Federal Register / Vol. 80, No. 9 / Wednesday, January 14, 2015 / Notices 1917 

9. The response time with respect to the 

provision of services to families and 

children where an allegation of 

child abuse or neglect has been 

made. 

10. For child protective service 

personnel responsible for intake, 

screening, assessment, and 

investigation of child abuse and 

neglect reports in the State— 

A. information on the education, 

qualifications, and training 

requirements established by the 

State for child protective service 

professionals, including for entry 

and advancement in the profession, 

including advancement to 

supervisory positions; 

B. data of the education, 

qualifications, and training of such 

personnel; 

C. demographic information of the 

child protective service personnel; 

and 

D. information on caseload or 

workload requirements for such 

personnel, including requirements 

for average number and maximum 

number of cases per child 

protective service worker and 

supervisor. 

11. The number of children reunited 

with their families or receiving 

family preservation services that, 

within five years, result in 

subsequent substantiated reports of 

child abuse or neglect, including 

the death of the child. 

12. The number of children for whom 

individuals were appointed by the 

court to represent the best interests 

of such children and the average 

number of out of court contacts 

between such individuals and 

children. 

13. The annual report containing the 

summary of activities of the citizen 

review panels of the State required 

by subsection (c)(6). 

14. The number of children under the 

care of the State child protection 

system who are transferred into the 

custody of the State juvenile justice 

system. 

15. The number of children referred to 

a child protective services system 

under subsection (b)(2)(B)(ii). 

16. The number of children determined 

to be eligible for referral, and the 

number of children referred, under 

subsection (b)(2)(B)(xxi), to agencies 

providing early intervention 

services under part C of the 

Individuals with Disabilities 

Education Act (20 U.S.C. 1431 et 

seq.). 

The Children’s Bureau proposes to 

continue collecting the NCANDS data 

through the two files of the Detailed 

Case Data Component, the Child File 

(the case-level component of NCANDS) 

and the Agency File (additional 

aggregate data, which cannot be 

collected at the case level). Technical 

assistance will be provided so that all 

States may provide the Child File and 

Agency File data to NCANDS. 

There are no proposed changes to the 

NCANDS data collection instruments. 

New fields were implemented during 

the previous OMB clearance cycle in 

support of the CAPTA Reauthorization 

Act of 2010 and to improve reporting on 

federal performance measures. 

Respondents: State governments, the 

District of Columbia, and the 

Commonwealth of Puerto Rico. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Detailed Case Data Component Child File and Agency File .......................... 52 1 82 4,264 

Estimated Total Annual Burden 

Hours: 4,264. 

In compliance with the requirements 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information may be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–00081 Filed 1–13–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1951] 

CHEMBIOMED, LTD., Opportunity for a 

Hearing on a Proposal To Revoke U.S. 

License No. 0916 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for a hearing on a proposal 

to revoke the biologics license (U.S. 

License No. 0916) issued to 

CHEMBIOMED, LTD. (CHEMBIOMED), 

for the manufacture of Anti-A (Murine 

Monoclonal), Anti-B (Murine 

Monoclonal), Anti-Lea (Murine 

Monoclonal) and Anti-Leb (Murine 

Monoclonal). The proposed revocation 

is based on information that the firm is 

no longer in operation and the 

manufacture of its licensed products has 

been discontinued. 

DATES: CHEMBIOMED may submit 

electronic or written requests for a 

hearing by February 13, 2015, and any 

data and information justifying a 

hearing by March 16, 2015. Other 

interested persons may submit 

electronic or written comments on the 

proposed revocation by March 16, 2015. 

ADDRESSES: Submit electronic requests 

for a hearing, any data and information 

justifying a hearing, and comments to 

http://www.regulations.gov. Submit 

written requests for a hearing, any data 

and information justifying a hearing, 

mstockstill on DSK4VPTVN1PROD with NOTICES

1918 Federal Register / Vol. 80, No. 9 / Wednesday, January 14, 2015 / Notices 

and any written comments on the 

proposed revocation to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: John 

Reilly, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is initiating proceedings to 

revoke the biologics license (U.S. 

License No. 0916) issued to 

CHEMBIOMED, 9515 107th St., Rm. 

401, Edmonton AB T5K 2C3, Canada, 

for the manufacture of Anti-A (Murine 

Monoclonal), Anti-B (Murine 

Monoclonal), Anti-Lea (Murine 

Monoclonal) and Anti-Leb (Murine 

Monoclonal). Proceedings to revoke U.S. 

License No. 0916 are being initiated 

under 21 Code of Federal Regulations 

(CFR) 601.5(b) because FDA has 

determined through various means that 

a meaningful inspection of 

CHEMBIOMED cannot be conducted 

because the manufacturer is no longer in 

operation. In addition, Health Canada 

has advised FDA that CHEMBIOMED is 

no longer in operation. According to the 

Industry Canada Web site 

(www.ic.gc.ca), CHEMBIOMED 

(Corporation No. 0228176 and Business 

No. (BN) 100938521RC0001 under the 

governing legislation of the Canada 

Business Corporations Act) was issued a 

Certificate of Incorporation on August 

15, 1977, and later was issued a 

Certificate of Dissolution on March 17, 

1999. 

In a phone conversation that occurred 

on July 7, 1992, a former CHEMBIOMED 

employee informed FDA that 

CHEMBIOMED was no longer in 

business, had ceased the manufacture of 

licensed products, and had also ceased 

shipments of licensed products to the 

United States. 

In a letter dated June 16, 1995, FDA 

requested from the Authorized Official 

(Responsible Head) of CHEMBIOMED a 

status update for the production of all 

of the products for which 

CHEMBIOMED held a U.S. license. This 

letter requested that the firm notify FDA 

in writing of the firm’s status and also 

informed the Authorized Official that in 

the absence of a response to this letter 

that FDA would take action to revoke 

CHEMBIOMED’s U.S. license. FDA did 

not receive a response to its letter dated 

June 16, 1995. 

In a certified, return-receipt letter 

dated October 18, 1995, FDA requested 

that the Authorized Official of 

CHEMBIOMED inform FDA whether or 

not the firm intended to pursue a 

product license application supplement 

request dated May 6, 1987. In the 

October 18, 1995 letter, FDA also 

informed the Authorized Official that 

the product license application 

supplement request had been placed in 

the FDA inactive files. FDA did not 

receive a response to its certified, 

return-receipt letter dated October 18, 

1995. 

In a letter to CHEMBIOMED dated 

December 19, 2012, FDA provided 

notice of FDA’s intent to revoke U.S. 

License No. 0916 and announced its 

intent to offer an opportunity for a 

hearing. FDA indicated that FDA 

registrations for CHEMBIOMED 

facilities have not been updated since 

May 12, 1994. The letter also advised 

the Authorized Official that, under 21 

CFR 601.5(b)(1)(i) and (ii) of FDA’s 

regulations, proceedings for license 

revocation may be instituted when FDA 

finds that authorized FDA employees 

have been unable to gain access to an 

establishment for the purpose of 

carrying out an inspection, or when the 

manufacturing of a product has been 

discontinued to an extent that a 

meaningful inspection cannot be made. 

The December 19, 2012 letter to 

CHEMBIOMED, sent via United Parcel 

Service (UPS), was returned as 

undeliverable. 

II. Notice of Opportunity for Hearing 

Because FDA has made reasonable 

efforts to notify CHEMBIOMED of the 

proposed revocation and no response 

has been received from the firm, FDA is 

proceeding under 21 CFR 12.21(b) and 

issuing this notice of opportunity for a 

hearing on a proposal to revoke the 

biologics license (US. License No. 0916) 

issued to CHEMBIOMED for the 

manufacture of Anti-A (Murine 

Monoclonal), Anti-B (Murine 

Monoclonal), Anti-Lea (Murine 

Monoclonal) and Anti-Leb (Murine 

Monoclonal). 

FDA has placed copies of the 

documents relevant to the proposed 

revocation on file with the Division of 

Dockets Management (see ADDRESSES) 

under the docket number found in 

brackets in the heading of this notice. 

These documents include the following: 

(1) A phone conversation record dated 

July 7, 1992 between FDA and a former 

CHEMBIOMED employee; (2) an FDA 

letter to the Authorized Official of 

CHEMBIOMED dated June 16, 1995; (3) 

a certified, return-receipt letter from 

FDA to the Authorized Official of 

CHEMBIOMED dated October 18, 1995; 

(4) a UPS Express Mail, signature 

required letter from FDA to the 

Authorized Official of CHEMBIOMED, 

dated December 19, 2012, and returned 

as undeliverable; and (5) Industry 

Canada information that documents 

CHEMBIOMED, Corporation No. 

0228176 and BN 100938521RC0001 

under the governing legislation of the 

Canada Business Corporations Act, was 

issued a Certificate of Incorporation on 

August 15, 1977, and later was issued a 

Certificate of Dissolution on March 17, 

1999. These documents are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

CHEMBIOMED may submit an 

electronic or written request for a 

hearing to the Division of Dockets 

Management by February 13, 2015, and 

any data and information justifying a 

hearing to the Division of Dockets 

Management by March 16, 2015. Other 

interested persons may submit 

electronic or written comments on the 

proposed license revocation to the 

Division of Dockets Management by 

March 16, 2015. The failure of the 

licensee, CHEMBIOMED, to file a timely 

electronic or written request for a 

hearing constitutes an election by the 

licensee not to avail itself of the 

opportunity for a hearing concerning the 

proposed license revocation (§ 12.22(b)). 

FDA’s procedures and requirements 

governing a notice of opportunity for a 

hearing, notice of appearance and 

request for a hearing, grant or denial of 

a hearing, and submission of data and 

information to justify a hearing on a 

proposed revocation of a license are 

contained in 21 CFR parts 12 and 601. 

A request for a hearing may not rest on 

mere allegations or denials, but must set 

forth a genuine and substantial issue of 

fact that requires a hearing (§ 12.24(b)). 

If it conclusively appears from the face 

of the data, information, and factual 

analyses submitted in support of the 

request for a hearing that there is no 

genuine and substantial issue of fact for 

resolution at a hearing, the 

Commissioner of Food and Drugs (the 

Commissioner) will deny the hearing 

request, making findings and 

conclusions that justify the denial 

(§ 12.24(b)(3)). 

Only one copy of any submission 

need be provided to FDA. Submissions 

are to be identified with the docket 

number found in brackets in the 

heading of this document. Such 

submissions, except for data and 

information prohibited from public 

disclosure under 21 CFR 10.20(j)(2)(i), 

21 U.S.C. 331(j) or 18 U.S.C. 1905, may 

be examined in the Division of Dockets 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 9 / Wednesday, January 14, 2015 / Notices 1919 

Management (see ADDRESSES) between 9 

a.m. and 4 p.m., Monday through Friday 

and will be posted to the docket at 

http://www.regulations.gov. 

This notice is issued under section 

351 of the Public Health Service Act (42 

U.S.C. 262) and sections 201, 501, 502, 

505, and 701 of the Federal Food, Drug, 

and Cosmetic Acts (21 U.S.C. 321, 351, 

352, 355, and 371), and under the 

authority delegated to the Commissioner 

and redelegated to the Director and 

Deputy Director of the Center for 

Biologics Evaluation and Research (FDA 

Staff Manual Guide 1410.203). 

Dated: January 9, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00442 Filed 1–13–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Determining Mental Health 

Professional Shortage Areas of 

Greatest Need 

AGENCY: Health Resources and Services 

Administration (HRSA), Health and 

Human Services (HHS). 

ACTION: updating of the scoring criteria 

for determining mental health 

professional shortage areas (HPSA) of 

greatest need. 

SUMMARY: In accordance with the 

requirements of section 333A(b)(1) of 

the Public Health Service (PHS) Act, as 

amended by the Health Care Safety Net 

Amendments of 2002, 42 U.S.C. 254f1(b)(1), the Secretary of HHS shall 

establish the criteria which she will use 

to make determinations under section 

333A(a)(1)(A) of the HPSAs with the 

greatest shortages. This notice sets forth 

revised criteria for determining mental 

health HPSAs with the greatest shortage. 

This updates the previous criteria 

published on May 30, 2003. 

DATES: Effective January 14, 2015. 

FOR FURTHER INFORMATION CONTACT: Kae 

Brickerd, Ph.D., Chief, Shortage 

Designation Branch, Bureau of Health 

Workforce, Division of Policy and 

Shortage Designation, Health Resources 

and Services Administration, 11W14 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857, 301 945– 

0828, kbrickerd@hrsa.gov. 

SUPPLEMENTARY INFORMATION: Section 

332 of the PHS Act, 42 U.S.C. 254e, 

provides that the Secretary shall 

designate HPSAs based on criteria 

established by regulation. HPSAs are 

defined in Section 332 to include (1) 

urban and rural geographic areas with 

shortages of health professionals, (2) 

population groups with such shortages, 

and (3) facilities with such shortages. 

The required regulations setting forth 

the criteria for designating HPSAs are 

codified at 42 CFR part 5. Section 

333A(a)(1)(A) of the PHS Act and 

requires that the Secretary give priority 

in the assignment of National Health 

Service Corps personnel to entities 

serving HPSAs with the greatest health 

professional shortage. Section 333A(b) 

of the PHS Act requires that the 

Secretary establish criteria specifying 

the manner in which she determines 

HPSAs of greatest shortage and publish 

the criteria, and any revisions to the 

criteria, in the Federal Register. The 

criteria established by the Secretary 

create a method for scoring HPSAs 

based on relative shortage. 

In the Federal Register notice on May 

30, 2003, 68 FR 32531, the following 

criteria were identified for determining 

scores for mental health HPSAs: 

population to provider ratio, percentage 

of the population below 100 percent of 

poverty, travel time to the nearest 

alternative source of care, the ratio of 

children under age 18 to adults age 18– 

64, the ratio of adults over age 65 to 

adults age 18–64, and alcohol and 

substance abuse prevalence rates. Each 

factor is given points and the score is 

the sum of the points, up to 25. This 

notice modifies and provides 

clarification to the point scale for the 

population to provider ratio component 

of the formula, based on an assessment 

that the current point scale for the 

population to provider ratio does not 

adequately reflect the level of shortage. 

As a result of the modifications, the 

point values assigned for some 

population to provider ratios will see 

either a small increase or decrease, 

while others may remain unchanged. 

All other scoring criteria and point 

scales remain the same as published in 

the previous notice. 

The point scale published in 2003 for 

the population to provider ratio is 

presented in the following table: 

Psychiatrist ratio Core mental health ratio Score 

>45,000:0 AND .............................................................................. >4,500:0 ....................................................................................... 8 

>4500:1 and <6000:11 ................................................................. 7 

<20,000:1 and >15,000:1 AND ..................................................... >6000:1 and <9,000:1 ................................................................. 6 

<30,000:1 and >15,000:1 OR ....................................................... >4,500:1 and <6,000:1 ................................................................ 5 

<45,000:1 and > 20,000:1 AND .................................................... >4,500:0 and <6,000:0 ................................................................ 4 

>20,000:1 AND .............................................................................. >6,000:1 ....................................................................................... 3 

>30,000:1 ...................................................................................... ...................................................................................................... 2 

>9,000:1 ....................................................................................... 1 

1 > = Greater Than; < = Less Than 

To reflect the mental health services 

available in a community, entities 

applying for Mental Health HPSAs are 

encouraged to report on the number of 

both psychiatrists and core mental 

health providers rendering services. The 

revised point scale is as follows: 

For Geographic High Need and 

Population HPSAs, as defined in the 

designation criteria set forth in 42 CFR 

part 5, Appendix C, Part 1, and A.4. 

BILLING CODE 4165–15–P 

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