Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products; Correction, 79912 [2015-32252]

Download as PDF 79912 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Pretest .......................................................................... Main Study Screener ................................................... Main Study ................................................................... 640 2,112 1,056 1 1 1 640 2,112 1,056 0.75 (45 minutes) 0.08 (5 minutes) 0.75 (45 minutes) 480 169 792 Total ...................................................................... 5,193 1 5,193 ................................ 1,560 1 There are no capital costs or operating and maintenance costs associated with the collection of information. tkelley on DSK3SPTVN1PROD with NOTICES V. References The following references are on display in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https:// www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Zhong W., H. Maradit-Kremers, J.L. St. Sauver, et al., ‘‘Age and Sex Patterns of Drug Prescribing in a Defined American Population.’’ Mayo Clinic Proceedings. 88(7):697–707, 2013. 2. Depp C.A., D.A. Schkade, W.K. Thompson, D.V. Jeste. ‘‘Age, Affective Experience, and Television Use.’’ American Journal of Preventative Medicine. 39:173–8, 2010. 3. Agrawal Y., E.A. Platz, J.K. Niparko. ‘‘Prevalence of Hearing Loss and Differences by Demographic Characteristics Among US Adults.’’ Archives of Internal Medicine. 168(14):1522–30, 2008. 4. Cruickshanks K.J., T.L. Wiley, T.S. Tweed, et al., ‘‘Prevalence of Hearing Loss in Older Adults in Beaver Dam, Wisconsin.’’ American Journal of Epidemiology. 148(9):879–86, 1998. 5. Lin FR, R. Thorpe, S. Gordon-Salant, L. Ferrucci. ‘‘Hearing Loss Prevalence and Risk Factors Among Older Adults in the United States.’’ The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. 66A(5):582–90, 2011. 6. Garstecki DC, S.F. Erler. ‘‘Hearing Loss, Control, and Demographic Factors Influencing Hearing Aid Use Among Older Adults.’’ Journal of Speech, Language, and Hearing Research. 41:527–37, 1998. 7. Gates G.A., J.C. Cooper. ‘‘Incidence of Hearing Decline in the Elderly.’’ Acta Oto-laryngol. 111:240–8, 1991. 8. Humes L.E. ‘‘Speech Understanding in the Elderly.’’ Journal of the American Academy of Audiology. 7:161–7, 1996. 9. U.S. Food and Drug Administration. Code of Federal Regulations. Prescription drug advertisements, 21 CFR Sect. 202.1. 2013. (https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfCFR/ VerDate Sep<11>2014 18:05 Dec 22, 2015 Jkt 238001 CFRSearch.cfm?fr=202.1) 10. Wingfield A., L.W. Poon, L. Lombardi, D. Lowe. ‘‘Speed of Processing in Normal Aging: Effects of Speech Rate, Linguistic Structure, and Processing Time.’’ The Journals of Gerontology. 40(5):579–85, 1985. 11. Kramer A.F., S. Hahn, D. Gopher. ‘‘Task Coordination and Aging: Explorations of Executive Control Processes in the Task Switching Paradigm.’’ Acta Psychologica. 101:339–78, 1999. 12. Naveh-Benjamin M., J. Guez, A. Kilb, S. Reedy. ‘‘The Associative Memory Deficit of Older Adults: Further Support Using Face-Name Associations.’’ Psychology and Aging. 19(3):541–6, 2004. 13. Sommers M.S., N. Tye-Murray, B. Spehar. ‘‘Auditory-Visual Speech Perception and Auditory-Visual Enhancement in Normal-Hearing Younger and Older Adults.’’ Ear and Hearing. 26(3):263–75, 2005. 14. Watson J.M., K.B. McDermott, D.A. Balota. ‘‘Attempting to Avoid False Memories in the Deese/RoedigerMcDermott Paradigm: Assessing the Combined Influence of Practice and Warnings in Young and Old Adults.’’ Memory and Cognition. 32(1):135–41, 2004. 15. Gates G.A., M.P. Feeney, D. Mills. ‘‘CrossSectional Age-Changes of Hearing in the Elderly.’’ Ear and Hearing. 29(6):865–74, 2008. 16. Morrell C.H., S. Gordon-Salant, J.D. Pearson, L.J. Brant, J.L. Fozard. ‘‘Ageand Gender-Specific Reference Ranges for Hearing Level and Longitudinal Changes in Hearing Level.’’ Journal of the Acoustical Society of America. 100(4)Pt. 1:1949–67, 1996. 17. Cutler A., D. Dahan, W. van Donselaar. ‘‘Prosody in the Comprehension of Spoken Language: A Literature Review.’’ Language and Speech. 40(2):141–201, 1997. Dated: December 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–32251 Filed 12–22–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0873] Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice entitled ‘‘Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products’’ that appeared in the Federal Register of December 15, 2015 (80 FR 77637). The document solicited comments on the bar code label requirements for human drug and biological products. The document was published with an incorrect docket number. This document corrects that error. SUMMARY: Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. FOR FURTHER INFORMATION CONTACT: In the Federal Register of Tuesday, December 15, 2015, in FR Doc. 2015–31402, the following correction is made: 1. On page 77637, in the second column, the docket number is corrected to read FDA–2012–N–0873. SUPPLEMENTARY INFORMATION: Dated: December 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–32252 Filed 12–22–15; 8:45 am] BILLING CODE 4164–01–P Frm 00096 Fmt 4703 Sfmt 9990 E:\FR\FM\23DEN1.SGM 23DEN1

Agencies

[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Page 79912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0873]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Bar Code Label Requirement for Human Drug and 
Biological Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
entitled ``Agency Information Collection Activities: Proposed 
Collection; Comment Request; Bar Code Label Requirement for Human Drug 
and Biological Products'' that appeared in the Federal Register of 
December 15, 2015 (80 FR 77637). The document solicited comments on the 
bar code label requirements for human drug and biological products. The 
document was published with an incorrect docket number. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, December 
15, 2015, in FR Doc. 2015-31402, the following correction is made:
    1. On page 77637, in the second column, the docket number is 
corrected to read FDA-2012-N-0873.

    Dated: December 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32252 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P
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