Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices 71801 

these forms to (1) grant public health 

professionals the continuing education 

(CE) they need to maintain professional 

licenses and certifications, (2) create a 

transcript or summary of training at the 

participant’s request, (3) generate 

management reports, and (4) maintain 

training statistics; and a revision that 

will allow CDC to comply with new 

continuing education accreditation 

organization requirements for collection 

of additional profession-specific data. 

CDC is accredited by six different 

continuing education (CE) organizations 

to award CE: (1) The International 

Association for Continuing Education 

and Training (IACET) to provide 

Continuing Education Units (CEUs), (2) 

the Accreditation Council for 

Continuing Medical Education 

(ACCME) to provide Continuing 

Medical Education credits (CME), (3) 

the American Nurses Credentialing 

Center (ANNC) to provide Continuing 

Nurse Education credits (CNE), (4) the 

National Commission for Health 

Education Credentialing (NCHEC) to 

award CHES credit, (5) the 

Accreditation Council for Pharmacy 

Education (ACPE) to provide continuing 

pharmacy credit, and (6) the American 

Association of Veterinary State Boards 

to award Registry of Approved 

Continuing Education (RACE) credit. 

The accrediting organizations require a 

method of tracking participants who 

complete an educational activity and 

demographic data allows CDC to do so. 

Also, several of the organizations 

require a permanent record that 

includes the participant’s name, 

address, and phone number, to facilitate 

retrieval of historical information about 

when a participant completed a course 

or several courses during a time period. 

This information provides the basis for 

a transcript or for determining whether 

a person is enrolled in more than one 

course. CDC uses the email address to 

verify the participant’s electronic 

request for transcripts, verify course 

certificates, and send confirmation that 

a participant is registered for a course. 

Tracking course attendance and 

meeting accrediting organizations’ 

standards for reporting, require uniform 

standardized training application forms. 

The standardized data these forms 

request for laboratory training, 

classroom study, online training, and 

distance learning are not requested 

elsewhere. In other words, these forms 

do not duplicate requests for 

information from participants. Data are 

collected only once per course or once 

per new registration. The annual burden 

table has been updated to reflect an 

increase in distance learning to 6,792 

burden hours; that is an average burden 

of 5 minutes per respondent. There is no 

cost to respondents other than their 

time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name No. of 

respondents 

No. of 

responses per 

respondent 

Avg. burden 

per response 

(in hrs) 

Total burden 

(in hrs) 

Health Professionals ......................... Training and Continuing Education 

Online New Participant Registration Form (36.5).

75,000 1 5/60 6,250 

Laboratorians .................................... National Laboratory Training Network Registration Form (32.1).6,500 1 5/60 542 

Total ........................................... ........................................................... ........................ ........................ ........................ 6,792 

Dated: November 26, 2012. 

Ron A. Otten, 

Director, Office of Scientific Integrity (OSI), 

Office of the Associate Director for Science 

(OADS), Office of the Director, Centers for 

Disease Control and Prevention. 

[FR Doc. 2012–29174 Filed 12–3–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10418] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate 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. 

1. Type of Information Collection: 

Revision of a currently approved 

collection; Title of Information 

Collection: Annual MLR and Rebate 

Calculation Report and MLR Rebate 

Notices; Use: Under Section 2718 of the 

Affordable Care Act and implementing 

regulation at 45 CFR part 158, a health 

insurance issuer (issuer) offering group 

or individual health insurance coverage 

must submit a report to the Secretary 

concerning the amount the issuer 

spends each year on claims, quality 

improvement expenses, non-claims 

costs, federal and state taxes and 

licensing and regulatory fees, and the 

amount of earned premium. An issuer 

must provide an annual rebate if the 

amount it spends on certain costs 

compared to its premium revenue 

(excluding federal and states taxes and 

licensing and regulatory fees) does not 

meet a certain ratio, referred to as the 

medical loss ratio (MLR). An interim 

final rule (IFR) implementing the MLR 

was published on December 1, 2010 (75 

FR 74865) and modified by technical 

corrections on December 30, 2010 (75 

FR 82277), which added part 158 to 

Title 45 of the Code of Federal 

Regulations. The IFR was effective 

January 1, 2011. A final rule regarding 

selected provisions of the IFR was 

published on December 7, 2011 (76 FR 

76574, CMS–9998–FC) and an interim 

final rule regarding an issue not 

included in issuers’ reporting 

obligations (disbursement of rebates by 

non-federal governmental plans) was 

also published December 7, 2011 (76 FR 

76596, CMS–9998–IFC2) Both rules 

published on December 7, 2011 and 

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71802 Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices 

were effective January 1, 2012. Each 

issuer is required to submit annually 

MLR data, including information about 

any rebates it must provide, on a form 

prescribed by CMS, for each state in 

which the issuer conducts business. 

Each issuer is also required to provide 

a rebate notice to each policyholder that 

is owed a rebate and each subscriber of 

policyholders that are owed a rebate for 

any given MLR reporting year. 

Additionally, each issuer is required to 

maintain for a period of seven years all 

documents, records and other evidence 

that support the data included in each 

issuer’s annual report to the Secretary. 

Based upon HHS’ experience in the 

MLR data collection and evaluation 

process, HHS is updating its annual 

burden hour estimates to reflect the 

actual numbers of submissions, rebates 

and rebate notices. In addition, the 

notice requirement for issuers that do 

not owe rebates applied only to the 2011 

reporting year, and does not apply to 

2012 and subsequent MLR reporting 

years. 

We have simplified the format of the 

reporting form and the method by 

which issuers submit their data. For the 

2012 MLR reporting year, when 

submitting data to CMS, issuers will 

have the option to use either a Microsoft 

Excel (.xls) or a Comma Separated Value 

(.csv) file format. This will allow issuers 

flexibility and reduce the burden in 

submitting the MLR report. The new 

method will no longer include precalculated fields which will reduce the 

burden as well as the possibility of 

error. 

The 2012 MLR Reporting Form and 

instructions also reflect changes for the 

2012 reporting year and beyond that are 

set forth in the December 2011 Final 

Rule as to whether certain already 

reported expenditures such as ICD–10 

conversion costs are taken into account 

in calculating an issuer’s MLR. 

HHS has created and published a host 

of electronic training tools to assist 

issuers with the preparation and 

submission of MLR data forms and 

Rebate calculations. Consequently the 

agency is reducing its current burden 

hours from 354,570 to 311,302. Form 

Number: CMS–10418 (OCN: 0938– 

1164); Frequency: Annual submission 

for each respondent; Affected Public: 

Private Sector, Business or other forprofits and not-for-profit institutions; 

Number of Respondents: 502; Number 

of Responses: 3,085; Total Annual 

Hours: 311,302. (For policy questions 

regarding this collection, contact Carol 

Jimenez at (301) 492–4457. For all other 

issues, call (410) 786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by February 4, 2013: 

1. Electronically. You may submit 

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) 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 llll, Room C4–26– 

05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Dated: November 29, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–29243 Filed 12–3–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0081] 

Guidance on Investigational New Drug 

Applications for Positron Emission 

Tomography Drugs; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Investigational New Drug Applications 

for Positron Emission Tomography 

(PET) Drugs.’’ The guidance is intended 

to assist manufacturers of PET drugs in 

submitting investigational new drug 

applications (INDs). 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Kyong (Kaye) Kang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 2352, 

Silver Spring, MD 20993–0002, 301– 

796–2050. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Investigational 

New Drug Applications for Positron 

Emission Tomography (PET) Drugs.’’ 

The guidance summarizes the IND 

process for PET drugs, makes 

recommendations for how to submit an 

IND, provides advice on expanded 

access options for investigational PET 

drugs, and describes the process for 

requesting permission to charge for an 

investigational PET drug. 

A draft guidance of the same title was 

announced in the Federal Register on 

February 14, 2012 (77 FR 8262), and 

Docket No. FDA–2012–D–0081 was 

open for comments until May 14, 2012. 

We received comments from industry 

and professional societies. We have 

carefully considered, and where 

appropriate, we have made corrections, 

added information, or clarified the 

information in this guidance in response 

to the comments or on our own 

initiative. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on the submission of 

INDs for PET drugs. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

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