Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16393 

A contractor will also collect assault 

injury data from nursing home violent 

event reports three years pre-regulation 

(2009–2011) and three years postregulation (2012–2014). This data will 

be collected from existing OSHA logs; a 

NIOSH employee will fill out the 

Employee Incident Form from the 

OSHA logs received from the contractor. 

The purpose of collecting these data is 

to evaluate changes in assault injury 

rates before and after enactment of the 

regulations (Aim 2). The following 

information will be abstracted from the 

OSHA logs: Date, time and location of 

the incident; identity, job title and job 

task of the victim; identity of the 

perpetrator; description of the violent 

act, including whether a weapon was 

used; description of physical injuries; 

number of employees in the vicinity 

when the incident occurred, and their 

actions in response to the incident; 

recommendations of police advisors, 

employees or consultants, and; actions 

taken by the facility in response to the 

incident. No employee or perpetrator 

identifiable information will be 

collected. 

There are no costs to respondents 

other than their time. The total 

estimated burden hours are 120. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

esponse 

(in hours) 

Total burden 

(in hours) 

Nursing Home Administrator .................. Interview ...................................... 40 1 1 40 

Nursing Home Administrator .................. Abstraction Form ......................... 40 1 1 40 

Nursing Home Administrator .................. Employee Incident Form ............. 40 1 1 40 

Total ................................................ ..................................................... ........................ ........................ ........................ 120 

Leroy A. 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. 2015–07038 Filed 3–26–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health Statement 

of Organization, Functions, and 

Delegations of Authority 

Part N, National Institutes of Health 

(NIH), of the Statement of Organization, 

Functions, and Delegations of Authority 

for the Department of Health and 

Human Services (40 FR 22859, May 27, 

1975, as amended most recently at 77 

FR 1941, January 12, 2012, and 

redesignated from Part HN as Part N at 

60 FR 56605, November 9, 1995), is 

amended as set forth below to rename 

the National Center for Complementary 

and Alternative Medicine (NCCAM). 

Section N–D, Organization and 

Functions, under the heading National 

Center for Complementary and 

Alternative Medicine (NCCAM), is 

renamed to the National Center for 

Complementary and Integrative Health 

(NCCIH). 

Delegations of Authority Statement: 

All delegations and redelegations of 

authority to officers and employees of 

NIH that were in effect immediately 

prior to the effective date of this 

reorganization and are consistent with 

this reorganization shall continue in 

effect, pending further redelegation. 

Dated: March 20, 2015. 

Francis S. Collins, 

Director, NIH. 

[FR Doc. 2015–07064 Filed 3–26–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0114] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Request for 

Samples and Protocols 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection requirements 

relating to the regulations which state 

that protocols for samples of biological 

products must be submitted to the 

Agency. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 26, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: 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. 

‘‘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 provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

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16394 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Request for Samples and Protocols— 

(OMB Control Number 0910–0206)— 

Extension 

Under section 351 of the Public 

Health Service Act (42 U.S.C. 262), FDA 

has the responsibility to issue 

regulations that prescribe standards 

designed to ensure the safety, purity, 

and potency of biological products and 

to ensure that the biologics licenses for 

such products are only issued when a 

product meets the prescribed standards. 

Under 21 CFR 610.2, the Center for 

Biologics Evaluation and Research 

(CBER) or the Center for Drugs 

Evaluation and Research may at any 

time require manufacturers of licensed 

biological products to submit to FDA 

samples of any lot along with the 

protocols showing the results of 

applicable tests prior to distributing the 

lot of the product. In addition to § 610.2, 

there are other regulations that require 

the submission of samples and protocols 

for specific licensed biological products: 

21 CFR 660.6 (Antibody to Hepatitis B 

Surface Antigen); 21 CFR 660.36 

(Reagent Red Blood Cells); and 21 CFR 

660.46 (Hepatitis B Surface Antigen). 

Section 660.6(a) provides 

requirements for the frequency of 

submission of samples from each lot of 

Antibody to Hepatitis B Surface Antigen 

product, and § 660.6(b) provides the 

requirements for the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.6 products subject to official 

release by FDA, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

of manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After official release is no longer 

required, one sample along with a 

protocol is required to be submitted at 

90-day intervals. In addition, samples, 

which must be accompanied by a 

protocol, may at any time be required to 

be submitted to CBER if continued 

evaluation is deemed necessary. 

Section 660.36(a) requires, after each 

routine establishment inspection by 

FDA, the submission of samples from a 

lot of final Reagent Red Blood Cell 

product along with a protocol 

containing specific information. Section 

660.36(a)(2) requires that a protocol 

contain information including, but not 

limited to, manufacturing records, 

certain test records, and identity test 

results. Section 660.36(b) requires a 

copy of the antigenic constitution 

matrix specifying the antigens present 

or absent to be submitted to the CBER 

Director at the time of initial 

distribution of each lot. 

Section 660.46(a) contains 

requirements as to the frequency of 

submission of samples from each lot of 

Hepatitis B Surface Antigen product, 

and § 660.46(b) contains the 

requirements as to the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.46 products subject to official 

release by FDA, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

of manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After notification of official 

release is received, one sample along 

with a protocol is required to be 

submitted at 90-day intervals. In 

addition, samples, which must be 

accompanied by a protocol, may at any 

time be required to be submitted to 

CBER if continued evaluation is deemed 

necessary. 

Samples and protocols are required by 

FDA to help ensure the safety, purity, or 

potency of a product because of the 

potential lot-to-lot variability of a 

product produced from living 

organisms. In cases of certain biological 

products (e.g., Albumin, Plasma Protein 

Fraction, and therapeutic biological 

products) that are known to have lot-tolot consistency, official lot release is not 

normally required. However, 

submissions of samples and protocols of 

these products may still be required for 

surveillance, licensing, and export 

purposes, or in the event that FDA 

obtains information that the 

manufacturing process may not result in 

consistent quality of the product. 

The following burden estimate is for 

the protocols required to be submitted 

with each sample. The collection of 

samples is not a collection of 

information under 5 CFR 1320.3(h)(2). 

Respondents to the collection of 

information under § 610.2 are 

manufacturers of licensed biological 

products. Respondents to the collection 

of information under §§ 660.6(b), 

660.36(a)(2) and (b), and 660.46(b) are 

manufacturers of the specific products 

referenced previously in this document. 

The estimated number of respondents 

for each regulation is based on the 

annual number of manufacturers that 

submitted samples and protocols for 

biological products including 

submissions for lot release, surveillance, 

licensing, or export. Based on 

information obtained from FDA’s 

database system, approximately 80 

manufacturers submitted samples and 

protocols in fiscal year (FY) 2014, under 

the regulations cited previously in this 

document. FDA estimates that 

approximately 76 manufacturers 

submitted protocols under § 610.2 and 2 

manufacturers submitted protocols 

under the regulation (§ 660.6) for the 

other specific product. FDA received no 

submissions under § 660.36 or § 660.46, 

however FDA is using the estimate of 

one protocol submission under each 

regulation in the event that protocols are 

submitted in the future. 

The estimated total annual responses 

are based on FDA’s final actions 

completed in FY 2014 for the various 

submission requirements of samples 

and protocols for the licensed biological 

products. The average burden per 

response is based on information 

provided by industry. The burden 

estimates provided by industry ranged 

from 1 to 5.5 hours. Under § 610.2, the 

average burden per response is based on 

the average of these estimates and 

rounded to 3 hours. Under the 

remaining regulations, the average 

burden per response is based on the 

higher end of the estimate (rounded to 

5 or 6 hours) since more information is 

generally required to be submitted in 

the other protocols than under § 610.2. 

FDA estimates the burden of this 

information collection as follows: 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16395 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

610.2 Lot Release Information Submission .................................... 76 84 .54 6,197 3 18,591 

660.6(b) Lot Release Information Submission ................................ 2 9 18 5 90 

660.36(a)(2) and (b) Lot Release Information Submission ............. 1 1 1 6 6 

660.46(b) Lot Release Information Submission .............................. 1 1 1 5 5 

Total ............................................................................................ 80 .......................... 6,217 .................... 18,692 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: March 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07008 Filed 3–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3313–N] 

Announcement of the Re-Approval of 

the College of American Pathologists 

(CAP) as an Accreditation Organization 

Under the Clinical Laboratory 

Improvement Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the College of American 

Pathologists (CAP) for approval as an 

accreditation organization for clinical 

laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program. We have 

determined that the CAP meets or 

exceeds the applicable CLIA 

requirements. In this notice, we 

announce the approval and grant CAP 

deeming authority for a period of 6 

years. 

DATES: This notice is effective from 

March 27, 2015, until March 27, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Singer, 410–786–0365. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under these provisions, we 

may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements). Subpart 

E of part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption under an Approved State 

Laboratory Program) specifies the 

requirements an accreditation 

organization must meet to be approved 

by CMS as an accreditation organization 

under CLIA. 

II. Notice of Approval of CAP as an 

Accreditation Organization 

In this notice, we approve the College 

of American Pathologists (CAP) as an 

organization that may accredit 

laboratories for purposes of establishing 

their compliance with CLIA 

requirements in all specialties and 

subspecialties. We have examined the 

initial CAP application and all 

subsequent submissions to determine its 

accreditation program’s equivalency 

with the requirements for approval of an 

accreditation organization under 

subpart E of part 493. We have 

determined that the CAP meets or 

exceeds the applicable CLIA 

requirements. We have also determined 

that the CAP will ensure that its 

accredited laboratories will meet or 

exceed the applicable requirements in 

subparts H, I, J, K, M, Q, and the 

applicable sections of R. Therefore, we 

grant the CAP approval as an 

accreditation organization under 

subpart E of part 493, for the period 

stated in the DATES section of this notice 

for all specialties and subspecialties 

areas under CLIA. As a result of this 

determination, any laboratory that is 

accredited by the CAP during the time 

period stated in the DATES section of this 

notice will be deemed to meet the CLIA 

requirements for the listed specialties 

and subspecialties, and therefore, will 

generally not be subject to routine 

inspections by a state survey agency to 

determine its compliance with CLIA 

requirements. The accredited laboratory, 

however, is subject to validation and 

complaint investigation surveys 

performed by CMS, or its agent(s). 

III. Evaluation of the CAP Request for 

Approval as an Accreditation 

Organization Under CLIA 

The following describes the process 

used to determine that the CAP 

accreditation program meets the 

necessary requirements to be approved 

by CMS as an accreditation program 

with deeming authority under the CLIA 

program. The CAP formally applied to 

CMS for approval as an accreditation 

organization under CLIA for all 

specialties and subspecialties. In 

reviewing these materials, we reached 

the following determinations for each 

applicable part of the CLIA regulations: 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

The CAP submitted its mechanism for 

monitoring compliance with all 

requirements equivalent to conditionlevel requirements, a list of all its 

current laboratories and the expiration 

date of their accreditation, and a 

detailed comparison of the individual 

accreditation requirements with the 

comparable condition-level 

requirements. We have determined that 

the CAP’s policies and procedures for 

oversight of laboratories performing all 

laboratory testing covered by CLIA are 

equivalent to those required by our 

CLIA regulations in the matters of 

inspection, monitoring proficiency 

testing (PT) performance, investigating 

complaints, and making PT information 

available. The CAP submitted 

documentation regarding its 

requirements for monitoring and 

inspecting laboratories, and describing 

its own standards regarding 

accreditation removal or withdrawal of 

accreditation, notification requirements, 

and accreditation organization 

resources. We have determined that the 

requirements of the accreditation 

program submitted for approval are 

mstockstill on DSK4VPTVN1PROD with NOTICES