Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices 13305 

Leroy Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–05077 Filed 3–7–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10225, CMS– 

10502, CMS–10503, CMS–10504 and 

CMS–10506] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

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 

(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 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the 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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by April 9, 2014. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

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 the 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© 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: Revision of a currently 

approved collection; Title of 

Information Collection: Disclosures 

Required of Certain Hospitals and 

Critical Access Hospitals Regarding 

Physician Ownership; Use: There is no 

Medicare prohibition against physician 

investment in a hospital or critical 

access hospitals (CAH). Likewise, there 

is no Medicare requirement that a 

hospital or CAH have a physician onsite at all times; although, there is a 

requirement that they be able to provide 

basic elements of emergency care to 

their patients. Medicare quality and 

safety standards are designed to provide 

a national framework that is sufficiently 

flexible to apply simultaneously to 

hospitals of varying sizes, offering 

varying ranges of services in differing 

settings across the nation. At the same 

time, however, patients might consider 

an ownership interest by their referring 

physician, the presence of a physician 

on-site or both to be important factors in 

their decisions about where to seek 

hospital care. A well-educated 

consumer is essential to improving the 

quality and efficiency of the healthcare 

system. Accordingly, patients should be 

made aware of the physician ownership 

of a hospital, whether or not a physician 

is present in the hospital at all times, 

and the hospital’s plans to address 

patients’ emergency medical conditions 

when a physician is not present. The 

intent of the disclosures is to increase 

the transparency of the hospital’s 

ownership and operations to patients as 

they make decisions about receiving 

care at the hospital. Please note that the 

associated information collection 

request has been revised subsequent to 

the publication of the 60-day Federal 

Register notice (78 FR 75925, December 

13, 2013.). Form Number: CMS–10225 

(OCN: 0938–1034); Frequency: 

Occasionally; Affected Public: Private 

sector—Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 2,597; Total Annual 

Responses: 30,654,968; Total Annual 

Hours: 261,447. (For policy questions 

regarding this collection contact Teresa 

Walden at 410–786–3755). 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Long Term Care 

Hospital Quality Reporting Program: 

Program Evaluation; Use: Section 

3004(a) of the Affordable Care Act 

(ACA) mandated that we establish a 

quality reporting program for Long Term 

Care Hospitals (LTCHs). Specifically, 

section 3004(a) added section 

1886(m)(5) to the Social Security Act 

(the Act) to establish a quality reporting 

program for LTCHs. This program 

requires that quality data be submitted 

by LTCH providers in a time, form and 

manner specified by the Secretary. 

We are interested in exploring how 

LTCH providers are responding to the 

new quality reporting program (QRP) 

and its measures. We believe that it is 

important to understand early trends in 

outcomes, to make adjustments as 

needed to enhance the effectiveness of 

the program, and to seek opportunities 

to minimize provider burden, and 

ensure the QRP is useful and 

meaningful to providers. The 

methodology employed in the 

evaluation is the utilization of 

qualitative interviews (as opposed to 

quantitative statistical methods). In 

consultation with research experts, we 

have decided that at this juncture it 

would be meaningful to use a rich, 

contextual approach to evaluation the 

process and success of the QRP 

initiative. 


emcdonald on DSK67QTVN1PROD with NOTICES
13306 Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices 

The decision to pursue this 

quantitative methodology in 2013, in 

which we learned that providers are 

anxious to have their voice heard, but 

that they did not feel comfortable 

expressing themselves fully in public 

open door forums. Providers desired 

some level of confidentiality, which this 

methodology affords. The intended use 

of the information collected is to help 

inform us about CMS providers’ 

experiences related to the QRPs, such as 

program impact related to quality 

improvement, burden, process-related 

issues, and education. This will also 

inform future measurement 

development for the LTCH QRP, future 

steps related to data validation, as well 

as future monitoring and evaluation. 

General findings may be used to discuss 

our future efforts in the QRP. Form 

Number: CMS–10502 (OCN: 0938– 

NEW); Frequency: Occasionally; 

Affected Public: Private sector— 

Business or other for-profits and Notfor-profit organizations; Number of 

Respondents: 30; Total Annual 

Responses: 30; Total Annual Hours: 71. 

(For policy questions regarding this 

collection contact Caroline Gallaher at 

410–786–8705.) 

3. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Inpatient 

Rehabilitation Facilities Quality 

Reporting Program: Program Evaluation; 

Use: Section 3004 of the Affordable Care 

Act (ACA) mandated that we establish 

a quality reporting program for Inpatient 

Rehabilitation Facilities (IRFs). 

Specifically, section 3004(a) added 

section 1886(j)(7) to the Social Security 

Act (‘‘the Act’’) to establish a quality 

reporting program (QRP) for IRFs. This 

program requires IRFs to submit quality 

data in a time, form and manner 

specified by the Secretary. 

We are interested in exploring how 

IRF providers are responding to the new 

QRP and its measures. We believe that 

it is important to understand early 

trends in outcomes, to make 

adjustments as needed to enhance the 

effectiveness of the program, and to seek 

opportunities to minimize provider 

burden, and ensure the quality reporting 

program is useful and meaningful to the 

providers. The methodology employed 

in the evaluation is the utilization of 

qualitative interviews (as opposed to 

quantitative statistical methods). In 

consultation with research experts, we 

have decided that at this juncture it 

would be meaningful to use a rich, 

contextual approach to evaluation the 

process and success of the QRP 

initiative. The decision to pursue this 

quantitative methodology in 2013, in 

which we learned that providers are 

anxious to have their voice heard, but 

that they did not feel comfortable 

expressing themselves fully in public 

open door forums. Providers desired 

some level of confidentiality, which this 

methodology affords. 

The intended use of the information 

collected is to help inform CMS 

providers’ experiences related to the 

QRPs, such as program impact related to 

quality improvement, burden, processrelated issues, and education. This will 

also inform future measurement 

development for the IRF QRP, future 

steps related to data validation, as well 

as future monitoring and evaluation. 

General findings may be used to discuss 

our future efforts in the QRP. Form 

Number: CMS–10503 (OCN: 0938– 

NEW); Frequency: Occasionally; 

Affected Public: Private sector— 

Business or other for-profits and Notfor-profit organizations; Number of 

Respondents: 30; Total Annual 

Responses: 30; Total Annual Hours: 71. 

(For policy questions regarding this 

collection contact Caroline Gallaher at 

410–786–8705.) 

4. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Hospice Quality 

Reporting Program: Program Evaluation; 

Use: Section 3004(c) of the Affordable 

Care Act (ACA) mandated that we 

establish a quality reporting program 

(QRP) for hospices. Specifically, section 

3004(c) added section 1814(i)(5) to the 

Social Security Act (the Act) to establish 

a quality reporting program for 

hospices. This program requires that 

quality data be submitted by hospices 

providers in a time, form and manner 

specified by the Secretary. 

We are interested in exploring how 

hospice providers are responding to the 

new QRP and its measures. We believe 

that it is important to understand early 

trends in outcomes, to make 

adjustments as needed to enhance the 

effectiveness of the program, and to seek 

opportunities to minimize provider 

burden, and ensure the quality reporting 

program is useful and meaningful to the 

providers. The methodology employed 

in the evaluation is the utilization of 

qualitative interviews (as opposed to 

quantitative statistical methods). In 

consultation with research experts, we 

have decided that at this juncture it 

would be meaningful to use a rich, 

contextual approach to evaluation the 

process and success of the QRP 

initiative. The decision to pursue this 

quantitative methodology in 2013, in 

which we learned that providers are 

anxious to have their voice heard, but 

that they did not feel comfortable 

expressing themselves fully in public 

open door forums. Providers desired 

some level of confidentiality, which this 

methodology affords. 

The intended use of the information 

collected is to help inform CMS 

providers’ experiences related to the 

QRPs, such as program impact related to 

quality improvement, burden, processrelated issues, and education. This will 

also inform future measurement 

development for the hospice QRP, 

future steps related to data validation, as 

well as future monitoring and 

evaluation. General findings may be 

used to discuss our future efforts in the 

QRP. Form Number: CMS–10504 (OCN: 

0938–NEW); Frequency: Occasionally; 

Affected Public: Private sector— 

Business or other for-profits and Notfor-profit organizations; Number of 

Respondents: 30; Total Annual 

Responses: 30; Total Annual Hours: 71. 

(For policy questions regarding this 

collection contact Caroline Gallaher at 

410–786–8705.) 

5. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Conditions of 

Participation for Community Mental 

Health Centers and Supporting 

Regulations in 42 CFR 485; Use: On 

June 17, 2011, we proposed for the first 

time new conditions of participation 

(CoPs) for community mental health 

centers (CMHCs). We finalized nd were 

finalized in the final rule that published 

October 29, 2013 (78 FR 64604), with an 

effective date 12-months after 

publication of the final rule. These CoPs 

which are based on criteria prescribed 

in law and are standards designed to 

ensure that each facility has properly 

trained staff to provide the appropriate 

safe physical environment for patients. 

These particular standards reflect 

comparable standards developed by 

industry organizations such as the Joint 

Commission. The primary users of this 

information will be State agency 

surveyors, CMS and CMHCs for the 

purpose of ensuring compliance with 

Medicare CoPs as well as ensuring the 

quality of care provided by CMHCs to 

patients. Form Number: CMS–10506 

(OCN: 0938–NEW); Frequency: 

Occasionally; Affected Public: Private 

sector—Business or other for-profits and 

Not-for-profit organizations; Number of 

Respondents: 130; Total Annual 

Responses: 79,530; Total Annual Hours: 

2,060,342. (For policy questions 

regarding this collection contact Mary 

Rossi-Coajou at 410–786–6051.) 


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Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices 13307 

Dated: March 5, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–05104 Filed 3–7–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–P–0768] 

Determination That ZEFAZONE 

(Cefmetazole Sodium) Injection, 

Equivalent to 1 Gram Base/Vial and 

Equivalent to 2 Gram Base/Vial, and 

ZEFAZONE (Cefmetazole Sodium) 

Intravenous Solution, Equivalent to 20 

Milligrams Base/Milliliter and 

Equivalent to 40 Milligrams Base/

Milliliter, Were Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that ZEFAZONE (cefmetazole sodium) 

Injection, equivalent to (EQ) 1 gram (g) 

base/vial and EQ 2 g base/vial, and 

ZEFAZONE (cefmetazole sodium) 

Intravenous (IV) Solution, EQ 20 

milligrams (mg) base/milliliter (mL) and 

EQ 40 mg base/mL, were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for 

ZEFAZONE (cefmetazole sodium) 

Injection, EQ 1 g base/vial and EQ 2 g 

base/vial, and ZEFAZONE (cefmetazole 

sodium) IV Solution, EQ 20 mg base/mL 

and 40 mg base/mL, if all other legal 

and regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Kathy Schreier, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6246, 

Silver Spring, MD 20993–0002, 301– 

796–3432. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the Orange 

Book. Under FDA regulations, drugs are 

removed from the list if the Agency 

withdraws or suspends approval of the 

drug’s NDA or ANDA for reasons of 

safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

ZEFAZONE (cefmetazole sodium) 

Injection, EQ 1 g base/vial and EQ 2 g 

base/vial, is the subject of NDA 50–637, 

held by Pharmacia & Upjohn, Inc., 

which was initially approved on 

December 11, 1989; and ZEFAZONE 

(cefmetazole sodium) IV Solution, EQ 

20 mg base/mL and EQ 40 mg base/mL, 

is the subject of NDA 50–683, held by 

Pharmacia & Upjohn, Inc., which was 

initially approved on December 29, 

1992. ZEFAZONE is a semisynthetic 

cephem antibiotic that is indicated for 

treatment of urinary tract infections, 

lower respiratory tract infections, skin 

and skin structure infections, and intraabdominal infections. 

In a letter dated August 1, 2000, 

Pharmacia & Upjohn, Inc., notified FDA 

that ZEFAZONE (cefmetazole sodium) 

Injection, EQ 1 g base/vial and EQ 2 g 

base/vial, and ZEFAZONE (cefmetazole 

sodium) IV Solution, EQ 20 mg base/mL 

and EQ 40 mg base/mL, were no longer 

being marketed and requested 

withdrawal of NDA 50–637 and NDA 

50–683. FDA moved the drug products 

to the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book and, in the 

Federal Register of August 16, 2001 (66 

FR 43017), announced that it was 

withdrawing approval of NDA 50–637 

and NDA 50–683 effective September 

17, 2001. 

Salus Pharma LLC submitted a citizen 

petition dated June 17, 2013 (Docket No. 

FDA–2013–P–0768), under 21 CFR 

10.30, requesting that the Agency 

determine whether ZEFAZONE 

(cefmetazole sodium) Injection, EQ 1 g 

base/vial and EQ 2 g base/vial, was 

withdrawn from sale for reasons of 

safety or effectiveness. Although the 

citizen petition did not request that we 

determine whether ZEFAZONE 

(cefmetazole sodium) IV Solution, EQ 

20 mg base/mL and EQ 40 mg base/mL, 

approved under NDA 50–683, was 

withdrawn for safety or effectiveness, 

that product also has been discontinued. 

On our own initiative, we have also 

determined whether ZEFAZONE 

(cefmetazole sodium) IV Solution, EQ 

20 mg base/mL and EQ 40 mg base/mL, 

was withdrawn for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that ZEFAZONE (cefmetazole 

sodium) Injection, EQ 1 g base/vial and 

EQ 2 g base/vial, and ZEFAZONE 

(cefmetazole sodium) IV Solution, EQ 

20 mg base/mL and EQ 40 mg base/mL, 

were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that ZEFAZONE 

(cefmetazole sodium) Injection, EQ 1 g 

base/vial and EQ 2 g base/vial, and 

ZEFAZONE (cefmetazole sodium) IV 

Solution, EQ 20 mg base/mL and EQ 40 

mg base/mL, were withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

ZEFAZONE (cefmetazole sodium) 

Injection, EQ 1 g base/vial and EQ 2 g 

base/vial, and ZEFAZONE (cefmetazole 

sodium) IV Solution, EQ 20 mg base/mL 

and EQ 40 mg base/mL, from sale. We 

have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that these products were 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list ZEFAZONE 

(cefmetazole sodium) Injection, EQ 1 g 

base/vial and EQ 2 g base/vial, and 

ZEFAZONE (cefmetazole sodium) IV 

Solution, EQ 20 mg base/mL and EQ 40 

mg base/mL, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 


emcdonald on DSK67QTVN1PROD with NOTICES