7608 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

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 lll, 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–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. 

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: 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 

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 forprofits and not-for-profit institutions, 

State, Local or Tribal Governments; 

Number of Respondents: 900; Total 

Annual Responses: 900; Total Annual 

Hours: 150. (For policy questions 

regarding this collection contact Jaya 

Ghildiyal at 301–492–5149.) 

Dated: February 6, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–02852 Filed 2–10–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Tribal Consultation Meeting 

AGENCY: Office of Head Start (OHS), 

Administration for Children and 

Families, HHS. 

ACTION: Notice of meeting. 

SUMMARY: Pursuant to the Improving 

Head Start for School Readiness Act of 

2007, Public Law 110–134, notice is 

hereby given of one 1-day Tribal 

Consultation Session to be held between 

the Department of Health and Human 

Services, Administration for Children 

and Families, Office of Head Start 

leadership and the leadership of Tribal 

Governments operating Head Start 

(including Early Head Start) programs. 

The purpose of this Consultation 

Session is to discuss ways to better meet 

the needs of American Indian and 

Alaska Native children and their 

families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations [42 U.S.C. 9835, 

Section 640(l)(4)]. 

DATES: March 16, 2015, from 1:00 p.m. 

to 5:00 p.m. 

Location: Southwest Consortium of 

Indian Head Start, Native American 

Child and Family Conference, Hotel 

Albuquerque at Old Town, 800 Rio 

Grande Boulevard Northwest, 

Albuquerque, New Mexico 87104. 

FOR FURTHER INFORMATION CONTACT: 

Robert Bialas, Regional Program 

Manager, Region XI, Office of Head 

Start, email Robert.Bialas@acf.hhs.gov 

or phone (202) 205–9497. Additional 

information and online meeting 

registration is available at http://

eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/

tc2015. 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) announces an Office of 

Head Start (OHS) Tribal Consultation 

for leaders of Tribal Governments 

operating Head Start and Early Head 

Start programs. 

The agenda for the scheduled OHS 

Tribal Consultation in Albuquerque, 

New Mexico, will be organized around 

the statutory purposes of Head Start 

Tribal Consultations related to meeting 

the needs of American Indian/Alaska 

Native children and families, taking into 

consideration funding allocations, 

distribution formulas, and other issues 

affecting the delivery of Head Start 

services in their geographic locations. In 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7609 

addition, OHS will share actions taken 

and in progress to address the issues 

and concerns raised in 2014 OHS Tribal 

Consultations. 

The Consultation Session will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 U.S.C. 

9835, Section 640(l)(4)(A)]. Designees 

must have a letter from the Tribal 

Government authorizing them to 

represent the tribe prior to the 

Consultation Session. Other 

representatives of tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of the Consultation 

Session will be prepared and made 

available within 45 days of the 

Consultation Session to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Robert Bialas at 

Robert.Bialas@acf.hhs.gov either prior 

to the Consultation Session or within 30 

days after the meeting. 

Oral testimony and comments from 

the Consultation Session will be 

summarized in each report without 

attribution, along with topics of concern 

and recommendations. OHS has sent 

hotel and logistical information for the 

New Mexico Consultation Session to 

tribal leaders via email and posted 

information on the Early Childhood 

Learning and Knowledge Center Web 

site at http://eclkc.ohs.acf.hhs.gov/hslc/ 

hs/calendar/tc2015. 

Dated: February 6, 2015. 

Linda K. Smith, 

Deputy Assistant Secretary, Early Childhood 

Development. 

[FR Doc. 2015–02859 Filed 2–10–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1031] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food and Drug 

Administration Recall Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 13, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0249. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

FDA Recall Regulation—21 CFR Part 7 

(OMB Control Number 0910–0249)— 

Extension 

Section 701 of the Federal Food, Drug, 

and Cosmetic Act charges the Secretary 

of Health and Human Services, through 

FDA, with the responsibility of assuring 

recalls (21 U.S.C. 371, Regulations and 

Hearings, and 21 CFR part 7, 

Enforcement Policy, Subpart C, Recalls 

(Including Product Corrections)— 

Guidance on Policy, Procedures, and 

Industry Responsibilities) which pertain 

to the recall regulations and provide 

guidance to manufacturers on recall 

responsibilities. The guidelines apply to 

all FDA-regulated products (i.e., food, 

including animal feed; drugs, including 

animal drugs; medical devices, 

including in vitro diagnostic products; 

cosmetics; biological products intended 

for human use; and tobacco). 

These responsibilities include 

providing FDA with complete details of 

the recall including reason(s) for the 

removal or correction, risk evaluation, 

quantity produced, distribution 

information, the firm’s recall strategy, a 

copy of any recall communication(s), 

and a contact official (§ 7.46 (21 CFR 

7.46)); notifying direct accounts of the 

recall, providing guidance regarding 

further distribution, giving instructions 

as to what to do with the product, 

providing recipients with a ready means 

of reporting to the recalling firm (§ 7.49); 

and submitting periodic status reports 

so that FDA may assess the progress of 

the recall. Status report information may 

be determined by, among other things, 

evaluation return reply cards, 

effectiveness checks and product 

returns (§ 7.53); and providing the 

opportunity for a firm to request in 

writing that FDA terminate the recall 

(§ 7.55(b)). 

A search of FDA’s database was 

performed to determine the number of 

recalls that took place during fiscal 

years 2011 to 2013. The resulting 

number of total recalls (11,403) from 

this database search were then averaged 

over the 3 years, and the resulting per 

year average of recalls (3,801) are used 

in estimating the current annual 

reporting burden for this report. The 

resulting number of total terminations 

(11,403) from this database search were 

then averaged over the 3 years, and the 

resulting per year average of 

terminations (3,801) are used in 

estimating the current annual reporting 

burden for this report. 

In the Federal Register of August 4, 

2014 (79 FR 45197), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the total annual 

industry burden to collect and provide 

the previous information to be 721,886 

burden hours. 

The following is a summary of the 

estimated annual burden hours for 

recalling firms (manufacturers, 

processors, and distributors) to comply 

with the voluntary reporting 

requirements of FDA’s recall 

regulations, recognizing that there may 

be a vast difference in the information 

collection and reporting time involved 

in different recalls of FDA’s regulated 

products. 

FDA estimates the burden of this 

collection of information as follows: 


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