81 FR 79501 - Agency Information Collection: Comprehensive Child Welfare Information System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 81, Issue 219 (November 14, 2016)

Page Range		79501-79501
FR Document		2016-27280

Federal Register, Volume 81 Issue 219 (Monday, November 14, 2016)

[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Page 79501]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27280]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Agency Information Collection: Comprehensive Child Welfare 
Information System

Notice

    The Office of Management and Budget (OMB) has assigned approval 
number 0970-0463 to the Comprehensive Child Welfare Information System 
(CCWIS) Final Rule (81 FR 35450, published June 2, 2016) information 
collection. The CCWIS Final Rule describes an optional child welfare 
information system. States and tribes electing to build a CCWIS must 
collect and report certain information to the Administration for 
Children and Families regarding their CCWIS plans. The information 
collection described in the Final Rule includes:

 The automated function list (45 CFR 1355.52(i)(1)(ii)-(iii) 
and (i)(2))
 The data quality plan (45 CFR 1355.52(d)(5))
 The Notice of Intent (45 CFR 1355.52(i)(1))

    The authority for the information collection expires on 10/31/2019 
12:00:00 a.m.

    Authority: 42 U.S.C. 620 et seq., 42 U.S.C. 670 et seq.; 42 
U.S.C. 1301 and 1302.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016-27280 Filed 11-10-16; 8:45 am]
 BILLING CODE 4184-01-P

Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 79501

[FR Doc. 2016–27315 Filed 11–10–16; 8:45 am] product application. FDA bases this On or about August 30, 2007,
BILLING CODE 4120–01–C order on a finding that Mr. Manookian Melanocorp received a warning letter
was convicted of felonies under Federal from FDA expressing concern about
law for conduct relating to the Melanocorp’s marketing of MII. The
DEPARTMENT OF HEALTH AND regulation of a drug product under the warning letter noted that, based on
HUMAN SERVICES FD&C Act. Mr. Manookian was given information and statements on the
notice of the proposed permanent Melanocorp Web site, MII constituted a
Administration for Children and debarment and an opportunity to new drug under the FD&C Act that
Families request a hearing within the timeframe could not be introduced or delivered for
prescribed by regulation. Mr. introduction into interstate commerce
Agency Information Collection: without an FDA approved application.
Manookian failed to request a hearing.
Comprehensive Child Welfare The warning letter concluded that the
Mr. Manookian’s failure to request a
Information System sale of MII without an FDA approved
hearing constitutes a waiver of his right
Notice to a hearing concerning this action. application violated the FD&C Act and
DATES: This order is effective November instructed Mr. Manookian’s company to
The Office of Management and Budget take prompt action to correct the
(OMB) has assigned approval number 14, 2016.
ADDRESSES: Submit applications for
violations cited in the warning letter.
0970–0463 to the Comprehensive Child On or about September 17, 2007, after
Welfare Information System (CCWIS) special termination of debarment to the
consulting with counsel, Mr. Manookian
Final Rule (81 FR 35450, published June Division of Dockets Management (HFA–
sent a letter to FDA stating that
2, 2016) information collection. The 305), Food and Drug Administration,
Melanocorp had stopped all promotion
CCWIS Final Rule describes an optional 5630 Fishers Lane, Rm. 1061, Rockville,
and sale of MII in the United States and
child welfare information system. States MD 20852.
had stopped taking orders for MII from
and tribes electing to build a CCWIS FOR FURTHER INFORMATION CONTACT: U.S. residents.
must collect and report certain Kenny Shade, Division of Enforcement, On or about November 29, 2007, FDA
information to the Administration for Food and Drug Administration, 12420 sent a letter to an attorney representing
Children and Families regarding their Parklawn Dr. (ELEM–4144), Rockville, Melanocorp, which reiterated that MII
CCWIS plans. The information MD 20857, 301–796–4640. was considered by FDA to be an
collection described in the Final Rule SUPPLEMENTARY INFORMATION: unapproved drug and warned that its
includes: introduction or delivery for introduction
I. Background
• The automated function list (45 CFR into interstate commerce would be a
1355.52(i)(1)(ii)–(iii) and (i)(2)) Section 306(a)(2)(B) of the FD&C Act violation of the FD&C Act. The letter
• The data quality plan (45 CFR (21 U.S.C. 335a(a)(2)(B)) requires specifically stated that the sale of MII
1355.52(d)(5)) debarment of an individual if FDA finds outside of the United States violated the
• The Notice of Intent (45 CFR that the individual has been convicted FD&C Act.
1355.52(i)(1)) of a felony under Federal law for On or about December 14, 2007, Mr.
conduct relating to the regulation of any Manookian had a letter sent to FDA
The authority for the information
drug product under the FD&C Act. On from his attorney confirming that
collection expires on 10/31/2019
August 28, 2015, the U.S. District Court Melanocorp had stopped taking orders
12:00:00 a.m.
for the Middle District of Tennessee for MII from U.S. residents. This letter
Authority: 42 U.S.C. 620 et seq., 42 U.S.C. entered judgment against Mr. also stated that Melanocorp did not
670 et seq.; 42 U.S.C. 1301 and 1302. Manookian for two counts of conspiracy disagree that FDA considered MII to be
Robert Sargis, to commit an offense against the United an unapproved new drug, but Mr.
Reports Clearance Officer. States, in violation of 18 U.S.C. 371. Manookian’s position was that
FDA’s finding that the debarment is Melanocorp could lawfully export MII,
[FR Doc. 2016–27280 Filed 11–10–16; 8:45 am]
appropriate is based on the felony regardless of its status as an unapproved
BILLING CODE 4184–01–P
convictions referenced herein. The new drug.
factual basis for these convictions is as On or about December 28, 2007, FDA
DEPARTMENT OF HEALTH AND follows: Mr. Manookian was the sent a letter to Mr. Manookian’s attorney
HUMAN SERVICES President and owner of Melanocorp, which reiterated that unapproved new
Inc. (Melanocorp), a for-profit drugs do not qualify for export.
Food and Drug Administration corporation that conducted operations Following receipt of the December 28,
in the Middle District of Tennessee, and 2007, correspondence from FDA,
[Docket No. FDA–2015–N–4169] his duties included overseeing the Melanocorp continued to ship MII in
Edward Manookian (Also Known as Ed employees and operations of interstate commerce. Melanocorp
Manning): Debarment Order Melanocorp. primarily sold MII to customers located
Melanotan II (MII) was a peptide, or abroad, but also shipped MII
AGENCY: Food and Drug Administration, series of amino acids, that was domestically on a more limited basis.
HHS. marketed, sold, and shipped by From on or about September 17, 2007,
ACTION: Notice. Melanocorp to customers in the United and continuing through in or about
States and abroad. Mr. Manookian’s April 2009, Mr. Manookian conspired
SUMMARY: The U.S. Food and Drug company advertised MII, an unapproved with others to defraud the United States
mstockstill on DSK3G9T082PROD with NOTICES

Administration (FDA or Agency) is new drug, as an injectable tanning by causing Melanocorp to ship MII to
issuing an order under the Federal product through an internet Web site. customers in the United States despite
Food, Drug, and Cosmetic Act (the The Melanocorp Web site also telling FDA that Melanocorp would not
FD&C Act) permanently debarring advertised MII as being 100 percent U.S. distribute or market MII in the United
Edward Manookian from providing made, whereas in fact some of the MII States.
services in any capacity to a person that sold by Melanocorp was manufactured As a result of these convictions, FDA
has an approved or pending drug in and imported from China. sent Mr. Manookian by certified mail on

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		81 FR 79501

81 FR 79501 - Agency Information Collection: Comprehensive Child Welfare Information System

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 81, Issue 219 (November 14, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families