83 FR 39100 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 153 (August 8, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 153 (August 8, 2018)
| Page Range | 39100-39102 | |
| FR Document | 2018-16947 |
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)] [Notices] [Pages 39100-39102] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16947] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-18-1072] Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Enhanced STD surveillance Network (SSuN) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ``Proposed Data Collection Submitted for Public Comment and Recommendations'' notice on March, 15, 2018 to obtain comments from the public and affected agencies. CDC received 37 comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication. Proposed Project Enhanced STD surveillance Network (SSuN)--Reinstatement with Change--Division of STD Prevention (DSTDP), National Center for HIV/ AIDS, Viral Hepatitis, STD, and TB prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Enhanced STD surveillance network project was created to provide enhanced behavioral, demographic, and clinical information on gonorrhea cases reported to state and local health departments, to provide information on patients presenting for care in STD clinical settings, and to provide an infrastructure for identifying emerging sequelae of STDs. Enhanced SSuN continues to be a collaboration between different branches of the CDC Division of STD Prevention and selected state/local public health departments and their associated STD specialty care clinics in the US. Data from enhanced SSuN data is used to (1) provide a dataset of supplemental information on gonorrhea case reports; (2) provide geographic information on case reports of STDs of interest for investigating social determinants of STDs, (3) monitor STD screening, incidence, prevalence, epidemiologic and health care access trends in populations of interest, (4) monitor STD treatment and prevention service practices, and (5) monitor selected adverse health outcomes of STDs, including neuro/ocular syphilis, This project will continue to utilize two distinct surveillance strategies to collect information. The first strategy employs facility- based sentinel surveillance, which will abstract routine standardized data from existing electronic medical records for all patient visits to participating STD clinics during the project period. For the facility- based component of enhanced SSuN, participating sites have developed common protocols stipulating data elements to be collected, including patient demographics, clinical, risk and sexual behaviors. The specified data elements are abstracted by clinic staff from [[Page 39101]] existing electronic medical records for all patient visits to participating STD clinics. Some of the participating facilities are satellite clinics of large network providers where clinical data systems are centralized. Hence, there are 10 unique clinic data managers that will be abstracting the facility data. Each of the clinic data managers will spend three hours to extract and transmit data to local/state health departments. Individual patient records are de- identified (all patient-specific identifiers are removed) by clinic staff before being transmitted to health departments, who recode the data into standardized formats before being transmitted to CDC through secure file transport mechanisms. Each enhanced SSuN site will spend 16 hours to recode and transmit the data to CDC every other month. At CDC, data will be aggregated across all participating sites in a common data structure and formatted for analysis. Under this revision, the second strategy, population-based STD surveillance is being expanded to include not only a random sample of reported gonorrhea cases but also include patients diagnosed with early syphilis that report neurologic/ocular manifestations. For the gonorrhea population component, a probability sample of gonorrhea cases (up to 10% of total gonorrhea morbidity for participating jurisdictions) will be contacted by health department staff for a standardized interview either by phone or in-person. Enhanced gonorrhea investigations will also include verification of treatment and an internal health department record review (performed on either all cases or on the sampled cases). The focus of the new population activity focuses on obtaining additional clinical information on early syphilis cases who report neurologic/ocular symptoms. The subset of patients reporting these symptoms are asked to participate in an interview to obtain additional clinical information for a more complete assessment of neurologic/ocular involvement as well as obtain additional clinical information from the diagnosing or reporting provider. Lastly, early syphilis cases reporting neurologic and/or ocular symptoms are recontacted at approximately three months following prescribed treatment to ascertain whether initial symptoms have resolved. The population data will be directly entered into existing STD surveillance information systems at each health department. Data will be locally extracted, de-identified and recoded into standardized formats prior to being transmitted to CDC through secure file transport mechanisms on bimonthly basis. Patient participation in the interview is voluntary and refusal to participate has no impact on other STD services the health department provides to persons diagnosed with gonorrhea. This project will not collect name, social security number, or date of birth. A Patient ID, a unique patient identifier assigned by the clinic or health department depending on the component, is requested and will be provided to CDC for purposes of enhanced surveillance. Patient IDs are not linkable across enhanced SSuN components. Sensitive information such as sex of sex partners, HIV status, sex work exposure, and injection drug use are collected. All personally identifiable information (PII) is retained by the STD clinics and/or health departments and is not recorded with data sent to CDC. The electronic enhanced SSuN database is stored on the CDC mainframe computer and only approved Division of STD Prevention (DSTDP) staff have access rights to the data. As part of the revision, we will continue to systematically identify the risks and potential effects of collecting, maintaining, and disseminating PII and to examine and evaluate alternative processes for handling that information to mitigate potential privacy risks and risks to confidentiality. Both components of enhanced SSuN are designed to (1) Integrate traditional surveillance methods with innovative data management technologies to produce high-quality, timely surveillance and epidemiologic data, (2) provide valuable information to direct public health STD prevention and control efforts, (3) enhance understanding of the community burden of disease, (4) identify syndemic patterns and population at greatest risk, and, (5) monitor long-term health consequences of STDs. The enhanced SSuN surveillance platform allows CDC to establish and maintain common standards for data collection, transmission, and analysis, and to build and maintain STD surveillance expertise in 10 state/local health departments. Such common systems, established mechanisms of communication, and in-place expertise are all critical components for timely, flexible, and high quality surveillance. The total estimated annual burden is 3,479 hours. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Data manager at Sentinel STD clinics.. Record Abstraction...... 10 6 3 General Public--Adults (persons Interview............... 5492 1 10/60 diagnosed and reported with gonorrhea or early syphilis. Diagnosing Provider................... Data for early syphilis 406 1 10/60 cases. General Public--Adults (persons with 3 month follow-up 203 1 5/60 early syphilis who were reported with telephone Interview. neurologic/ocular manifestations. Data Managers: 10 local/state health Data cleaning/validation/ 10 12 19 department. reformatting. ---------------------------------------------------------------------------------------------------------------- [[Page 39102]] Jeffrey M. Zirger, Acting 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. 2018-16947 Filed 8-7-18; 8:45 am] BILLING CODE 4163-18-P
![39100 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
comment does not include any sensitive Privacy Act, see https://www.ftc.gov/ of the information collection plan and
or confidential information. In site-information/privacy-policy. instruments, call (404) 639–7570 or
particular, your comment should not send an email to omb@cdc.gov. Direct
Heather Hippsley,
include any sensitive personal written comments and/or suggestions
Acting Principal Deputy General Counsel. regarding the items contained in this
information, such as your or anyone
[FR Doc. 2018–16936 Filed 8–7–18; 8:45 am] notice to the Attention: CDC Desk
else’s Social Security number; date of
birth; driver’s license number or other BILLING CODE 6750–01–P Officer, Office of Management and
state identification number, or foreign Budget, 725 17th Street NW,
country equivalent; passport number; Washington, DC 20503 or by fax to (202)
DEPARTMENT OF HEALTH AND 395–5806. Provide written comments
financial account number; or credit or
HUMAN SERVICES within 30 days of notice publication.
debit card number. You are also solely
responsible for making sure that your Centers for Disease Control and Proposed Project
comment does not include any sensitive Prevention Enhanced STD surveillance Network
health information, such as medical (SSuN)—Reinstatement with Change—
[30Day–18–1072]
records or other individually Division of STD Prevention (DSTDP),
identifiable health information. In Agency Forms Undergoing Paperwork National Center for HIV/AIDS, Viral
addition, your comment should not Reduction Act Review Hepatitis, STD, and TB prevention
include any ‘‘trade secret or any (NCHHSTP), Centers for Disease Control
commercial or financial information In accordance with the Paperwork and Prevention (CDC).
which . . . is privileged or Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC) Background and Brief Description
confidential’’—as provided by Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and has submitted the information The Enhanced STD surveillance
collection request titled Enhanced STD network project was created to provide
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
surveillance Network (SSuN) to the enhanced behavioral, demographic, and
including in particular competitively
Office of Management and Budget clinical information on gonorrhea cases
sensitive information such as costs, reported to state and local health
(OMB) for review and approval. CDC
sales statistics, inventories, formulas, departments, to provide information on
previously published a ‘‘Proposed Data
patterns, devices, manufacturing Collection Submitted for Public patients presenting for care in STD
processes, or customer names. Comment and Recommendations’’ clinical settings, and to provide an
Comments containing material for notice on March, 15, 2018 to obtain infrastructure for identifying emerging
which confidential treatment is comments from the public and affected sequelae of STDs.
requested must be filed in paper form, agencies. CDC received 37 comments Enhanced SSuN continues to be a
must be clearly labeled ‘‘Confidential,’’ related to the previous notice. This collaboration between different
and must comply with FTC Rule 4.9(c). notice serves to allow an additional 30 branches of the CDC Division of STD
In particular, the written request for days for public and affected agency Prevention and selected state/local
confidential treatment that accompanies comments. public health departments and their
the comment must include the factual CDC will accept all comments for this associated STD specialty care clinics in
proposed information collection project. the US. Data from enhanced SSuN data
and legal basis for the request, and must
The Office of Management and Budget is used to (1) provide a dataset of
identify the specific portions of the
is particularly interested in comments supplemental information on gonorrhea
comment to be withheld from the public
that: case reports; (2) provide geographic
record. See FTC Rule 4.9(c). Your information on case reports of STDs of
(a) Evaluate whether the proposed
comment will be kept confidential only interest for investigating social
collection of information is necessary
if the General Counsel grants your determinants of STDs, (3) monitor STD
for the proper performance of the
request in accordance with the law and functions of the agency, including screening, incidence, prevalence,
the public interest. Once your comment whether the information will have epidemiologic and health care access
has been posted on the public FTC practical utility; trends in populations of interest, (4)
website—as legally required by FTC (b) Evaluate the accuracy of the monitor STD treatment and prevention
Rule 4.9(b)—we cannot redact or agencies estimate of the burden of the service practices, and (5) monitor
remove your comment from the FTC proposed collection of information, selected adverse health outcomes of
website, unless you submit a including the validity of the STDs, including neuro/ocular syphilis,
confidentiality request that meets the methodology and assumptions used; This project will continue to utilize
requirements for such treatment under (c) Enhance the quality, utility, and two distinct surveillance strategies to
FTC Rule 4.9(c), and the General clarity of the information to be collect information. The first strategy
Counsel grants that request. collected; employs facility-based sentinel
(d) Minimize the burden of the surveillance, which will abstract routine
The FTC Act and other laws that the
collection of information on those who standardized data from existing
Commission administers permit the
are to respond, including, through the electronic medical records for all patient
collection of public comments to visits to participating STD clinics
use of appropriate automated,
consider and use in this proceeding as during the project period. For the
electronic, mechanical, or other
appropriate. The Commission will facility-based component of enhanced
sradovich on DSK3GMQ082PROD with NOTICES
technological collection techniques or
consider all timely and responsive other forms of information technology, SSuN, participating sites have
public comments that it receives on or e.g., permitting electronic submission of developed common protocols
before October 9, 2018. For information responses; and stipulating data elements to be
on the Commission’s privacy policy, (e) Assess information collection collected, including patient
including routine uses permitted by the costs. demographics, clinical, risk and sexual
To request additional information on behaviors. The specified data elements
the proposed project or to obtain a copy are abstracted by clinic staff from
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![39102 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
Jeffrey M. Zirger, ACTION: Notice. SUPPLEMENTARY INFORMATION: The
Acting Chief, Information Collection Review holders of the applications listed in the
Office, Office of Scientific Integrity, Office SUMMARY: The Food and Drug
table have informed FDA that these drug
of the Associate Director for Science, Office Administration (FDA or Agency) is
products are no longer marketed and
of the Director, Centers for Disease Control withdrawing approval of 27 abbreviated
and Prevention. new drug applications (ANDAs) from have requested that FDA withdraw
[FR Doc. 2018–16947 Filed 8–7–18; 8:45 am] multiple applicants. The holders of the approval of the applications under the
applications notified the Agency in process described in § 314.150(c) (21
BILLING CODE 4163–18–P
writing that the drug products were no CFR 314.150(c)). The applicants have
longer marketed and requested that the also, by their requests, waived their
DEPARTMENT OF HEALTH AND approval of the applications be opportunity for a hearing. Withdrawal
HUMAN SERVICES withdrawn. of approval of an application or
abbreviated application under
DATES: Approval is withdrawn as of
Food and Drug Administration § 314.150(c) is without prejudice to
September 7, 2018.
[Docket No. FDA–2018–N–2485] refiling.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
Fougera Pharmaceuticals, Inc., et al.;
and Research, Food and Drug
Withdrawal of Approval of 27
Administration, 10903 New Hampshire
Abbreviated New Drug Applications
Ave., Bldg. 75, Rm. 1671, Silver Spring,
AGENCY: Food and Drug Administration, MD 20993–0002, 240–402–7945,
HHS. Trang.Tran@fda.hhs.gov.
Application No. Drug Applicant
ANDA 061467 ......... Pyocidin-Otic (hydrocortisone and polymyxin B sulfate) Otic Solution, 5 milli- Fougera Pharmaceuticals, Inc., 60
grams (mg)/10,000 units per milliliter (mL). Baylis Rd., P.O. Box 2006, Melville,
NY 11747.
ANDA 061653 ......... Tetrex (tetracycline phosphate complex) Capsules, Equivalent to (EQ) 100 mg Bristol-Myers Squibb Co., P.O. Box
Hydrochloride (HCl), EQ 250 mg HCl and EQ 500 mg HCl. 4000, Princeton, NJ 08543.
ANDA 061658 ......... Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ........................... Do.
ANDA 061711 ......... Penicillin V Potassium Tablets .............................................................................. Do.
ANDA 061721 ......... Ampicillin Capsules, 250 mg and 500 mg ............................................................. Do.
ANDA 061726 ......... Azotrex (phenazopyridine HCl, sulfamethizole and tetracycline phosphate com- Do.
plex) Capsules, 50 mg/250 mg/125 mg.
ANDA 061790 ......... Hetacillin Potassium ............................................................................................... Do.
ANDA 061887 ......... Bristamycin (erythromycin stearate) Tablets, EQ 250 mg base ........................... Do.
ANDA 061888 ......... Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ........................... Do.
ANDA 061889 ......... Tetrex (tetracycline phosphate complex) Capsules, EQ 250 mg HCl and EQ Do.
500 mg HCl.
ANDA 061890 ......... Azotrex (phenazopyridine HCl, sulfamethizole, and tetracycline) Capsules, 50 Do.
mg/250 mg/125 mg.
ANDA 061891 ......... Tetrex-S (tetracycline) Syrup, 125 mg/5 mL ......................................................... Do.
ANDA 061975 ......... Cephradine Powder for Injection ........................................................................... Do.
ANDA 062168 ......... Cephradine Tablets ................................................................................................ Do.
ANDA 062259 ......... Amphotericin B for Use in Parenteral Products .................................................... Do.
ANDA 062543 ......... Mycolog (nystatin, neomycin sulfate, gramicidin, and triamcinolone acetonide) Do.
Ointment.
ANDA 071793 ......... Foamcoat (aluminum hydroxide; magnesium trisilicate) Chewable Tablets, 80 Guardian Drug Co., 2 Charles Court,
mg/20 mg (OTC). Dayton, NJ 08810.
ANDA 072035 ......... Nuprin (ibuprofen) Tablets, 200 mg ....................................................................... Bristol-Myers Squibb Co.
ANDA 072036 ......... Nuprin (ibuprofen) Tablets, 200 mg ....................................................................... Do.
ANDA 074911 ......... Phrenilin with Caffeine and Codeine (acetaminophen, butalbital, caffeine, and Valeant Pharmaceuticals North Amer-
codeine phosphate) Capsules, 325 mg/50 mg/40 mg/30 mg. ica, LLC, 400 Somerset Corporate
Blvd., Bridgewater, NJ 08807.
ANDA 074944 ......... Atracurium Besylate Injection, 10 mg/mL .............................................................. Watson Laboratories, Inc., Subsidiary
of Teva Pharmaceuticals USA, Inc.,
425 Privet Rd., Horsham, PA 19044.
ANDA 075206 ......... Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram (g)/ Teva Pharmaceuticals USA, Inc., 425
vial, and 2 g/vial. Privet Rd., Horsham, PA 19044.
ANDA 077337 ......... Rosiglitazone Maleate and Metformin HCl Tablets, EQ 1 mg base/500 mg, EQ Do.
2 mg base/500 mg, EQ 4 mg base/500 mg, EQ 2 mg base/1 g, and EQ 4 mg
base/1 g.
ANDA 077930 ......... Meloxicam Tablets, 7.5 mg and 15 mg ................................................................. Impax Laboratories, Inc., 30831
Huntwood Ave., Hayward, CA 94544.
ANDA 080658 ......... Procaine HCl Injection, 1% and 2% ...................................................................... Watson Laboratories, Inc., Subsidiary
sradovich on DSK3GMQ082PROD with NOTICES
of Teva Pharmaceuticals USA, Inc.
ANDA 083128 ......... Hydrocortisone Acetate Injectable Suspension, 25 mg/mL ................................... Do.
ANDA 090181 ......... Ifosfamide for Injection, 1 g/20 mL and 3 g/60 mL ............................................... Fresenius Kabi USA, LLC, Three Cor-
porate Dr., Lake Zurich, IL 60047.
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Document Created: 2018-08-08 02:05:54
Document Modified: 2018-08-08 02:05:54
| 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 | 83 FR 39100 |
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