will be 

further assessed. In recent years VAERS 

has received approximately 30,000 US 

reports annually. 

VAERS is a mandated activity for the 

U.S. Department of Health and Human 

Services (HHS) and VAERS data are 

used by federal agencies, state health 

officials, health care providers, 

manufacturers, and the public, therefore 

it is important to maximize the 

usefulness of this system. The 

information collected by the proposed 

VAERS 2.0 form will be similar to that 

on the current VAERS–1 form so 

historical comparisons can be made; 

however, the changes in the draft 

VAERS 2.0 form should improve 

reporting efficiency and data quality. 

VAERS 2.0 offers standardized 

responses, clearer instructions and 

guidance, and improved online 

reporting. Select questions have been 

updated, with questions added, 

removed, and reorganized to decrease 

response burden and maximize 

usability. The draft VAERS 2.0 form can 

be found at http://www.regulations.gov. 

During the development of the draft 

VAERS 2.0 form, CDC and FDA sought 

input from key stakeholders in the 

federal government, state health officials 

involved in vaccine safety and vaccine 

programs, and other public health 

partners. In addition, the VAERS 2.0 

form was presented to three federal 

advisory committees, the Advisory 

Commission on Childhood Vaccines 

(September 5, 2014), the National 

Vaccine Advisory Committee 

(September 9, 2014), and the Advisory 

Committee on Immunization Practices 

(October, 2014) and was tested with 

potential reporters (e.g., physicians, 

nurses, pharmacists, patients, and 

parents). All public comments will be 

reviewed and considered prior to 

finalizing the VAERS 2.0 form. 

Roybal Campus Security Guidelines: 

The Edward R. Roybal Campus is the 

headquarters of the U.S. Centers for 

Disease Control and Prevention and is 

located at 1600 Clifton Road NE., 

Atlanta, Georgia. The Immunization 

Safety Office is in a Federal government 

building; therefore, Federal security 

measures are applicable. 

In planning your arrival time, please 

take into account the need to park and 

clear security. All visitors must enter 

the Roybal Campus through the 

entrance on Clifton Road; the guard 

force will direct visitors to the 

designated parking area. Upon arrival at 

the facility, visitors must present 

government issued photo identification 

(e.g., a valid federal identification 

badge, state driver’s license, state nondriver’s identification card, or passport). 

Non-United States citizens must 

complete the required security 

paperwork prior to the visit date and 

must present a valid passport, visa, 

Permanent Resident Card, or other type 

of work authorization document upon 

arrival at the facility. All persons 

entering the building must pass through 

a metal detector. Visitors will be issued 

a visitor’s ID badge at the entrance to 

Building 19 and will be escorted to a 

room to view the available materials. All 

items brought to HHS/CDC are subject 

to inspection. 

Dated: November 18, 2014. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2014–27678 Filed 11–21–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10407 and CMS– 

R–245] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HSS. 

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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 69855 

DATES: Comments must be received by 

January 23, 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 

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 lllll, 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–10407 Summary of Benefits and 

Coverage and Uniform Glossary 

CMS–R–245 Medicare and Medicaid 

Programs OASIS Collection 

Requirements as Part of the CoPs for 

HHAs and Supporting Regulations 

Under the Paperwork Reduction Act 

(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: Summary of 

Benefits and Coverage and Uniform 

Glossary; Use: Section 2715 of the 

Public Health Service Act directs the 

Department of Health and Human 

Services (HHS), the Department of Labor 

(DOL), and the Department of the 

Treasury (collectively, the 

Departments), in consultation with the 

National Association of Insurance 

Commissioners (NAIC) and a working 

group comprised of stakeholders, to 

‘‘develop standards for use by a group 

health plan and a health insurance 

issuer in compiling and providing to 

applicants, enrollees, and policyholders 

and certificate holders a summary of 

benefits and coverage explanation that 

accurately describes the benefits and 

coverage under the applicable plan or 

coverage.’’ To implement these 

disclosure requirements, collection of 

information requests relate to the 

provision of the following: Summary of 

benefits and coverage, which includes 

coverage examples; a uniform glossary 

of health coverage and medical terms; 

and a notice of modifications. Form 

Number: CMS–10407 (OMB control 

number 0938–1146); Frequency: 

Annual; Affected Public: Private 

Sector—Business or other for-profits 

and Not-for-profit institutions; Number 

of Respondents: 126,500; Number of 

Responses: 41,153,858; Total Annual 

Hours: 322,411. (For policy questions 

regarding this collection, contact 

Heather Raeburn at 301–492–4224.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare and 

Medicaid Programs OASIS Collection 

Requirements as Part of the CoPs for 

HHAs and Supporting Regulations; Use: 

The Outcome and Assessment 

Information Set (OASIS) data set is 

currently mandated for use by Home 

Health Agencies (HHAs) as a condition 

of participation (CoP) in the Medicare 

program. Since 1999, the Medicare CoPs 

have mandated that HHAs use the 

OASIS data set when evaluating adult 

non-maternity patients receiving skilled 

services. The OASIS is a core standard 

assessment data set that agencies 

integrate into their own patient-specific, 

comprehensive assessment to identify 

each patient’s need for home care that 

meets the patient’s medical, nursing, 

rehabilitative, social, and discharge 

planning needs. 

The Office of Management and Budget 

(OMB) approved the OASIS–C1 

information collection request on 

February 6, 2014. We originally planned 

to use OASIS–C1 to coincide with the 

original implementation of ICD–10 on 

October 1, 2014. However, on April 1, 

2014, the Protecting Access to Medicare 

Act of 2014 (PAMA) (Pub. L. 113–93) 

was enacted. This legislation prohibits 

CMS from adopting ICD–10 coding prior 

to October 1, 2015. Because OASIS–C1 

is based on ICD–10 coding, it is not 

possible to implement OASIS–C1 prior 

to October 1, 2015, when ICD–10 is 

implemented. The passage of the PAMA 

Act left us with the dilemma of how to 

collect OASIS data in the interim, until 

ICD–10 is implemented. 

The OASIS–C1/ICD–9 version is an 

interim version of the OASIS–C1 data 

item set that was created in response to 

the legislatively mandated ICD–10 

delay. There are five items in OASIS–C1 

that require ICD–10 codes. In the 

OASIS–C1/ICD–9 version, these items 

have been replaced with the 

corresponding items from OASIS–C that 

use ICD–9 coding. The OASIS–C1/ICD– 

9 version also incorporates updated 

clinical concepts, modified item 

wording and response categories and 

improved item clarity. In addition, the 

OASIS–C1/ICD–9 version includes a 

significant decrease in provider burden 

that was accomplished by the deletion 

of a number of non-essential data items 

from the OASIS–C data item set. Form 

Number: CMS–R–245 (OMB control 

number: 0938–0760); Frequency: 

Occasionally; Affected Public: Private 

sector—Business or other for-profit and 

Not-for-profit institutions; Number of 

Respondents: 12,014; Total Annual 

Responses: 17,268,890; Total Annual 

Hours: 15,305,484. (For policy questions 

regarding this collection contact Cheryl 

Wiseman at 410–786–1175). 

Dated: November 19, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–27756 Filed 11–21–14; 8:45 am] 

BILLING CODE 4120–01–P 


asabaliauskas on DSK5VPTVN1PROD with NOTICES