Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12489 

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 llll, 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–10555 Small Business Health 

Options Program (SHOP) Effective Date 

and Termination Notice Requirements 

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: Small Business 

Health Options Program (SHOP) 

Effective Date and Termination Notice 

Requirements; Use: We are requiring 

that for plan years beginning on or after 

January 1, 2017, the Small Business 

Health Options Program (SHOP) must 

ensure that a qualified health plan 

(QHP) issuer notifies qualified 

employees, enrollees, and new enrollees 

in a QHP through the SHOP of the 

effective date of coverage. As required 

by the Patient Protection and Affordable 

Care Act; HHS Notice of Benefit and 

Payment Parameter for 2016 (CMS– 

9944–F), which published February 27, 

2015, if any enrollee’s coverage through 

the SHOP is terminated due to nonpayment of premiums or a loss of the 

enrollee’s or employer group’s eligibility 

to participate in the SHOP, the SHOP 

must notify the enrollee or the qualified 

employer of the termination of such 

coverage. In the termination of coverage 

the SHOP must include the termination 

date and reason for termination to the 

enrollee or qualified employer. Form 

Number: CMS–10555 (OMB Control 

Number: 0938–New); Frequency: 

Annually; Affected Public: Private 

sector (Business or other for profits and 

Not-for-profit institutions); Number of 

Respondents: 445; Total Annual 

Responses: 1,335; Total Annual Hours: 

46,725. (For policy questions regarding 

this collection contact Christelle Jang at 

(410) 786–8438). 

Dated: March 4, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–05420 Filed 3–6–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Organ 

Transplantation (ACOT) 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice; correction. 

SUMMARY: The Health Resources and 

Services Administration published a 

notice in the Federal Register, FR 2015– 

03929 (February 26, 2015), announcing 

the meeting for the Advisory Committee 

on Organ Transplantation (ACOT). This 

action is to add dial-in information. 

Correction: In the Federal Register, 

FR 2015–03929 (February 26, 2015), 

please make the following addition: 

Participants can also join this meeting via 

conference call by calling the toll-free phone 

number 888–324–4391 and providing the 

participant pass code 7744447. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–05415 Filed 3–6–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Collaborative 

Interdisciplinary Team Science in NIDDK 

Research Areas (R24)–Hematopoiesis. 

Date: March 20, 2015. 

Time: 2:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Paul A. Rushing, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 747, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8895, 

rushingp@extra.niddk.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; RFA–DK14–011 

Chronic Kidney Disease Biomarkers 

Consortium (CKD BioCon) (U01). 

Date: March 24, 2015. 

Time: 11:30 a.m. to 3:30 p.m. 

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12490 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Ann A. Jerkins, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 759, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, 301–594–2242, 

jerkinsa@niddk.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; HIV-Associated 

Nephropathy Program Project. 

Date: March 30, 2015. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Michele L. Barnard, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 753, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, (301) 594–8898, 

barnardm@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK R24 Review. 

Date: March 30, 2015. 

Time: 2:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Robert Wellner, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 706, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, 301–594–4721, 

rw175w@nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Building a Kidney: 

Cells to Organ. 

Date: April 7, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Marriott at Metro 

Center, 775 12th St. NW., Washington, DC 

20005. 

Contact Person: Paul A. Rushing, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 747, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8895, 

rushingp@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK R24 Grant 

Review. 

Date: April 8, 2015. 

Time: 12:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Robert Wellner, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 706, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, 301–594–4721 

rw175w@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 3, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05306 Filed 3–6–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0165] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; Studies 

To Evaluate the Metabolism and 

Residue Kinetics of Veterinary Drugs 

in Food-Producing Animals: Validation 

of Analytical Methods Used in Residue 

Depletion Studies; Revised Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised guidance for 

industry (GFI #208) entitled ‘‘Studies to 

Evaluate the Metabolism and Residue 

Kinetics of Veterinary Drugs in FoodProducing Animals: Validation of 

Analytical Methods Used in Residue 

Depletion Studies’’ (VICH GL49(R)). 

This revised guidance, which provides 

minor updates to a final guidance on the 

same topic for which a notice of 

availability was published in the 

Federal Register of September 15, 2011, 

has been developed for veterinary use 

by the International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH). 

This revised VICH guidance document 

is intended to provide a general 

description of the criteria that have been 

found by the European Union, Japan, 

United States, Australia, New Zealand, 

and Canada to be suitable for the 

validation of analytical methods used in 

veterinary drug residue depletion 

studies. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

revised 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: Julia 

Oriani, Center for Veterinary Medicine 

(HFV–151), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0788, 

julia.oriani@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote the 

international harmonization of 

regulatory requirements. FDA has 

participated in efforts to enhance 

harmonization and has expressed its 

commitment to seek scientifically based 

harmonized technical procedures for the 

development of pharmaceutical 

products. One of the goals of 

harmonization is to identify, and then 

reduce, differences in technical 

requirements for drug development 

among regulatory agencies in different 

countries. 

FDA has actively participated in the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use for 

several years to develop harmonized 

technical requirements for the approval 

of human pharmaceutical and biological 

products among the European Union, 

Japan, and the United States. The VICH 

is a parallel initiative for veterinary 

medicinal products. The VICH is 

concerned with developing harmonized 

technical requirements for the approval 

of veterinary medicinal products in the 

European Union, Japan, and the United 

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