78970 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Notices 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR Email: 

OIRA_submission@omb.eop.gov. 

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: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new control number); Title of 

Information Collection: Outpatient and 

Ambulatory Surgery Experience of Care 

Survey; Use: We will use the 

information collected through the field 

test to inform the development of a 

larger national survey effort, including 

development of the final survey 

instrument and data collection 

procedures. Looking toward the survey 

development specifically, the data 

collected in this survey effort will be 

used to conduct a rigorous psychometric 

analysis of the survey content. The goal 

of such an analysis is to assess the 

measurement properties of the proposed 

instrument and sub-domain composites 

created from item subsets, to assure the 

information reported from any future 

administrations of the survey is welldefined. Such careful definition will 

prevent data distortion or 

misinformation if they are publicly 

reported. Data collection procedures 

will also be fine-tuned during this field 

test. The 30-day PRA package has been 

revised since the publication of the 60- 

day Federal Register notice on October 

4, 2013 (78 FR 61848). (Form Number: 

CMS–10500 (OCN: 0938-New); 

Frequency: Once; Affected Public: 

Individuals and households; Number of 

Respondents: 2,304; Total Annual 

Responses: 2,304; Total Annual Hours: 

384. (For policy questions regarding this 

collection contact Caren Ginsberg at 

410–786–0713.) 

2. Type of Information Collection 

Request: New collection (request for a 

new OMB control number); Title of 

Information Collection: Payment 

Collections Operations Contingency 

Plan; Use: Under sections 1401, 1411, 

and 1412 of the Affordable Care Act and 

45 CFR part 155 subpart D, an Exchange 

makes an advance determination of tax 

credit eligibility for individuals who 

enroll in QHP coverage through the 

Exchange and seek financial assistance. 

Using information available at the time 

of enrollment, the Exchange determines 

whether the individual meets the 

income and other requirements for 

advance payments and the amount of 

the advance payments that can be used 

to pay premiums. Advance payments 

are made periodically under section 

1412 of the Affordable Care Act to the 

issuer of the QHP in which the 

individual enrolls. Section 1402 of the 

Affordable Care Act provides for the 

reduction of cost sharing for certain 

individuals enrolled in a QHP through 

an Exchange, and section 1412 of the 

Affordable Care Act provides for the 

advance payment of these reductions to 

issuers. The statute directs issuers to 

reduce cost sharing for essential health 

benefits for individuals with household 

incomes between 100 and 400 percent 

of the Federal poverty level (FPL) who 

are enrolled in a silver level QHP 

through an individual market Exchange 

and are eligible for advance payments of 

the premium tax credit. The data 

collection will be used by HHS to make 

payments or collect charges from issuers 

under the following programs: advance 

payments of the premium tax credit, 

advanced cost-sharing reductions, and 

Marketplace user fees. The template will 

be used to make payments in January 

2014 and for a number of months 

thereafter, as may be required based on 

HHS’s operational progress. Form 

Number: CMS–10515 (OCN 0938– 

NEW). Frequency: Monthly. Affected 

Public: Private sector—Business or other 

for-profit and Not-for-profit institutions; 

Number of Respondents: 575. Total 

Annual Responses: 7,475. Total Annual 

Hours: 51,175. (For policy questions 

regarding this collection contact Jaya 

Ghildiyal at 301–492–5149.) 

Dated: December 23, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–31015 Filed 12–26–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10510] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB); Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice; correction. 

SUMMARY: This document corrects a date 

in the December 23, 2013, Federal 

Register notice (document identifier: 

CMS–10510) entitled ‘‘Basic Health 

Program Report for Health Insurance 

Exchange Premium.’’ 

FOR FURTHER INFORMATION CONTACT: 

Jessica Schubel at 410–786–3032. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 23, 2013 (78 FR 77469), 

we published an emergency Paperwork 

Reduction Act (PRA) notice for the 

information collection request entitled 

‘‘Basic Health Program Report for Health 

Insurance Exchange Premium.’’ 

While the date requested for OMB 

approval (January 6, 2014) is correct in 

the associated PRA package, the date in 

the December 23, 2013, Federal Register 

notice incorrectly reads ‘‘December 23, 

2013.’’ This notice corrects that error as 

follows. 

II. Correction 

In the Federal Register of December 

23, 2013, in FR Doc. 2013–30434, on 

page 77469, in the third column, in the 

third paragraph, correct the first 

sentence to read: 

We are requesting OMB review and 

approval of this collection by January 6, 

2014, with a 180-day approval period. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Notices 78971 

Dated: December 23, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–30989 Filed 12–26–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0179] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prior Notice of 

Imported Food Under the Public Health 

Security and Bioterrorism 

Preparedness and Response Act of 

2002 

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 January 27, 

2014. 

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 0910–0520. 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, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

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. Prior Notice of 

Imported Food Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002—21 CFR 

1.278 to 1.285 (OMB Control Number 

0910–0520)—Revision. 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) added section 801(m) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 381(m)), which 

requires that we receive prior notice for 

food, including food for animals, that is 

imported or offered for import into the 

United States. Sections 1.278 to 1.282 of 

our regulations (21 CFR 1.278 to 1.282) 

set forth the requirements for submitting 

prior notice; §§ 1.283(d) and 1.285(j) (21 

CFR 1.283(d) and 1.285(j)) set forth the 

procedure for requesting our review 

after we have refused admission of an 

article of food under section 801(m)(1) 

of the FD&C Act or placed an article of 

food under hold under section 801(l) of 

the FD&C Act; and § 1.285(i) (21 CFR 

1.285(i)) sets forth the procedure for 

post-hold submissions. 

Section 304 of the FDA Food Safety 

Modernization Act (FSMA) (Pub. L. 

111–353) amended section 801(m) of the 

FD&C Act to require a person submitting 

prior notice of imported food, including 

food for animals, to report, in addition 

to other information already required, 

‘‘any country to which the article has 

been refused entry.’’ In the Federal 

Register of May 5, 2011 (76 FR 25542), 

we issued an interim final rule (IFR) 

entitled ‘‘Information Required in Prior 

Notice of Imported Food’’ (2011 IFR) 

that implemented section 304 of FSMA 

and requested public comments. OMB 

approved the collection of information 

requirements of the 2011 IFR under 

OMB control number 0910–0683. On 

May 30, 2013 (78 FR 32359), we 

published a final rule that adopts, 

without change, the regulatory 

requirements established in the 2011 

IFR, specifically that a person 

submitting prior notice of imported 

food, including food for animals, must 

report the name of any country that has 

refused entry of that product. In this 

request for extension of OMB approval 

under the PRA, we are combining the 

burden hours associated with OMB 

control number 0910–0683 (collection 

entitled ‘‘Information Required in Prior 

Notice of Imported Food’’) with the 

burden hours approved under OMB 

control number 0910–0520 (collection 

entitled ‘‘Prior Notice of Imported Food 

Under the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002’’). 

Advance notice of imported food 

allows us, with the support of the U.S. 

Customs and Border Protection (CBP), to 

target import inspections more 

effectively and help protect the nation’s 

food supply against terrorist acts and 

other public health emergencies. By 

requiring that a prior notice contain 

additional information that indicates 

prior refusals by any country and also 

identifies the country or countries, we 

may better identify imported food 

shipments that may pose safety and 

security risks to U.S. consumers. This 

additional knowledge can further help 

us to make better informed decisions in 

managing the potential risks of imported 

food shipments into the United States. 

Any person with knowledge of the 

required information may submit prior 

notice for an article of food. Thus, the 

respondents to this information 

collection may include importers, 

owners, ultimate consignees, shippers, 

and carriers. 

Our regulations require that prior 

notice of imported food be submitted 

electronically using CBP’s Automated 

Broker Interface of the Automated 

Commercial System (ABI/ACS) 

(§ 1.280(a)(1)) or the FDA Prior Notice 

System Interface (PNSI) (Form FDA 

3540) (§ 1.280(a)(2)). PNSI is an 

electronic submission system available 

on the FDA Industry Systems page at 

http://www.access.fda.gov/. Information 

we collect in the prior notice 

submission includes: The submitter and 

transmitter (if different from the 

submitter); entry type and CBP 

identifier; the article of food, including 

complete FDA product code; the 

manufacturer, for an article of food no 

longer in its natural state; the grower, if 

known, for an article of food that is in 

its natural state; the FDA Country of 

Production; the name of any country 

that has refused entry of the article of 

food; the shipper, except for food 

imported by international mail; the 

country from which the article of food 

is shipped or, if the food is imported by 

international mail, the anticipated date 

of mailing and country from which the 

food is mailed; the anticipated arrival 

information or, if the food is imported 

by international mail, the U.S. recipient; 

the importer, owner, and ultimate 

consignee, except for food imported by 

international mail or transshipped 

through the United States; the carrier 

and mode of transportation, except for 

food imported by international mail; 

and planned shipment information, 

except for food imported by 

international mail (§ 1.281). 

Much of the information collected for 

prior notice is identical to the 

information collected for our importer’s 

entry notice, which has been approved 

under OMB control number 0910–0046. 

The information in an importer’s entry 

notice is collected electronically via 

CBP’s ABI/ACS at the same time the 

respondent files an entry for import 

with CBP. To avoid double-counting the 

burden hours already counted in the 

importer’s entry notice information 

collection, the burden hour analysis in 


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